Powered Laser Surgical Instrument
The Powered Laser Surgical Instrument (product code GEX) is a laser-based device that uses coherent, collimated, and typically monochromatic radiation to cut, destroy, remove, or coagulate tissue in general and plastic surgery, as well as related specialties including dermatology, podiatry, otolaryngology, gynecology, neurosurgery, orthopedics, dental and oral surgery. The underlying classification regulation (21 CFR 878.4810) addresses carbon dioxide or argon lasers intended for tissue cutting and coagulation. This device is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification; it is also eligible for third-party review.
Basic Information
- Product Code
- GEX
- Device Class
- FDA class 2
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
Definition
A laser (light amplification by stimulated emission of radiation) based device having coherence, collimated and typically monochromatic radiation. Typically indicated to to cut, destroy, remove or coagulate tissue, generally soft tissue, for general surgical purpose in medical specialties of general and plastic surgery, dermatology/aesthetic, podiatry, otolaryngology (ent), gynecology, neurosurgery, orthopedics (soft tissue), dental and oral surgery, and dentistry. The classification regulation 21 cfr 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, remove or coagulate tissue by the light.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2794 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K251149 | AviClear Laser System | Jul 11, 2025 | Substantially Equivalent | Cutera, Inc. |
| K251759 | Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers | Jul 09, 2025 | Substantially Equivalent | Boston Scientific Corporation |
| K250165 | Pastelle | Jul 03, 2025 | Substantially Equivalent | WONTECH Co., Ltd. |
| K251049 | SurgiLight 1470 Diode Laser System (Model:Halo) | Jul 02, 2025 | Substantially Equivalent | Micro-Energy Medical Technology Co., Ltd |
| K243701 | AuroLase® System | Jul 02, 2025 | Substantially Equivalent | Nanospectra Biosciences, Inc. |
| K251329 | Diode laser device (RF3120-BI) | Jun 27, 2025 | Substantially Equivalent | RiSu Medical Technology Co., Ltd. |
| K251632 | Optimas MAX System | Jun 26, 2025 | Substantially Equivalent | InMode Ltd. |
| K250936 | Q-Switched Nd:YAG Laser (SHE-LSP101-1) | Jun 12, 2025 | Substantially Equivalent | Beijing Sano Laser S&T Development Co.,Ltd |
| K250782 | Fractional CO2 Laser Machine | Jun 12, 2025 | Substantially Equivalent | Zhengzhou PZ Laser Slim Technology Co., Ltd. |
| K243683 | Deka Bluebeam | Jun 12, 2025 | Substantially Equivalent | El.En. S.p.A. |
| K250465 | CO2 Laser Machine (Lume) | Jun 09, 2025 | Substantially Equivalent | Nanjing Bestview Laser S&T Co., Ltd. |
| K250722 | Nd: YAG Laser Therapy System (QN-1) | Jun 06, 2025 | Substantially Equivalent | Hebei JT Medical Co., Ltd. |
| K240983 | Discovery Pico; Discovery Pico Plus; Discovery Pico Derm | Jun 06, 2025 | Substantially Equivalent | Quanta System SpA |
| K250195 | MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60) | May 30, 2025 | Substantially Equivalent | MateLaser, Inc. |
| K251230 | The Alma Hybrid Laser System | May 21, 2025 | Substantially Equivalent | Alma Lasers, Inc |
| K251288 | Veincare | May 14, 2025 | Substantially Equivalent | WONTECH CO., LTD. |
| K250041 | Medical Picosecond ND: YAG Laser System (PZ-6) | May 14, 2025 | Substantially Equivalent | Zhengzhou PZ Laser Slim Technology Co., Ltd. |
| K250431 | Medical Diode Laser Hair Removal System (MNLT-D1) | May 12, 2025 | Substantially Equivalent | Shandong Moonlight Electronics Tech Co.,Ltd. |
| K251094 | Alma Veil | May 06, 2025 | Substantially Equivalent | Won Tech Co., Ltd. |
| K242951 | Diode laser hair removal machine (QDTM-02) | Apr 28, 2025 | Substantially Equivalent | Beijing Nubway S&T Co., Ltd. |
| K250206 | Diode laser system (Night Universe; Predator) | Apr 24, 2025 | Substantially Equivalent | Ivylaser (Beijing) Technology Co.,Ltd |
| K250183 | CO2 Laser System (CO2 Laser SST-L23) | Apr 24, 2025 | Substantially Equivalent | Zhuozhou Summer Star Technologies Co., Ltd |
| K250809 | Stellar M22 | Apr 16, 2025 | Substantially Equivalent | Lumenis Be Ltd. |
| K243044 | Alma Harmony | Apr 11, 2025 | Substantially Equivalent | Alma Lasers, Inc. |
| K250656 | Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75) | Apr 04, 2025 | Substantially Equivalent | Wuhan Pioon Technology Co.,Ltd. |
| K250189 | AdvaTx | Apr 01, 2025 | Substantially Equivalent | AdvaLight APS |
| K250018 | Medical Diode Laser Systems (THEIA808) | Apr 01, 2025 | Substantially Equivalent | Gigaalaser Company Ltd. |
| K243630 | Medical Laser System Incanto / Evoline Platinum /Evoline | Mar 21, 2025 | Substantially Equivalent | SOLAR LS CJSC |
| K241791 | Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D) | Mar 19, 2025 | Substantially Equivalent | Gigaalaser Company Ltd. |
| K250113 | neoLaser Laser Surgery Fibers | Mar 13, 2025 | Substantially Equivalent | G.N.S neoLaser Ltd. |
| K243993 | Photon Therapy Apparatus (BL-10) | Mar 13, 2025 | Substantially Equivalent | Xemis Medical Technology (Shenzhen) Co., Ltd. |
| K243957 | PICOALEX | Mar 12, 2025 | Substantially Equivalent | WONTECH CO., LTD. |
| K242207 | NOABLE LASER | Mar 07, 2025 | Substantially Equivalent | Daeju Meditech Engineering Co., Ltd. |
| K242943 | Q Switched Nd:YAG Laser machine (QNHF-01) | Mar 03, 2025 | Substantially Equivalent | Beijing Nubway S&T Co., Ltd. |
| K234004 | Medical diode laser systems (CHARISMA, REGAL) | Feb 20, 2025 | Substantially Equivalent | Reveal Lasers Ltd. |
| K243588 | Single Use CO2 Laser Fiber (HAF005001) | Feb 19, 2025 | Substantially Equivalent | Quanta System SpA |
| K241643 | WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R) | Feb 14, 2025 | Substantially Equivalent | WONTECH Co., Ltd |
| K241527 | Pastelle Pro | Feb 14, 2025 | Substantially Equivalent | Wontech Co., Ltd. |
| K243780 | HELIOS 785 Pico (1754V2) | Feb 07, 2025 | Substantially Equivalent | Laseroptek Co., Ltd. |
| K243465 | Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal Device (M-I-X MEDICAL); Diode Laser Hair Removal Device (GENESIS); Diode Laser Hair Removal Device (Lotus); Diode Laser Hair Removal Device (Ultimate) | Feb 06, 2025 | Substantially Equivalent | Guangzhou CHUANG ZAO MEI Technology Co., Ltd. |
| K241270 | BTL-754 | Jan 30, 2025 | Substantially Equivalent | BTL Industries, Inc. |
| K242941 | CO2 Laser Therapy Systems (SHE-LSP003-1) | Jan 27, 2025 | Substantially Equivalent | Beijing Sano Laser S&T Development Co., Ltd. |
| K243445 | Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) | Dec 30, 2024 | Substantially Equivalent | Bios S.r.l. |
| K243141 | Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser System (Aurolance 980); Diode Laser System (Aurolance 810); Diode Laser System (Aurolance AM) | Dec 26, 2024 | Substantially Equivalent | JiangXi Medex Technology Co., Ltd |
| K243037 | Diode Laser System model Dawn-S | Dec 26, 2024 | Substantially Equivalent | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd |
| K243121 | SLT Select Fiber Delivery System and Contact Tips (models: SSRH 8-SMA; TCRH 7-SMA; FEF 2.2-SMA; CFE 0.6-SMA; SSRH 8Z-SMA; SSRH 4-SMA; SSRH 6-SMA; SSRH 9-SMA; SSRH 10-SMA; SSRH 11-SMA; SSRH 7L-SMA; TCRH 7Z-SMA; FEF 1.8-SMA; CFE 0.55-SMA; CFE 0.36-SMA; LAL 550-SMA; LAL 550Z-SMA; LAL 365-SMA; LAL 365Z-SMA; ER2; ERP2; GR2; GRP2; ER4; ERP4; GR4; GRP4; ER6; ERP6; GR6; GRP6; ER8; ERP8; GR8; GRP8; ER10; ERP10; GR10; GRP10; ER12; ERP12; GR12; GRP12; MD2.5; MD3.5; HP1.0; MTP1.5; MTP3.5; MTRG1.5; | Dec 22, 2024 | Substantially Equivalent | JiangXi Medex Technology Co.,Ltd |
| K243147 | LGO-Surgical Laser Fibers | Dec 21, 2024 | Substantially Equivalent | Light Guide Optics International Ltd. |
| K242534 | HandPICO Fractional Laser Handpiece Tip | Dec 20, 2024 | Substantially Equivalent | Vydence Medical |
| K241670 | Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2) | Dec 20, 2024 | Substantially Equivalent | Beijing ADSS Development Co., Ltd. |
| K242987 | Thulium Fiber Laser (FiberLAZE+, FiberLAZE) | Dec 17, 2024 | Substantially Equivalent | Allengers Global Healthcare Private Limited |
| K242293 | Medical Thulium Fiber Laser Systems (UroFiber 60Q) | Nov 19, 2024 | Substantially Equivalent | Rhein Laser Technologies Co., Ltd. |
| K241498 | Diode laser Treatment System (K18) | Nov 18, 2024 | Substantially Equivalent | Hebei Keylaser Sci-Tech Co., Ltd. |
| K241930 | Veincare | Nov 14, 2024 | Substantially Equivalent | Wontech Co., Ltd. |
| K241646 | ORTIV (ORTIV-BL, ORTIV-WH) | Nov 01, 2024 | Substantially Equivalent | MVITRO CO., LTD. |
| K240543 | Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia) | Oct 24, 2024 | Substantially Equivalent | Medency S.r.l. |
| K242183 | Fractional CO2 Laser Therapy System (EXFU CO2) | Oct 23, 2024 | Substantially Equivalent | Weifang Mingliang Electronics CO., LTD. |
| K242132 | FREDDO | Oct 18, 2024 | Substantially Equivalent | Fabinject lndustria e Comercio lmportacao e Exportacao Ltda |
| K242035 | Accure Laser System | Oct 11, 2024 | Substantially Equivalent | Accure Acne, Inc |
| K241951 | Lasya-Trinity | Oct 10, 2024 | Substantially Equivalent | Bluecore Company Co., Ltd. |
| K241092 | Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT | Oct 10, 2024 | Substantially Equivalent | Quanta System S.p.A. |
| K231948 | MEDIYAG | Oct 09, 2024 | Substantially Equivalent | Medicreations LLC |
| K242206 | ACTIVO | Sep 27, 2024 | Substantially Equivalent | Daeju Meditech Engineering Co., Ltd. |
| K241860 | Diode Laser Hair Removal System | Sep 25, 2024 | Substantially Equivalent | Beijing Winkonlaser Technology Limited. |
| K240604 | MTONE EVO (MTONE EVO) | Sep 20, 2024 | Substantially Equivalent | M&T S.r.l. |
| K241771 | Liftendo; Liftendo 2.0 | Sep 16, 2024 | Substantially Equivalent | Medical San Indústria de Equipamentos Médicos Ltda. |
| K242349 | FoLix | Sep 09, 2024 | Substantially Equivalent | Lumenis Be Ltd. |
| K241672 | COPRO 3 | Sep 06, 2024 | Substantially Equivalent | AMT Engineering Co., Ltd |
| K242251 | Litho 60; Litho 100; Litho 150 | Sep 03, 2024 | Substantially Equivalent | Quanta System SpA |
| K242202 | LightWalker Laser System Family | Aug 23, 2024 | Substantially Equivalent | Fotona d.o.o. |
| K242191 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) | Aug 23, 2024 | Substantially Equivalent | Olympus Surgical Technologies America |
| K242142 | Fraxel® FTX Laser System | Aug 21, 2024 | Substantially Equivalent | Solta Medical |
| K241699 | SUPER VELOCE | Aug 13, 2024 | Substantially Equivalent | Ilooda Co,.Ltd. |
| K241547 | Diode Laser Therapy Device (DF-DIODE LASER-S1) | Aug 13, 2024 | Substantially Equivalent | WeiFang Dragonfly Electronics Technology Co., Ltd |
| K241656 | Eneka Selectif | Aug 12, 2024 | Substantially Equivalent | TermoSalud |
| K231950 | MEDIDIODE | Aug 09, 2024 | Substantially Equivalent | Medicreations LLC |
| K241642 | Diode Laser Hair Removal System (MBT-Diode Laser) | Aug 02, 2024 | Substantially Equivalent | Beijing Mega Beauty Technology Co.,Ltd. |
| K241293 | LED Light Therapy Device, ELIXIR MD | Jul 08, 2024 | Substantially Equivalent | Yassen Wellness LLC |
| K241600 | Dermablate | Jul 03, 2024 | Substantially Equivalent | Asclepion Laser Technologies GmbH |
| K241406 | Lavieen | Jun 28, 2024 | Substantially Equivalent | Won Tech Co., Ltd. |
| K241144 | Picosecond Nd:YAG Laser (PICOCAREMAJESTY) | Jun 24, 2024 | Substantially Equivalent | Won Tech Co., Ltd. |
| K241459 | MOTUS PRO Family | Jun 21, 2024 | Substantially Equivalent | El.En. S.p.A. |
| K240611 | IVYLASER Diode laser hair removal system (IVY-HR-Alloy) | Jun 20, 2024 | Substantially Equivalent | Ivylaser (Beijing) Technology Co., Ltd |
| K240747 | Medical Diode Laser (M2-GK) | Jun 17, 2024 | Substantially Equivalent | Wuhan Pioon Technology Co.,Ltd. |
| K241407 | Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) | Jun 14, 2024 | Substantially Equivalent | Bios S.r.l. |
| K241358 | BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E | Jun 13, 2024 | Substantially Equivalent | Sun Pharmaceutical Industries, Inc. |
| K233007 | Picosecond Nd:YAG Laser System; PICO LEGEND | Jun 12, 2024 | Substantially Equivalent | AMI Inc. |
| K240644 | Medical Diode Laser (S1Pro) | Jun 10, 2024 | Substantially Equivalent | Wuhan Pioon Technology Co.,Ltd. |
| K240222 | Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024) | Jun 04, 2024 | Substantially Equivalent | Aesthetic Technology Ltd |
| K240159 | InnoVoyce VYLO | May 29, 2024 | Substantially Equivalent | InnoVoyce |
| K240874 | Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B) | May 28, 2024 | Substantially Equivalent | TheraLaser Medtech (China) Co., Ltd. |
| K233344 | Regenalase Laser System | May 28, 2024 | Substantially Equivalent | IPG Medical |
| K240520 | Diode Laser Hair Removal System (SH-VD910) | May 20, 2024 | Substantially Equivalent | Beijing Sea Heart International Science And TechnologyCo.Ltd |
| K240474 | Multi-function Platform Systems (BL-M10) | May 20, 2024 | Substantially Equivalent | Shanghai Bele Medical Technology Co.,Ltd |
| K240752 | DEKA TORO | May 16, 2024 | Substantially Equivalent | El.En. S.p.A. |
| K240386 | Picosecond Nd:YAG Laser Systems (BL-C10) | May 16, 2024 | Substantially Equivalent | Shanghai Bele Medical Technology Co.,Ltd |
| K233803 | UltraClear Laser System (N/A) | May 08, 2024 | Substantially Equivalent | Acclaro Corporation |
| K233157 | VaporMAX LDD; MOJo LDD; MegaJOULE LDD | May 03, 2024 | Substantially Equivalent | InnovaQuartz LLC |
| K232858 | ORskin Blue | May 01, 2024 | Substantially Equivalent | Megabay S.A. |
| K240118 | Picosecond Nd:YAG Laser System | Apr 30, 2024 | Substantially Equivalent | Smedtrum Medical Technology Co., Ltd. |
| K240816 | MeDioStar | Apr 23, 2024 | Substantially Equivalent | Asclepion Laser Technologies GmbH |
| K232133 | Co2 Laser System, Models: PureLase And VanLase | Apr 16, 2024 | Substantially Equivalent | CPMT Laser (Canadian Pioneer Medical Technology Corporation) |
| K233757 | TitanPico Laser Workstation (PICO-450) | Apr 11, 2024 | Substantially Equivalent | Rhein Laser Technologies Co., Ltd. |
| K234057 | NIRVANA | Apr 10, 2024 | Substantially Equivalent | El.En. S.p.A. |
| K234085 | LUNE PureHygiene | Mar 25, 2024 | Substantially Equivalent | Enamel Pure |
| K240179 | Medical Diode Laser (Model: L2) | Mar 21, 2024 | Substantially Equivalent | Wuhan Pioon Technology Co., Ltd. |
| K232568 | IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories | Mar 21, 2024 | Substantially Equivalent | IPG Medical Corporation |
| K240537 | SMARTXIDE PRO | Mar 20, 2024 | Substantially Equivalent | El.En. S.p.A. |
| K234104 | PICOANDY (Q-Switched Nd:YAG Laser) | Mar 15, 2024 | Substantially Equivalent | Won Tech Co., Ltd. |
| K240497 | Smartxide Tetra Pro | Mar 12, 2024 | Substantially Equivalent | El.En. S.p.A. |
| K240132 | EmoLED (v. 2-USA) | Mar 12, 2024 | Substantially Equivalent | Emoled, Srl |
| K240396 | Elite iQ PRO (M122K1) | Mar 08, 2024 | Substantially Equivalent | Cynosure, LLC. |
| K231876 | MultiPulse HoPLUS | Feb 22, 2024 | Substantially Equivalent | Asclepion Laser Technologies GmbH |
| K231896 | Diode Laser Therapy System | Feb 20, 2024 | Substantially Equivalent | Beijing ADSS Development Co., Ltd. |
| K231514 | Azure | Feb 14, 2024 | Substantially Equivalent | Daeshin Enterprise Co., Ltd. |
| K233024 | Alma Harmony | Feb 08, 2024 | Substantially Equivalent | Alma Lasers, Inc. |
| K233416 | Cryojet Plus (SHE-ACP001-1) | Feb 06, 2024 | Substantially Equivalent | Beijing Sano Laser S&T Development Co., Ltd |
| K233756 | Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755) | Feb 02, 2024 | Substantially Equivalent | Rhein Laser Technologies Co., Ltd. |
| K233143 | PiXel8-Reveal | Feb 02, 2024 | Substantially Equivalent | Rohrer Aesthetics |
| K233804 | Resonic Rapid Acoustic Pulse Device | Feb 01, 2024 | Substantially Equivalent | Zeltiq Aesthetics Inc. |
| K231910 | DermRays Revive | Jan 30, 2024 | Substantially Equivalent | Wuhan Lotuxs Technology Co., Ltd. |
| K233224 | Epilaser Pro | Jan 27, 2024 | Substantially Equivalent | Epilady 2000 LLC |
| K233077 | FlashHeal 2 (FlashHeal 2.0) | Jan 18, 2024 | Substantially Equivalent | InWound ApS |
| K232106 | Air Gap Fiber | Jan 08, 2024 | Substantially Equivalent | WON TECH Co., Ltd. |
| K221766 | Solon | Jan 05, 2024 | Substantially Equivalent | LMG Lasers Comercio, Importacao e Exportacao Ltda |
| K233304 | Omnimax S3, Omnimax S4 | Dec 22, 2023 | Substantially Equivalent | SharpLight Technologies Ltd |
| K233018 | PICOSECOND Nd:YAG Laser System | Dec 21, 2023 | Substantially Equivalent | IDS, Ltd. |
| K233237 | xeo+ Family | Dec 15, 2023 | Substantially Equivalent | Cutera, Inc. |
| K231061 | NeuroBlate System | Dec 08, 2023 | Substantially Equivalent | Monteris Medical |
| K232769 | BeaMed Laser Surgery Fibers | Dec 06, 2023 | Substantially Equivalent | BT BeaMedical Tachnoogies Ltd. (BeaMed) |
| K233301 | ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories | Dec 01, 2023 | Substantially Equivalent | Lumenis Be Ltd. |
| K232716 | Q-Switched Nd:Yag laser | Nov 30, 2023 | Substantially Equivalent | Hebei Zhemai Technology Co., Ltd |
| K232709 | Diode laser therapy device | Nov 30, 2023 | Substantially Equivalent | Hebei Zhemai Technology Co., Ltd |
| K232117 | Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) | Nov 28, 2023 | Substantially Equivalent | Wuhan Lotuxs Technology Co., Ltd. |
| K232532 | Nd:Yag Laser Therapy Systems | Nov 02, 2023 | Substantially Equivalent | Beijing UNT Technology Co., Ltd. |
| K233090 | DEKA AGAIN PRO family | Oct 27, 2023 | Substantially Equivalent | El. En. S.p.A. |
| K232236 | Echo | Oct 20, 2023 | Substantially Equivalent | Quanta System Spa |
| K231901 | Hakon, Hakon Smart | Sep 28, 2023 | Substantially Equivalent | Medical San Indústria de Equipamentos Médicos Ltda |
| K231894 | LED Spectrum therapy instrument | Sep 20, 2023 | Substantially Equivalent | Shenzhenshi Sincoheren S&T Development Co.,Ltd. |
| K231791 | PENTO Nd:YAG and Alexandrite laser system | Sep 15, 2023 | Substantially Equivalent | Ilooda Co,.Ltd. |
| K230535 | KARL STORZ Urological Laser Accessories | Sep 08, 2023 | Substantially Equivalent | Karl Storz SE & CO. KG |
| K223727 | Lavieen | Aug 25, 2023 | Substantially Equivalent | Won Tech Co., Ltd. |
| K231718 | Holmium Medical Laser | Aug 18, 2023 | Substantially Equivalent | Allengers Global Healthcare Private Limited |
| K230342 | Phototherapy System (OL-PDT950) | Aug 16, 2023 | Substantially Equivalent | Shanghai Omni Laser Skinology Co., Ltd. |
| K231054 | V-Laser | Aug 14, 2023 | Substantially Equivalent | WON TECH Co., Ltd. |
| K230268 | ZenPro 40 | Aug 10, 2023 | Substantially Equivalent | Bluecore Company Co Ltd |
| K231548 | Medical Diode Laser, Model S1Pro | Aug 03, 2023 | Substantially Equivalent | Wuhan Pioon Technology Co., Ltd. |
| K222862 | SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC | Jul 30, 2023 | Substantially Equivalent | Lotuxs Medtech (Suzhou) Co., Ltd. |
| K231945 | VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure Kits | Jul 20, 2023 | Substantially Equivalent | AngioDynamics, Inc. |
| K230077 | LaserME | Jul 17, 2023 | Substantially Equivalent | Neauvia North America |
| K230660 | AviClear Laser System | Jun 06, 2023 | Substantially Equivalent | Cutera, Inc. |
| K212734 | Diode laser therapy device | Jun 06, 2023 | Substantially Equivalent | TRIANGEL RSD LIMITED |
| K212733 | Diode laser therapy device | Jun 06, 2023 | Substantially Equivalent | Beijing Star New Tech Co., Ltd. |
| K231309 | SCAR 3 | Jun 02, 2023 | Substantially Equivalent | El.en Electroinc Engineering Spa |
| K230990 | Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) | Jun 01, 2023 | Substantially Equivalent | Candela Corporation |
| K230580 | Diode Laser System | May 26, 2023 | Substantially Equivalent | Smedtrum Medical Technology Co., Ltd. |
| K230460 | Laser Thermal Therapy Kit | May 22, 2023 | Substantially Equivalent | Elesta SPA |
| K230373 | HELIOS 785 Pico | May 22, 2023 | Substantially Equivalent | Laseroptek Co., Ltd. |
| K230340 | Lucas Plus | May 04, 2023 | Substantially Equivalent | AMT Engineering Co., Ltd |
| K222352 | Epildream HP 4000 MED | Apr 27, 2023 | Substantially Equivalent | D.E.A Project S.r.1. |
| K230819 | OmniGuide RFID Surgical Laser Fibers | Apr 21, 2023 | Substantially Equivalent | Omni-Guide Holdings, Inc. |
| K230274 | Medical Diode Laser (M2) | Mar 31, 2023 | Substantially Equivalent | Wuhan Pioon Technology Co.,Ltd. |
| K223778 | Diode Laser Hair Removal System (RD-SLD600) | Mar 31, 2023 | Substantially Equivalent | Shanghai Omni Laser Skinology Co., Ltd. |
| K222485 | SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser | Mar 29, 2023 | Substantially Equivalent | IDS, Limited |
| K222983 | NeuroBlate Fusion-S Software V3.17 | Mar 15, 2023 | Substantially Equivalent | Monteris Medical, |
| K221623 | FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm | Mar 10, 2023 | Substantially Equivalent | GME German Medical Engineering GmbH |
| K230308 | Alma Harmony | Mar 01, 2023 | Substantially Equivalent | Alma Lasers, Inc. |
| K230371 | The Alma Soprano Titanium | Feb 22, 2023 | Substantially Equivalent | Alma Lasers Inc. |
| K213669 | LIGHTSCALPEL LS-4020 | Feb 15, 2023 | Substantially Equivalent | LightScalpel Inc |
| K223680 | Eneka Pro | Feb 10, 2023 | Substantially Equivalent | TermoSalud |
| K222751 | LED Light Therapy Device, KN-7000L | Feb 01, 2023 | Substantially Equivalent | Xuzhou Kernel Medical Equipment Co., Ltd. |
| K221306 | SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories | Jan 27, 2023 | Substantially Equivalent | Gyrus ACMI, Inc. |
| K223588 | PALLAS Premium | Jan 26, 2023 | Substantially Equivalent | Laseroptek Co., Ltd. |
| K223404 | Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V | Jan 20, 2023 | Substantially Equivalent | Quanta System, S.p.A. |
| K223540 | AvalancheLase Family | Jan 19, 2023 | Substantially Equivalent | Fotona d.o.o. |
| K223685 | SmoothCool HR System | Jan 04, 2023 | Substantially Equivalent | Jeisys Medical Inc |
| K222221 | DEKA HELIX | Jan 04, 2023 | Substantially Equivalent | El.En Electronic Engineering Spa |
| K223647 | CLEAR+BRILLIANT TOUCH® Laser System | Dec 29, 2022 | Substantially Equivalent | Solta Medical, Inc. |
| K213105 | Epilaser Absolute | Dec 13, 2022 | Substantially Equivalent | Epilady 2000 LLC |
| K222916 | US 450 Diode Laser Equipment | Dec 09, 2022 | Substantially Equivalent | Beijing Globalipl Development Co., Ltd. |
| K222701 | MANTA Laser | Nov 18, 2022 | Substantially Equivalent | SQUALUS MED Ltd. |
| K222673 | Alexandrite and Nd:YAG Laser models CANLASE and TORLASE | Nov 17, 2022 | Substantially Equivalent | Canadian Pioneer Medical Technology Corporation (CPMT LASER) |
| K222109 | Accure Laser | Nov 17, 2022 | Substantially Equivalent | Accure Acne, Inc. |
| K222915 | Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUS | Nov 15, 2022 | Substantially Equivalent | Canadian Pioneer Medical Technology Corporation (CPMT LASER) |
| K222800 | Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) | Nov 07, 2022 | Substantially Equivalent | Sanhe Laserconn Tech Co., Ltd. |
| K220853 | PicoWay Laser System | Oct 13, 2022 | Substantially Equivalent | Candela Corporation |
| K222064 | The Alma Soprano Titanium | Oct 12, 2022 | Substantially Equivalent | Alma Lasers Inc. |
| K221712 | Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm) | Oct 12, 2022 | Substantially Equivalent | Fotona d.o.o. |
| K222369 | PURE Laser | Oct 07, 2022 | Substantially Equivalent | Endymed Medical, Ltd. |
| K202953 | Aurolase Therapy, Laser Delivery Device (LDD) | Oct 03, 2022 | Substantially Equivalent | Nanospectra Biosciences, Inc. |
| K222629 | Resonic Rapid Acoustic Pulse Device | Sep 25, 2022 | Substantially Equivalent | Zeltiq Aesthetics, Inc. |
| K222555 | reepot Nd; YAG laser system | Sep 23, 2022 | Substantially Equivalent | Ilooda Co., Ltd. |
| K211605 | Dual Switch | Sep 22, 2022 | Substantially Equivalent | Laser Engineering, Inc. |
| K221597 | CO2 Laser System | Sep 15, 2022 | Substantially Equivalent | Smedtrum Medical Technology Co., Ltd. |
| K213267 | Dynamis Pro Family | Sep 08, 2022 | Substantially Equivalent | Fotona d.o.o. |
| K220531 | FOX 810, FOX 980 | Sep 01, 2022 | Substantially Equivalent | A.R.C. Laser GmbH |
| K221427 | V-Laser | Aug 24, 2022 | Substantially Equivalent | WON TECH Co., Ltd. |
| K220268 | Picosecond Laser System (Model PS10-A and PS10-B) | Aug 23, 2022 | Substantially Equivalent | Beijing ADSS Development Co., Ltd. |
| K212790 | XLase Plus | Aug 15, 2022 | Substantially Equivalent | Biotec Italia, SRL |
| K221789 | IRIS Pi Q switched Nd YAG laser | Aug 09, 2022 | Substantially Equivalent | Bio-Med USA Inc |
| K213252 | Dornier Thulio | Jul 27, 2022 | Substantially Equivalent | DornierMedTech America, Inc |
| K213761 | Joule diVa System | Jul 19, 2022 | Substantially Equivalent | Sciton, Inc |
| K212073 | Alma Diode Tabletop Laser | Jul 14, 2022 | Substantially Equivalent | Alma Lasers, Ltd. |
| K221083 | Smartlux Mini | Jul 12, 2022 | Substantially Equivalent | MEDMIX Co., Ltd. |
| K221571 | InMode Multi-system | Jun 30, 2022 | Substantially Equivalent | InMode Ltd. |
| K221312 | Diode Laser Hair Removal Device | Jun 29, 2022 | Substantially Equivalent | Guangzhou CHUANG ZAO MEI Technology Co., Ltd |
| K213726 | PL-1 Skin Treatment System | Jun 28, 2022 | Substantially Equivalent | Avava, Inc |
| K213250 | Secret Duo | Jun 24, 2022 | Substantially Equivalent | Ilooda Co Ltd |
| K211979 | Lumenis Y&R Laser System | Jun 21, 2022 | Substantially Equivalent | Lumenis Inc. |
| K212663 | HELIOS IV 785 | Jun 09, 2022 | Substantially Equivalent | Laseroptek Co., Ltd. |
| K214049 | Leaseir MHR Xcell | Jun 02, 2022 | Substantially Equivalent | Leaseir Technologies S.L.U. |
| K213261 | EpilME | Jun 02, 2022 | Substantially Equivalent | Neauvia North America |
| K220793 | InnoVoyce Laser Fiber | May 25, 2022 | Substantially Equivalent | InnoVoyce LLC |
| K220381 | Diode Laser Therapy Systems | May 20, 2022 | Substantially Equivalent | Beijing LaserTell Medical Co., Ltd. |
| K211534 | RevoLix HTL | May 19, 2022 | Substantially Equivalent | LISA Laser Products GmbH |
| K220467 | The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories | May 18, 2022 | Substantially Equivalent | Lumenis Be, Ltd. |
| K220041 | HandPICO | May 05, 2022 | Substantially Equivalent | Vydence Medical Industria E Comercio Ltda |
| K213594 | ECHOLASER X4 | May 03, 2022 | Substantially Equivalent | ELESTA SPA |
| K220189 | LISA Laser Surgical Fibers | Apr 29, 2022 | Substantially Equivalent | Omni-Guide Holdings, Inc. |
| K213889 | PicoStar | Apr 22, 2022 | Substantially Equivalent | Asclepion Laser Technologies GmbH |
| K210183 | Waterlase iPLus | Apr 21, 2022 | Substantially Equivalent | Biolase, Inc. |
| K213484 | SmoothCool HR System | Apr 20, 2022 | Substantially Equivalent | Jeisys Medical Inc |
| K213350 | mJOULE System and Accessories | Apr 15, 2022 | Substantially Equivalent | Sciton, Inc |
| K210634 | MCL 31 Dermablate System | Apr 13, 2022 | Substantially Equivalent | Asclepion Laser Technologies GmbH |
| K220103 | LED Therapy Device (Planar LED/Planar LED mini) | Apr 12, 2022 | Substantially Equivalent | Shenzhen Leaflife Technology Co., Ltd |
| K213557 | Finexel | Apr 12, 2022 | Substantially Equivalent | SNJ Co., Ltd |
| K213461 | AviClear Laser System | Mar 24, 2022 | Substantially Equivalent | Cutera, Inc. |
| K220426 | Fiber Dust PRO | Mar 16, 2022 | Substantially Equivalent | Quanta System Spa |
| K211722 | Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares | Feb 25, 2022 | Substantially Equivalent | Canadian Pioneer Medical Technology Corporation |
| K220020 | Cryo 7 | Feb 04, 2022 | Substantially Equivalent | Zimmer MedizinSysteme GmbH |
| K213569 | HOLLYWOOD SPECTRA Laser System | Feb 04, 2022 | Substantially Equivalent | Lutronic Corporation |
| K213554 | Sentient Manufacturing Laser Fiber | Feb 02, 2022 | Substantially Equivalent | Sentient Manufacturing LLC |
| K211228 | Rosso | Feb 02, 2022 | Substantially Equivalent | Quanta System SpA |
| K212611 | CO2 Laser Equipment | Feb 01, 2022 | Substantially Equivalent | Beijing Globalipl Development Co., Ltd. |
| K203395 | Platform treatment system | Jan 28, 2022 | Substantially Equivalent | Shanghai Apolo Medical Technology Co., Ltd. |
| K212478 | Dermatological diode laser system | Jan 14, 2022 | Substantially Equivalent | Beijing Stelle Laser Technology Co., Ltd. |
| K212127 | Picocaremajesty | Jan 07, 2022 | Substantially Equivalent | Won Tech Co., Ltd. |
| K213225 | Diode Laser System GP900A8, Diode Laser System GP900Q8 | Dec 22, 2021 | Substantially Equivalent | Shenzhen GSD Tech Co., Ltd. |
| K212492 | Frax 1940 for Nordlys and Frax Pro | Dec 20, 2021 | Substantially Equivalent | Candela Corporation |
| K202848 | S2 Pigment Removal System | Dec 14, 2021 | Substantially Equivalent | Lightsense Technologies Ltd |
| K210847 | UltraClear Fractional Laser System | Dec 10, 2021 | Substantially Equivalent | FA International, LP |
| K212573 | PicoLO Premium | Dec 08, 2021 | Substantially Equivalent | Laseroptek Co., Ltd. |
| K202175 | OxyLight 2.0 | Dec 02, 2021 | Substantially Equivalent | Raja Trading Company, Inc. |
| K202288 | Finebeam | Nov 19, 2021 | Substantially Equivalent | SNJ Co., Ltd. |
| K212607 | Darwin | Nov 15, 2021 | Substantially Equivalent | Luvo Medical Technologies, Inc |
| K212978 | Diode laser therapy system | Nov 10, 2021 | Substantially Equivalent | BEIJING UNT Technology Co., Ltd |
| K211517 | Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT Thulium Fiber Laser, Thulium Fiber Laser 1940 nm, Optica XT Thulium Fiber Laser 1940 nm, Optica XT 60 Thulium Fiber Laser 1940 nm, Optica XT Superpulse Thulium Fiber Laser 1940 nm, OptiLITE Laser Fibers and Accessories | Nov 09, 2021 | Substantially Equivalent | Convergent Laser Technologies |
| K212502 | Resonic Rapid Acoustic Pulse Device | Nov 05, 2021 | Substantially Equivalent | Soliton Inc. |
| K211977 | Medical Diode Laser Systems | Oct 26, 2021 | Substantially Equivalent | Wuhan Dimed Laser Technology Co., Ltd. |
| K202998 | Vydence Zye and Vydence One | Oct 26, 2021 | Substantially Equivalent | Vydence Medical Industria E Comercio Ltda |
| K212793 | Laser Treatment System, Model: Hera, Armo | Oct 25, 2021 | Substantially Equivalent | Canadian Pioneer Medical Technology Corporation |
| K211735 | CO2 Laser Machine, Model: BW-203B | Oct 22, 2021 | Substantially Equivalent | Zhengzhou Bestview St Co., Ltd. |
| K212270 | DEKA LipoAI | Oct 21, 2021 | Substantially Equivalent | EL.EN Electronic Engineering Spa |
| K212703 | AcuPulse CO2 Laser System, Delivery Devices and Accessories | Oct 19, 2021 | Substantially Equivalent | Lumenis, Ltd. |
| K201773 | PICOHI | Oct 19, 2021 | Substantially Equivalent | Hironic Co., Ltd. |
| K212082 | Picore | Oct 06, 2021 | Substantially Equivalent | Bio-Med USA Inc |
| K203799 | ProFlex CO2 Laser Fiber | Sep 20, 2021 | Substantially Equivalent | InnovaQuartz LLC |
| K211637 | AROMA GRAND | Sep 03, 2021 | Substantially Equivalent | Daeju Meditech Engineering Co., Ltd. |
| K210951 | Leonardo Mini Blue | Sep 01, 2021 | Substantially Equivalent | CeramOptec GmbH |
| K211362 | SCAR 3 | Aug 25, 2021 | Substantially Equivalent | EL. En Electronic Engineering SPA |
| K211761 | UltraLase Flexible CO2 Laser Waveguide | Jul 30, 2021 | Substantially Equivalent | W & R Investments, LLC dba Laser Engineering |
| K211335 | Diode Laser Machine, Model Number: BM-100 | Jul 28, 2021 | Substantially Equivalent | Zhengzhou Bestview St Co., Ltd. |
| K203728 | Darwin | Jul 14, 2021 | Substantially Equivalent | Luvo Medical Technologies, Inc |
| K211821 | DEKA Motus AZ | Jul 06, 2021 | Substantially Equivalent | El.En Electronic Engineering SPA |
| K203441 | The Alma Hybrid Laser System | Jul 02, 2021 | Substantially Equivalent | Alma Lasers, Ltd. |
| K202991 | Fotona XPulse Pro Laser Platform | Jun 22, 2021 | Substantially Equivalent | Fotona d.o.o. |
| K202828 | Surgical Green Laser System | Jun 04, 2021 | Substantially Equivalent | Realton (Suzhou) Medical Technology Co., Ltd. |
| K211401 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) | Jun 03, 2021 | Substantially Equivalent | Gyrus ACMI, Inc. |
| K210535 | UltraLight LED System | May 24, 2021 | Substantially Equivalent | Rohrer Aesthetics, LLC |
| K210168 | Diode Laser Therapy Systems | May 10, 2021 | Substantially Equivalent | Beijing Kes Biology Technology CO., LTD. |
| K210925 | Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser Fiber | Apr 28, 2021 | Substantially Equivalent | Boston Scientific |
| K210964 | Resonic Rapid Acoustic Pulse Device | Apr 27, 2021 | Substantially Equivalent | Soliton Inc. |
| K210663 | Dermatological Diode Laser Systems | Apr 26, 2021 | Substantially Equivalent | Beijing HuaCheng Taike Technology Co., Ltd. |
| K202258 | ERISE Laser handpiece | Apr 26, 2021 | Substantially Equivalent | EL.EN. Electronic Engineering Spa |
| K202257 | Dermatological Diode Laser Systems | Apr 23, 2021 | Substantially Equivalent | Zhuolu Jontelaser Manufacturing Technology Co., Ltd. |
| K202043 | Secret Duo | Apr 23, 2021 | Substantially Equivalent | Ilooda Co Ltd |
| K203491 | PicoLO Nd: YAG Picosecond Laser System | Apr 07, 2021 | Substantially Equivalent | Laseroptek Co., Ltd. |
| K201171 | LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable | Apr 02, 2021 | Substantially Equivalent | LEONI Fiber Optics, Inc. |
| K210226 | PicoSure Workstation | Mar 30, 2021 | Substantially Equivalent | Cynosure LLC |
| K203788 | DermaV Laser System | Mar 26, 2021 | Substantially Equivalent | Lutronic Corporation |
| K201466 | Tranberg CLS Laser Applicator | Mar 26, 2021 | Substantially Equivalent | Clinical Laserthermia Systems, AB |
| K202985 | LightWalker Laser System Family | Mar 19, 2021 | Substantially Equivalent | Fotona d.o.o. |
| K210142 | Fiber Dust | Mar 11, 2021 | Substantially Equivalent | Quanta System Spa |
| K203054 | FlexSys | Mar 05, 2021 | Substantially Equivalent | GME German Medical Engineering GmbH |
| K210033 | Laser Treatment System, Model: NYX and Grace | Feb 26, 2021 | Substantially Equivalent | Canadian Pioneer Medical Technology Corporation |
| K202702 | FLARE Single-Use Surgical Laser Fiber | Feb 26, 2021 | Substantially Equivalent | Realton (Suzhou) Medical Technology Co., Ltd. |
| K203804 | Global Med Systems Milesman Compact Laser | Feb 23, 2021 | Substantially Equivalent | Global Med Systems SL |
| K201801 | Rapid Acoustic Pulse Device | Jan 29, 2021 | Substantially Equivalent | Soliton Inc. |
| K193266 | MIIN | Jan 22, 2021 | Substantially Equivalent | Medico USA Inc. |
| K203241 | OmniGuide BeamPath OTO-U Fiber | Jan 14, 2021 | Substantially Equivalent | OmniGuide, Inc. |
| K203544 | UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories | Dec 24, 2020 | Substantially Equivalent | Lumenis Ltd. |
| K201594 | Primelase Excellence | Dec 17, 2020 | Substantially Equivalent | High Technology Products SLU |
| K202601 | Single-use Sterile medical laser fiber | Dec 15, 2020 | Substantially Equivalent | Realton (Suzhou) Medical Technology Co., Ltd |
| K201687 | Avenda Health Treatment System | Nov 30, 2020 | Substantially Equivalent | Avenda Health, Inc. |
| K202250 | Dermatological Carbon Dioxide Laser Systems | Nov 25, 2020 | Substantially Equivalent | Zhuolu Jontelaser Manufacturing Technology Co., Ltd |
| K202980 | Laser Therapy Device | Nov 19, 2020 | Substantially Equivalent | Shenzhen Leaflife Technology Co., Ltd |
| K202172 | StarWalker | Nov 19, 2020 | Substantially Equivalent | Fotona d.o.o. |
| K200693 | K2 MOBILE | Nov 19, 2020 | Substantially Equivalent | HULASER, Inc. |
| K202503 | Chrome | Nov 18, 2020 | Substantially Equivalent | Quanta System Spa |
| K202758 | Nd: YAG Laser Therapy Systems HM-YL900 | Nov 16, 2020 | Substantially Equivalent | Shangdong Huamei Technology Co., Ltd. |
| K202428 | AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories | Oct 22, 2020 | Substantially Equivalent | Lumenis Ltd. |
| K202041 | Opera Evo | Oct 15, 2020 | Substantially Equivalent | Quanta System SpA |
| K201056 | NeuroBlate System | Aug 21, 2020 | Substantially Equivalent | Monteris Medical, Inc. |
| K201406 | Picowon | Jul 22, 2020 | Substantially Equivalent | WON TECH Co., Ltd. |
| K201663 | AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories | Jul 16, 2020 | Substantially Equivalent | Lumenis Ltd. |
| K201109 | CO2 Laser Therapy System | Jul 15, 2020 | Substantially Equivalent | Shanghai Apolo Medical Technology Co., Ltd. |
| K201455 | Litho 150, Cyber Ho 150 | Jun 30, 2020 | Substantially Equivalent | Quanta System Spa |
| K200736 | Stardust Med | Jun 26, 2020 | Substantially Equivalent | I.T.S. Group S.R.L. |
| K193477 | Nd: YAG Laser Therapy Systems | Jun 24, 2020 | Substantially Equivalent | Beijing Kes Biology Technology Co., Ltd. |
| K200786 | Venus Epileve | Jun 09, 2020 | Substantially Equivalent | Venus Concept USA Inc. |
| K200042 | CO2 Laser System | Jun 09, 2020 | Substantially Equivalent | Beijing Superlaser Technology Co., Ltd. |
| K200104 | Oxylight | Jun 04, 2020 | Substantially Equivalent | RAJA Trading Company, Inc. |
| K200116 | PicoSecond Nd: YAG Laser System | May 28, 2020 | Substantially Equivalent | Shanghai Apolo Medical Technology Co., Ltd. |
| K200525 | Medical Diode Laser Hair Removal System | May 27, 2020 | Substantially Equivalent | Weifang Mingliang Electronics CO., LTD |
| K201111 | GentleMax Pro Plus | May 26, 2020 | Substantially Equivalent | Candela Corporation |
| K200751 | Photodynamic Therapy (PDT) Equipment | May 21, 2020 | Substantially Equivalent | Shangdong Huamei Technology Co., Ltd. |
| K200659 | Dermalux Tri-Wave MD | May 09, 2020 | Substantially Equivalent | Aesthetic Technology Ltd. |
| K192856 | MT One | Apr 24, 2020 | Substantially Equivalent | M&T SRL |
| K200118 | Diode Laser Therapy Device | Apr 17, 2020 | Substantially Equivalent | Shanghai Apolo Medical Technology Co., Ltd. |
| K193464 | ND:YAG Laser | Apr 13, 2020 | Substantially Equivalent | Beijing Superlaser Technology Co., Ltd. |
| K191970 | Diode Laser Hair Removal System | Apr 06, 2020 | Substantially Equivalent | Beijing Sano Laser S&T Development Co., Ltd |
| K192735 | Diode Laser Hair Removal Machine | Apr 03, 2020 | Substantially Equivalent | Beijing Lead Beauty S & T Co., Ltd |
| K193656 | SkyPulse | Mar 27, 2020 | Substantially Equivalent | Fotona d.o.o. |
| K192951 | Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun | Mar 26, 2020 | Substantially Equivalent | Ellipse A/S |
| K193661 | LightWalker Laser System Family | Mar 25, 2020 | Substantially Equivalent | Fotona d.o.o. |
| K193609 | Q Switched Nd: YAG Laser machine | Mar 20, 2020 | Substantially Equivalent | Beijing Lead Beauty S & T Co., Ltd |
| K192272 | Wolf445nm | Mar 17, 2020 | Substantially Equivalent | A.R.C. Laser GmbH |
| K200110 | SANDRO Dual | Mar 16, 2020 | Substantially Equivalent | WON TECH Co., Ltd. |
| K193486 | Epic 980 | Mar 16, 2020 | Substantially Equivalent | Biolase, Inc |
| K192483 | MeDioStar | Mar 13, 2020 | Substantially Equivalent | ASCLEPION LASER TECHNOLOGIES GMBH |
| K193367 | elysion-pro | Mar 12, 2020 | Substantially Equivalent | High Technology Products SLU |
| K200331 | Rapid Acoustic Pulse Device | Mar 10, 2020 | Substantially Equivalent | Soliton Inc. |
| K193446 | Bare: 808 | Mar 10, 2020 | Substantially Equivalent | LUVO Medical Technologies, Inc |
| K193426 | Elite iQ | Mar 09, 2020 | Substantially Equivalent | Cynosure LLC |
| K200234 | Surgical laser fibers | Feb 25, 2020 | Substantially Equivalent | Quanta System Spa |
| K192600 | Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60 | Feb 21, 2020 | Substantially Equivalent | quanta system spa |
| K192617 | Gemini 810+980 Soft Tissue Laser | Feb 20, 2020 | Substantially Equivalent | Azena Medical, LLC |
| K192583 | PicoLazer Laser System | Jan 17, 2020 | Substantially Equivalent | Rohrer Aesthetics, LLC |
| K193500 | Stellar M22 for Intense Pulsed Light (IPL) and Laser System | Jan 16, 2020 | Substantially Equivalent | Lumenis Ltd. |
| K193478 | XTRAC Momentum Excimer Laser System | Jan 14, 2020 | Substantially Equivalent | Strata Skin Sciences, Inc. |
| K193375 | NeuroBlate System | Jan 03, 2020 | Substantially Equivalent | Monteris Medical |
| K191501 | PALLAS 308/311 Solid-State UV Laser System | Jan 03, 2020 | Substantially Equivalent | Laseroptek Co., Ltd. |
| K192990 | Litho Evo | Dec 20, 2019 | Substantially Equivalent | Quanta System spa |
| K192755 | Soli-Lite LG4 Galileo | Dec 20, 2019 | Substantially Equivalent | Silhouet-Tone Corporation |
| K192539 | Deka Luxea | Dec 16, 2019 | Substantially Equivalent | El..EN. Electronic Engineering SPA |
| K192569 | Diode Laser Therapy System | Dec 13, 2019 | Substantially Equivalent | San He Lefis Electronics Co., Ltd. |
| K192516 | Diode Laser 808nm | Dec 10, 2019 | Substantially Equivalent | Beijing Superlaser Technology Co., Ltd. |
| K191962 | Vitra 2 | Dec 05, 2019 | Substantially Equivalent | Quantel Medical |
| K192430 | Epic 980 | Dec 04, 2019 | Substantially Equivalent | Biolase, Inc. |
| K192528 | CO2 Laser Therapy System | Dec 03, 2019 | Substantially Equivalent | Shangdong Huamei Technology Co., Ltd. |
| K192269 | TwinScan 808/755 Laser System | Nov 19, 2019 | Substantially Equivalent | GME German Medical Engineering GmbH |
| K192331 | LaseMD LEO Laser System | Nov 12, 2019 | Substantially Equivalent | Lutronic Global |
| K191693 | BC-5 | Nov 01, 2019 | Substantially Equivalent | Reveallux, Corp |
| K191942 | MT One Diamond | Oct 17, 2019 | Substantially Equivalent | M&T Srl |
| K190319 | Waterlase Laser System Family | Oct 10, 2019 | Substantially Equivalent | Biolase, Inc. |
| K191842 | Discovery Pico, Discovery Pico Plus, Discovery Pico Derm | Sep 17, 2019 | Substantially Equivalent | Quanta System, S.p.A. |
| K191685 | PicoWay Laser System | Sep 16, 2019 | Substantially Equivalent | Candela Corporation |
| K191518 | CO2 Laser System | Sep 12, 2019 | Substantially Equivalent | Shenzhen GSD Tech Co., Ltd |
| K181614 | Sterling Supreme Diode Laser | Sep 10, 2019 | Substantially Equivalent | CAO Group, Inc. |
| K181602 | Pioneer Elite Diode Laser | Sep 10, 2019 | Substantially Equivalent | CAO Group, Inc. |
| K181601 | Precise SHP Diode Laser | Sep 09, 2019 | Substantially Equivalent | CAO Group, Inc. |
| K192160 | EVO Platform | Sep 06, 2019 | Substantially Equivalent | Quanta System, S.p.A |
| K183563 | Holinwon 30 | Sep 05, 2019 | Substantially Equivalent | Won Tech Co., Ltd. |
| K191554 | LightWalker Laser System Family | Aug 30, 2019 | Substantially Equivalent | Fotona d.o.o. |
| K183122 | 810nm Diode Laser System | Aug 25, 2019 | Substantially Equivalent | Shanghai Wonderful Opto-Electrics Tech. Co., Ltd |
| K191349 | 980nm Diode Laser Therapy Device | Aug 16, 2019 | Substantially Equivalent | Shanghai Apolo Medical Technology Co., Ltd. |
| K183647 | SOLTIVE Laser System(SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVELaser Fibers, and Accessories) | Aug 09, 2019 | Substantially Equivalent | Olympus Surgical Technologies America |
| K191321 | Primelase Excellence | Aug 02, 2019 | Substantially Equivalent | High Technology Products SLU |
| K191611 | Diode Laser Therapy Systems | Jul 31, 2019 | Substantially Equivalent | Wingderm Electro-Optics Ltd. |
| K182930 | PerioLase Nd:YAG Pulsed Dental Laser System | Jul 12, 2019 | Substantially Equivalent | Millennium Dental Technologies, Inc. |
| K191162 | EpiLaze Multi-wavelength Laser | Jul 09, 2019 | Substantially Equivalent | Rohrer Aesthetics, LLC |
| K190938 | Phototherapy System | Jun 26, 2019 | Substantially Equivalent | Shanghai Apolo Medical Technology Co., Ltd. |
| K190936 | Q-Switched Nd: YAG Laser System | Jun 17, 2019 | Substantially Equivalent | Shanghai Apolo Medical Technology Co., Ltd. |
| K183566 | CLARITY II Laser System | Jun 14, 2019 | Substantially Equivalent | Lutronic Corporation |
| K190542 | Soliton Acoustic Wave Device | May 24, 2019 | Substantially Equivalent | Soliton Inc. |
| K183199 | TRIO Handpiece | May 02, 2019 | Substantially Equivalent | OmniGuide, Inc. |
| K183156 | V-Laser | Apr 24, 2019 | Substantially Equivalent | WONTECH Co., Ltd. |
| K182924 | Diode Laser Treatment System | Apr 15, 2019 | Substantially Equivalent | Weifang KM Electronics Co., LTD |
| K190392 | WaveLight FS200 Patient Interface | Mar 26, 2019 | Substantially Equivalent | Alcon Laboratories, Inc. |
| K182173 | Joule System | Mar 06, 2019 | Substantially Equivalent | Sciton, Inc |
| K190007 | Vydence Laser Family | Mar 01, 2019 | Substantially Equivalent | Vydence Medical Industria E Comercio Ltda |
| K183452 | Vbeam Prima Laser System | Feb 01, 2019 | Substantially Equivalent | Candela Corp. |
| K183392 | PicoLO Nd:YAG Picosecond Laser System | Jan 04, 2019 | Substantially Equivalent | Laseroptek Co., Ltd. |
| K182045 | Lotus III Multi-Pulsed Er: Yag Laser System | Dec 27, 2018 | Substantially Equivalent | Laseroptek Co., Ltd. |
| K182997 | enlighten III Laser System | Dec 12, 2018 | Substantially Equivalent | Cutera, Inc. |
| K183307 | Magma Spark Pro (Magma Spark Plus, Alpha) | Dec 11, 2018 | Substantially Equivalent | Formatk Systems Ltd. |
| K182831 | SabreLine and SabreGuard Laser Fibers | Dec 10, 2018 | Substantially Equivalent | Coloplast Corp |
| K182663 | Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System | Nov 30, 2018 | Substantially Equivalent | FineMEC Co., Ltd. |
| K182604 | New Era | Nov 14, 2018 | Substantially Equivalent | Step Up Skin Laser, LLC |
| K182270 | Cellene CO2 Laser System | Nov 02, 2018 | Substantially Equivalent | Bio-Med USA Inc. |
| K182088 | XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro | Oct 31, 2018 | Substantially Equivalent | Fotona d.o.o. |
| K182669 | Youlaser CO2 | Oct 17, 2018 | Substantially Equivalent | Quanta System SpA |
| K182036 | NeuroBlate System | Oct 15, 2018 | Substantially Equivalent | Monteris Medical |
| K181867 | Deka Smartxide2 Trio | Oct 02, 2018 | Substantially Equivalent | El.En Electronic Engineering Spa |
| K181632 | Venacure 1470 Pro | Sep 17, 2018 | Substantially Equivalent | Quanta System Spa |
| K173827 | LightScalpel | Sep 14, 2018 | Substantially Equivalent | LightScalpel LLC |
| K173676 | A-FIT | Sep 14, 2018 | Substantially Equivalent | HIRONIC Co., Ltd. |
| K181662 | Iridex TruFocus LIO Premiere | Sep 05, 2018 | Substantially Equivalent | Iridex Corporation |
| K181510 | ECHOLASER X4 | Sep 04, 2018 | Substantially Equivalent | El.En Electronic Engineering Spa |
| K181486 | DEKA Motus AY | Aug 30, 2018 | Substantially Equivalent | Elen Electronic Engineering Spa |
| K181480 | MMD Tip | Aug 01, 2018 | Substantially Equivalent | Strata Skin Sciences, Inc. |
| K181272 | Picocare Family | Jul 31, 2018 | Substantially Equivalent | WON TECH Co., Ltd. |
| K181431 | Laser Ureteral Catheter | Jul 30, 2018 | Substantially Equivalent | Cook Incorporated |
| K180518 | GME LinScan Lite 808 Laser System | Jul 23, 2018 | Substantially Equivalent | GME German Medical Engineering GmbH |
| K181019 | Diode Laser System | Jul 16, 2018 | Substantially Equivalent | Guangzhou Huafei Tongda Technology Co., Ltd. |
| K181523 | Syneron CO2RE System | Jul 11, 2018 | Substantially Equivalent | Syneron-Candela Corp |
| K180967 | Dental Diode Laser System | Jul 11, 2018 | Substantially Equivalent | Lazon Medical Laser Co., Ltd. |
| K181044 | 400um Perforator and Accessory Vein Ablation Kit | Jul 05, 2018 | Substantially Equivalent | AngioDynamics, Inc. |
| K173359 | Fractional CO2 Surgical Laser System | Jul 05, 2018 | Substantially Equivalent | AMI Inc. |
| K180993 | Beacon Advanced CO2 Laser System | Jun 28, 2018 | Substantially Equivalent | OmniGuide, Inc |
| K173700 | PICOPLUS Laser System | Jun 19, 2018 | Substantially Equivalent | Lutronic Corporation |
| K180719 | InMode Diolaze System | Jun 14, 2018 | Substantially Equivalent | InMode MD Ltd. |
| K180593 | Vbeam Prima Laser System | Jun 05, 2018 | Substantially Equivalent | Syneron-Candela |
| K180508 | JOULE SYSTEM | May 18, 2018 | Substantially Equivalent | Sciton, Inc. |
| K180922 | Empower H100, Cyber Ho 100, Litho 100 | May 08, 2018 | Substantially Equivalent | quanta system spa |
| K180140 | ProFlex Laser Fibers | Apr 20, 2018 | Substantially Equivalent | InnovaQuartz LLC |
| K171443 | Etherea MX | Apr 20, 2018 | Substantially Equivalent | Vydence Medical Industria E Comercio Ltda |
| K180353 | Diode laser hair removal device | Apr 17, 2018 | Substantially Equivalent | Zhengzhou PZ Laser Slim Technology Co., Ltd |
| K180597 | AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO | Apr 03, 2018 | Substantially Equivalent | Lumenis Ltd. |
| K180426 | Empower H35 | Mar 16, 2018 | Substantially Equivalent | Quanta System Spa |
| K180423 | Empower H65 | Mar 15, 2018 | Substantially Equivalent | quanta system spa |
| K180406 | Ellipse Ydun | Mar 15, 2018 | Substantially Equivalent | Ellipse A/S |
| K180224 | ELEMENT-TL | Mar 15, 2018 | Substantially Equivalent | Elemenic Co., Ltd. |
| K180044 | SIROLaser Blue | Mar 08, 2018 | Substantially Equivalent | Dentsply Sirona |
| K180350 | Dornier Medilas H Solvo 35 Laser | Mar 07, 2018 | Substantially Equivalent | Dornier MedTech America |
| K172818 | LMT-3000 | Mar 07, 2018 | Substantially Equivalent | Lameditech Co., Ltd. |
| K173677 | InMode VLaze | Feb 23, 2018 | Substantially Equivalent | InMode MD Ltd. |
| K173067 | LightForce LTS Model 1000, 1500, 2500, and 4000 | Feb 22, 2018 | Substantially Equivalent | LiteCure, LLC |
| K180193 | DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto) | Feb 21, 2018 | Substantially Equivalent | El.En Electronic Engineering S.p.A. |
| K180158 | Surgical Laser fibers | Feb 14, 2018 | Substantially Equivalent | Quanta System SPA |
| K172439 | Siberian Fit | Feb 14, 2018 | Substantially Equivalent | Vydence |
| K173199 | PicoSure Workstation | Feb 07, 2018 | Substantially Equivalent | Cynosure, Inc |
| K173285 | JOULE SYSTEM | Jan 29, 2018 | Substantially Equivalent | Sciton, Inc |
| K172193 | Modified Alma Lasers Soprano XL Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules | Jan 09, 2018 | Substantially Equivalent | Alma Lasers Inc. |
| K173002 | 2940 nm Er:Yag Laser Handpiece | Dec 13, 2017 | Substantially Equivalent | Quanta System S.p.A. |
| K172908 | Q-Switched Nd:YAG Laser System | Dec 07, 2017 | Substantially Equivalent | AMI Inc. |
| K173038 | CuRAS Nd:YAG Laser | Dec 01, 2017 | Substantially Equivalent | Ilooda Co., Ltd. |
| K172819 | LightWalker Laser System Family | Dec 01, 2017 | Substantially Equivalent | Fotona d.o.o. |
| K172771 | Epic Pro 940 | Nov 29, 2017 | Substantially Equivalent | Biolase, Inc |
| K173169 | Rapid Family | Nov 20, 2017 | Substantially Equivalent | SharpLight Technologies Ltd. |
| K173305 | NeuroBlate System | Nov 17, 2017 | Substantially Equivalent | Monteris Medical, |
| K172363 | DEKA SMARTXIDE ULTRASPEED | Nov 17, 2017 | Substantially Equivalent | EL.EN. Electronic Engineering Spa |
| K172362 | DEKA SMARTXIDE TOUCH | Nov 17, 2017 | Substantially Equivalent | EL.EN Electronic Engineering Spa |
| K172639 | PALLAS 308/311 Solid-State UV Laser System | Nov 03, 2017 | Substantially Equivalent | Laseroptek Co.Ltd |
| K172077 | Cutera enlighten III Laser System | Oct 27, 2017 | Substantially Equivalent | Cutera, Inc. |
| K172325 | Rhapsody H-30 Holmium Laser System | Oct 26, 2017 | Substantially Equivalent | Cook Incorporated |
| K172881 | NeuroBlate System | Oct 20, 2017 | Substantially Equivalent | Monteris Medical |
| K172376 | Discovery Pico, Discovery Pico Plus | Oct 19, 2017 | Substantially Equivalent | Quanta System S.p.A. |
| K172198 | 585 | Oct 17, 2017 | Substantially Equivalent | Quanta System S.p.A. |
| K172413 | MT ONE | Oct 06, 2017 | Substantially Equivalent | M&T S.R.L |
| K171986 | Sterling Supreme Diode Laser | Sep 22, 2017 | Substantially Equivalent | CAO Group, Inc. |
| K170179 | LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity | Sep 18, 2017 | Substantially Equivalent | Lumenis Ltd. |
| K170409 | PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System | Sep 12, 2017 | Substantially Equivalent | Topcon Medical Laser Systems, Inc. (TMLS) |
| K171648 | BM.IRIS | Sep 08, 2017 | Substantially Equivalent | Bluecore Co.,Ltd. |
| K170970 | Epilaser | Sep 01, 2017 | Substantially Equivalent | Epilady 2000 LLC |
| K171921 | VenaCure EVLT NeverTouch Procedure Kit | Aug 24, 2017 | Substantially Equivalent | AngioDynamics, Inc. |
| K171227 | StarWalker | Aug 18, 2017 | Substantially Equivalent | Fotona d.o.o. |
| K172096 | Fraxis | Aug 09, 2017 | Substantially Equivalent | Ilooda Co. LTD |
| K170060 | M22 and ResurFx Systems | Aug 09, 2017 | Substantially Equivalent | LUMENIS, LTD. |
| K170738 | InMode Diolaze XL | Aug 07, 2017 | Substantially Equivalent | InMode MD Ltd. |
| K171079 | Q-Switched Nd:YAG Laser System | Aug 01, 2017 | Substantially Equivalent | IDS, Ltd. |
| K172025 | Litho 60 | Jul 31, 2017 | Substantially Equivalent | quanta system spa |
| K171945 | Discovery Pico, Discovery Pico Plus | Jul 28, 2017 | Substantially Equivalent | Quanta System S.p.A. |
| K170187 | Photodynamic Therapy Device | Jul 28, 2017 | Substantially Equivalent | UVBIOTEK, LLC |
| K171255 | Monteris Medical NeuroBlate System | Jul 25, 2017 | Substantially Equivalent | Monteris Medical, Inc. |
| K170073 | LightMed Dental Laser System | Jul 25, 2017 | Substantially Equivalent | LIGHTMED DENTALTECHNOLOGY CORP. |
| K171711 | Thunder, Thunder VT, Thunder HR | Jul 07, 2017 | Substantially Equivalent | Quanta System S.p.A. |
| K171009 | LASEMD Laser System | Jun 23, 2017 | Substantially Equivalent | Lutronic Corporation |
| K163449 | HyPHo Laser System | Jun 23, 2017 | Substantially Equivalent | Hyper Photonics SRL |
| K162886 | DEKA MOTUS AX | Jun 19, 2017 | Substantially Equivalent | EL.EN. ELECTRONIC ENGINEERING SPA |
| K162659 | Diode Laser Hair Removal System | Jun 16, 2017 | Substantially Equivalent | SHANDONG HUAMEI TECHNOLOGY CO.,LTD. |
| K170850 | Alma Q | Jun 15, 2017 | Substantially Equivalent | Alma Lasers LTD |
| K162755 | Picocare | Jun 12, 2017 | Substantially Equivalent | WON TECH CO., LTD. |
| K170366 | Laser Peripherals, LLC Family of Bare Laser Fibers | Jun 08, 2017 | Substantially Equivalent | Laser Peripherals, LLC |
| K170626 | Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece | May 31, 2017 | Substantially Equivalent | Alma Lasers Inc. |
| K170597 | PicoWay Laser System | May 25, 2017 | Substantially Equivalent | Syneron Candela Corporation |
| K163197 | Cook Holmium Laser Fiber | May 24, 2017 | Substantially Equivalent | COOK INCORPORATED |
| K163196 | ACTION II Laser System | May 24, 2017 | Substantially Equivalent | LUTRONIC CORPORATION |
| K170121 | Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories | May 22, 2017 | Substantially Equivalent | Lumenis Ltd. |
| K160677 | MICRORUPTOR 6 | May 19, 2017 | Substantially Equivalent | MERIDIAN AG |
| K170500 | SIROLaser Advance+ | May 16, 2017 | Substantially Equivalent | Dentsply Sirona |
| K163638 | Dental 5 Multi Diode laser | May 15, 2017 | Substantially Equivalent | BIO-MED USA INC |
| K170734 | Venus Silk.expert | May 08, 2017 | Substantially Equivalent | Cyden Limited |
| K170718 | Iridex TruFocus LIO Premiere | May 03, 2017 | Substantially Equivalent | Iridex Corporation |
| K162334 | U.S. Laser Worx Patriot 1 family of lasers | Apr 27, 2017 | Substantially Equivalent | U.S. Laser Worx |
| K170936 | Cutera enlighten III Laser System | Apr 25, 2017 | Substantially Equivalent | Cutera, Inc. |
| K170215 | LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDock | Apr 19, 2017 | Substantially Equivalent | Patient Pocket LLC |
| K170724 | NeuroBlate System | Apr 07, 2017 | Substantially Equivalent | Monteris Medical |
| K160549 | MEDICAL DIODE LASER SYSTEMS | Apr 07, 2017 | Substantially Equivalent | WUHAN GIGAA OPTRONICS TECHNOLOGY CO., LTD |
| K161257 | MultiPulse HoPLUS | Mar 31, 2017 | Substantially Equivalent | ASCLEPION LASER TECHNOLOGIES GMBH |
| K162556 | LIGHTFUSION LED SYSTEM | Mar 24, 2017 | Substantially Equivalent | VITAGE LED LTD |
| K163103 | Tranberg CLS Diffusor Laser Fiber | Mar 23, 2017 | Substantially Equivalent | Clinical Laserthermia Systems AB |
| K163655 | Sparkling | Mar 17, 2017 | Substantially Equivalent | Shanghai Wonderful Opto-Electrics Tech. Co., Ltd |
| K170331 | Cyber Ho | Mar 03, 2017 | Substantially Equivalent | quanta system spa |
| K162837 | Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532 Laser System | Feb 28, 2017 | Substantially Equivalent | LUMENIS LTD |
| K161926 | ND YAG Q-switch Laser Therapy Machine | Feb 22, 2017 | Substantially Equivalent | Beijing ADSS Development Co., Ltd |
| K163123 | Q-Switched Nd:YAG Laser Therapy Systems | Feb 02, 2017 | Substantially Equivalent | BEIJING SINCOHEREN SCIENCE AND TECHNOLOGY DEVELOPMENT CO. |
| K162454 | PicoWay Laser System | Feb 01, 2017 | Substantially Equivalent | SYNERON CANDELA CORPORATION |
| K162851 | eLyx-PRO | Jan 24, 2017 | Substantially Equivalent | Intelligent Sensory Concept SA |
| K163128 | Epic Pro | Jan 11, 2017 | Substantially Equivalent | Biolase, Inc |
| K162765 | Venus Velocity Diode Laser System | Jan 11, 2017 | Substantially Equivalent | Venus Concept Ltd. |
| K162114 | Photon, Photon Plus | Dec 12, 2016 | Substantially Equivalent | Zolar Technology & MFG Co. Inc. |
| K161632 | FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag) | Dec 08, 2016 | Substantially Equivalent | BIOS S.R.L. |
| K163222 | Discovery Pico Family | Dec 05, 2016 | Substantially Equivalent | Quanta System Spa |
| K163009 | Litho | Dec 01, 2016 | Substantially Equivalent | Quanta System SpA |
| K162191 | NAVILAS Laser System | Nov 22, 2016 | Substantially Equivalent | OD-OS GMBH |
| K162363 | V30 system, V-Form Handpiece BC Medium applicator | Nov 18, 2016 | Substantially Equivalent | Viora Ltd. |
| K162914 | VenaCure EVLT NeverTouch Procedure Kit | Nov 16, 2016 | Substantially Equivalent | AngioDynamics, Inc. |
| K161692 | Diode Laser Therapy Machine | Nov 16, 2016 | Substantially Equivalent | BEIJING ADSS DEVELOPMENT CO., LTD |
| K162781 | Magma Spark | Nov 09, 2016 | Substantially Equivalent | Formatk Systems Ltd. |
| K161670 | Lucid Q-PTP / HWA 55 | Nov 02, 2016 | Substantially Equivalent | BISON MEDICAL CO., LTD |
| K160488 | Cutera enlighten III Laser System | Oct 28, 2016 | Substantially Equivalent | Cutera, Inc. |
| K160312 | FRAXIS DUO | Oct 28, 2016 | Substantially Equivalent | ILOODA CO., LTD |
| K162169 | EdgeOne CO2 Laser | Oct 27, 2016 | Substantially Equivalent | Jeisys Medical Inc. |
| K162762 | NeuroBlate System | Oct 26, 2016 | Substantially Equivalent | Monteris Medical, Inc. |
| K161981 | Olive Plus | Oct 14, 2016 | Substantially Equivalent | AMA NETWORK INC |
| K161925 | CO2 Laser Therapy Machine | Oct 05, 2016 | Substantially Equivalent | Beijing ADSS Development Co., Ltd |
| K162416 | IRIDEX Cyclo G6 Laser System, G-Probe Illuminate | Sep 29, 2016 | Substantially Equivalent | IRIDEX CORPORATION |
| K161185 | LUCERNA Dental Laser | Sep 26, 2016 | Substantially Equivalent | VIAX DENTAL LAB |
| K160413 | Sterling 5W Diode Laser | Sep 21, 2016 | Substantially Equivalent | CAO Group, Inc. |
| K161162 | Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra | Sep 16, 2016 | Substantially Equivalent | ELLIPSE A/S |
| K161356 | Matrix LS-40 CO2 Laser System | Sep 09, 2016 | Substantially Equivalent | SHANGHAI WONDERFUL OPTO-ELECTRICS TECH. CO., LTD. |
| K161503 | ORION | Aug 26, 2016 | Substantially Equivalent | YERIM ENGINEERING Co., Ltd. |
| K161403 | A.R.C. Laser Surgical Fibers and Probes | Aug 16, 2016 | Substantially Equivalent | A.R.C. LASER GMBH |
| K161771 | Medilas H Laser Fibers | Jul 28, 2016 | Substantially Equivalent | DORNIER MEDTECH AMERICA, INC. |
| K161669 | Waterlase Express | Jul 28, 2016 | Substantially Equivalent | Biolase, Inc. |
| K153124 | DuraLazeTM HoLEP Laser Fiber | Jul 26, 2016 | Substantially Equivalent | MedKey, LLC |
| K160607 | PicoWay Laser System | Jul 05, 2016 | Substantially Equivalent | SYNERON CANDELA CORPORATION |
| K152737 | Lite Touch | Jun 29, 2016 | Substantially Equivalent | FOCUS MEDICAL LLC |
| K152667 | ATOVEN-Reusable Laser Fiber | Jun 09, 2016 | Substantially Equivalent | DIOTECH CO |
| K160012 | O-pel Laser and families of probe delivery devices | Jun 02, 2016 | Substantially Equivalent | PRECISE LIGHT SURGICAL |
| K152856 | Helios III | Jun 02, 2016 | Substantially Equivalent | LASEROPTEK CO. LTD. |
| K160480 | PicoSure Workstation | May 17, 2016 | Substantially Equivalent | Cynosure, Inc |
| K160952 | Alma Diode Tabletop Laser | May 05, 2016 | Substantially Equivalent | ALMA LTD |
| K160227 | ACCENTO / HWA Dual/Single laser | Apr 22, 2016 | Substantially Equivalent | BISON MEDICAL CO LTD |
| K151855 | SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral Firing Fiber | Apr 15, 2016 | Substantially Equivalent | SURGICAL LASER INCORPORATED |
| K153229 | Superbium | Apr 12, 2016 | Substantially Equivalent | BIOS S.R.L |
| K153566 | Magma System | Apr 06, 2016 | Substantially Equivalent | FORMATK SYSTEMS LTD. |
| K160368 | EVO platform | Apr 05, 2016 | Substantially Equivalent | Quanta System SpA |
| K153564 | PURE CRYOGEN | Mar 29, 2016 | Substantially Equivalent | AIR LIQUIDE HEALTHCARE AMERICA CORPORATION |
| K160513 | Quanta System Surgical Laser fibers | Mar 18, 2016 | Substantially Equivalent | QUANTA SYSTEM SPA |
| K151763 | PerioLase Nd:YAG Pulsed Dental Laser System | Mar 15, 2016 | Substantially Equivalent | MILLENNIUM DENTAL TECHNOLOGIES, INC. |
| K153671 | Family of CoolGlide Aesthetic Lasers | Mar 09, 2016 | Substantially Equivalent | CUTERA, INC. |
| K153527 | PicoWay Laser System | Mar 02, 2016 | Substantially Equivalent | SYNERON CANDELA CORPORATION |
| K160392 | Novilase Laser Therapy System, Model LTS-2 | Feb 26, 2016 | Substantially Equivalent | NOVIAN HEALTH, INC. |
| K152736 | SKIN CARE | Feb 25, 2016 | Substantially Equivalent | C.I.S LTD |
| K152611 | V20 system | Feb 19, 2016 | Substantially Equivalent | VIORA LTD. |
| K153718 | Spirit Hair Removal laser Family | Feb 12, 2016 | Substantially Equivalent | ACTIVE OPTICAL SYSTEMS , LTD. |
| K151569 | Tranberg CLS Laser Fiber | Feb 12, 2016 | Substantially Equivalent | Clinical Laserthermia Systems AB |
| K152898 | DIODE LASER THERAPY SYSTEMS | Feb 09, 2016 | Substantially Equivalent | BEIJING SINCOHEREN SCIENCE AND TECH. DEVELOPMENT CO., LTD |
| K152529 | NaturaLase CO2 Laser System | Feb 04, 2016 | Substantially Equivalent | FOCUS MEDICAL, LLC |
| K143713 | Lustre PRO Light System | Jan 19, 2016 | Substantially Equivalent | AMBICARE HEALTH LTD |
| K151890 | Medical Diode Laser Systems | Dec 23, 2015 | Substantially Equivalent | Wuhan Gigaa Optronics Technology Co., Ltd |
| K150997 | RUBY STAR | Dec 22, 2015 | Substantially Equivalent | BISON MEDICAL CO., LTD |
| K150664 | NeoLas | Dec 22, 2015 | Substantially Equivalent | SHEAUMANN LASER, INC |
| K152714 | Quanta Forte | Dec 21, 2015 | Substantially Equivalent | QUANTA SYSTEM SPA |
| K152636 | Laser Dock | Dec 17, 2015 | Substantially Equivalent | PATIENT POCKET, LLC |
| K152153 | MicroSpot Handpiece | Dec 11, 2015 | Substantially Equivalent | ASCLEPION LASER TECHNOLOGIES GMBH |
| K152722 | neoV980 & neoV1470 Diode Lasers | Dec 08, 2015 | Substantially Equivalent | G.N.S NEO LASER LTD. |
| K152012 | EVO platform | Dec 08, 2015 | Substantially Equivalent | Quanta System SpA |
| K152417 | Adler MicroMed Laser Surgery Fibers | Dec 01, 2015 | Substantially Equivalent | ADLER MICROMED INC. |
| K152939 | Picasso Plus, Picasso Lite Plus | Nov 25, 2015 | Substantially Equivalent | AMD GROUP LLC |
| K151109 | Lumenis Smart532 Laser System | Oct 30, 2015 | Substantially Equivalent | LUMENIS, INC. |
| K151629 | Guardian 1000 | Oct 27, 2015 | Substantially Equivalent | Quanta System SpA |
| K152591 | Medilas H RFID Laser Fibers | Oct 08, 2015 | Substantially Equivalent | Dornier MedTech America, Inc. |
| K151306 | Solea | Sep 23, 2015 | Substantially Equivalent | CONVERGENT DENTAL, INC |
| K152032 | ELUMI 810 + 980 Soft Tissue Laser | Sep 16, 2015 | Substantially Equivalent | AZENA MEDICAL, LLC |
| K151655 | CO2RE System | Sep 15, 2015 | Substantially Equivalent | SYNERON MEDICAL LTD. |
| K152220 | MH01 | Sep 03, 2015 | Substantially Equivalent | QUANTA SYSTEM SPA |
| K151473 | NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and Pulse Slicing Module | Sep 01, 2015 | Substantially Equivalent | FOCUS MEDICAL, LLC. |
| K151947 | LightSheer Desire Light Laser System | Aug 12, 2015 | Substantially Equivalent | LUMENIS LTD |
| K151232 | VIKINI Diode Laser System | Aug 06, 2015 | Substantially Equivalent | ILOODA CO., LTD |
| K150587 | Cortex Laser System | Jul 21, 2015 | Substantially Equivalent | Cynosure, Inc. dba Ellman |
| K150907 | Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra | Jul 07, 2015 | Substantially Equivalent | Ellipse A/S |
| K151331 | The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTouch | Jun 30, 2015 | Substantially Equivalent | LUMENIS LTD |
| K150140 | MCL 31 Dermablate | Jun 05, 2015 | Substantially Equivalent | ASCLEPION LASER TECHNOLOGIES GMBH |
| K140386 | LUMINA 24 | May 26, 2015 | Substantially Equivalent | ROGERS SCIENCES INC. |
| K143666 | Noblex Long Pulse Alexandrite Laser | Apr 23, 2015 | Substantially Equivalent | FINEMEC CO.,LTD. |
| K142216 | Tranberg CLS Thermal Therapy System | Apr 21, 2015 | Substantially Equivalent | Clinical Laserthermia Systems AB |
| K142186 | DIODE LASER HAIR REMOVAL SYSTEM | Apr 17, 2015 | Substantially Equivalent | SHENZHEN GSD TECH. CO., LTD. |
| K150326 | PicoWay Laser System | Apr 16, 2015 | Substantially Equivalent | Candela Corporation |
| K150516 | DEKA SYNCHRO REPLA:Y FAMILY OF LASER SYSTEMS | Apr 13, 2015 | Substantially Equivalent | EL.EN ELECTRONIC ENGINEERING SPA |
| K143723 | SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro | Apr 09, 2015 | Substantially Equivalent | FOTONA D.D. |
| K150027 | CYMA | Apr 03, 2015 | Substantially Equivalent | WhiteCap Technologies LLC |
| K133788 | COOK HOLMIUM LASER FIBER | Mar 18, 2015 | Substantially Equivalent | COOK INCORPORATED |
| K143519 | The MeDioStar NeXT Family | Mar 10, 2015 | Substantially Equivalent | ASCLEPION LASER TECHNOLOGIES GMBH |
| K141975 | WATERLASE IPLUS S | Mar 05, 2015 | Substantially Equivalent | BIOLASE, INC. |
| K150336 | Photonica Professional | Feb 24, 2015 | Substantially Equivalent | Ward Photonics LLC |
| K143105 | Picosure Workstation | Feb 23, 2015 | Substantially Equivalent | CYNOSURE, INC. |
| K143457 | NeuroBlate System | Feb 19, 2015 | Substantially Equivalent | MONTERIS MEDICAL, INC. |
| K142924 | Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System Family | Feb 13, 2015 | Substantially Equivalent | SHASER, INC. |
| K141986 | ELUX 810 LASER | Jan 30, 2015 | Substantially Equivalent | EQUIPMED NORTH AMERICA, INC. |
| K133891 | MULTIPULSE TM+1470 | Jan 30, 2015 | Substantially Equivalent | ASCLEPION LASER TECHNOLOGIES GMBH |
| K141511 | SIDELAZE800 LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440MM WAVELENGTH LASERS | Jan 23, 2015 | Substantially Equivalent | CYNOSURE, INC. |
| K142860 | Lumenis M22 System | Jan 21, 2015 | Substantially Equivalent | Lumenis Ltd. |
| K142952 | InMode Diolaze Device | Jan 13, 2015 | Substantially Equivalent | INMODE MD LTD. |
| K141852 | IFS ADVANCED FEMTOSECOND LASER SYSTEM | Jan 06, 2015 | Substantially Equivalent | AMO MANUFACTURING USA, LLC |
| K143154 | IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe(RFID) | Jan 02, 2015 | Substantially Equivalent | IRIDEX CORPORATION |
| K141851 | NAVILAS LASER SYSTEM | Jan 02, 2015 | Substantially Equivalent | OD -OS GMBH |
| K142638 | ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex 273) | Dec 19, 2014 | Substantially Equivalent | InnovaQuartz LLC |
| K142093 | V20 SYSTEM | Nov 14, 2014 | Substantially Equivalent | VIORA LTD. |
| K140732 | CANDELA GENTLELASE FAMILY OF LASER SYSTEMS | Nov 07, 2014 | Substantially Equivalent | CANDELA CORP. |
| K141555 | ADVANTAGE | Nov 06, 2014 | Substantially Equivalent | LUTRONIC CORPORATION |
| K140727 | CUTERA PICOSECOND LASER SYSTEM | Nov 06, 2014 | Substantially Equivalent | CUTERA, INC. |
| K142286 | NS3000 Holmium Laser System | Oct 31, 2014 | Substantially Equivalent | New Star Lasers, Inc. |
| K142372 | Pico Way Laser System | Oct 30, 2014 | Substantially Equivalent | CANDELA CORPATION |
| K141908 | DUAL SWITCH | Oct 22, 2014 | Substantially Equivalent | LASER ENGINEERING, INC. |
| K141658 | LIGHT SCALPEL | Oct 22, 2014 | Substantially Equivalent | LIGHT SCALPEL LLC |
| K140470 | OBERON: LASER SURGERY FIBER, ATRAUMATIC SURGERY FIBER, SIDE FIRE FIBER, RADIAL EMISSION FIBER, DENTAL SURGERY FIBER | Oct 15, 2014 | Substantially Equivalent | OBERON GMBH FIBER TECHNOLOGIES |
| K131987 | MULTIPULSE HOPLUS | Oct 15, 2014 | Substantially Equivalent | ASCLEPION LASER TECHNOLOGIES GMBH |
| K142614 | AngioDynamics VenaCure EVLT Tre Sheath and VenaCure EVLT NeverTouch Procedure Kits | Oct 10, 2014 | Substantially Equivalent | AngioDynamics, Inc. |
| K140120 | EPIC 10 | Oct 10, 2014 | Substantially Equivalent | BIOLASE, INC. |
| K140249 | LONG PULSE ND: YAG LASER SYSTEM | Oct 08, 2014 | Substantially Equivalent | ADVANCED TECHNOLOGY LASER CO., LTD. |
| K141973 | DIODE LASER HAIR REMOVAL SYSTEM | Oct 06, 2014 | Substantially Equivalent | BEIJING ANCHORFREE TECHNOLOGY CO., LTD |
| K140378 | FLEXGUIDE ULTRA BEAMPATH ROBOTIC FIBER CONDUIT | Sep 25, 2014 | Substantially Equivalent | OMNIGUIDE, INC. |
| K142376 | Palomar Icon Aesthetic System | Sep 24, 2014 | Substantially Equivalent | CYNOSURE, INC. |
| K140837 | LUCID LY | Sep 24, 2014 | Substantially Equivalent | BIO-MED USA INC. |
| K140719 | PICOSURE WORKSTATION | Sep 22, 2014 | Substantially Equivalent | CYNOSURE, INC. |
| K142226 | Pilot Ultra Diode Laser | Sep 12, 2014 | Substantially Equivalent | CAO GROUP, INC. |
| K142225 | Pilot Elite Diode Laser | Sep 12, 2014 | Substantially Equivalent | CAO Group, Inc. |
| K142223 | Pilot Pro Diode Laser | Sep 12, 2014 | Substantially Equivalent | CAO GROUP, INC. |
| K141425 | ELITE + LASER SYSTEM | Sep 11, 2014 | Substantially Equivalent | CYNOSURE, INC. |
| K133895 | DEKA SMARTXIDE LASER SYSTEM | Sep 05, 2014 | Substantially Equivalent | EL.EN. S.P.A |
| K140964 | CALCULASE II | Sep 04, 2014 | Substantially Equivalent | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| K140009 | SOPRANO ICE MULTI-APPLICATION & MULTI-TECHNOLOGY PLATFORM | Aug 29, 2014 | Substantially Equivalent | ALMA LASERS LTD. |
| K140458 | DIOTECH LASER FIBER | Aug 26, 2014 | Substantially Equivalent | DIOTECH CO |
| K140366 | ENDLESSFIBER REUSABLE SURGICAL LASER FIBER | Aug 15, 2014 | Substantially Equivalent | HOGUE SURGICAL LLC |
| K141983 | NEUROBLATE SYSTEM | Aug 11, 2014 | Substantially Equivalent | MONTERIS MEDICAL CORP |
| K133945 | CUTERA PICOSECOND LASER SYSTEM | Aug 11, 2014 | Substantially Equivalent | CUTERA, INC. |
| K141101 | LITHO | Aug 08, 2014 | Substantially Equivalent | QUANTA SYSTEM, S.P.A. |
| K141403 | LITHO DK30 | Aug 07, 2014 | Substantially Equivalent | QUANTA SYSTEM, S.P.A. |
| K141838 | SOL PORTABLE DIODE LASER UNIT (WITH WIRELESS FOOT CONTROL) | Jul 25, 2014 | Substantially Equivalent | REGULATORY TECHNOLOGY SERVICES, LLC |
| K133364 | PICOSURE WORKSTATION | Jul 22, 2014 | Substantially Equivalent | CYNOSURE, INC. |
| K140005 | ALMA DIODE TABLETOP LASER | Jul 18, 2014 | Substantially Equivalent | ALMA LASERS LTD. |
| K131757 | TATTOOSTAR EFFECT COMBO | Jul 17, 2014 | Substantially Equivalent | ASCLEPION LASER TECHNOLOGIES GMBH |
| K141063 | LINSCAN 808, LINSCAN 980 | Jul 15, 2014 | Substantially Equivalent | GME (GERMAN MEDICAL ENGINEERING) GMBH |
| K132806 | FOTONA F-22 LASER HANDPIECE (F-RUNNER), FOTONA FS-01 LASER HANDPIECE | Jul 11, 2014 | Substantially Equivalent | FOTONA D.D. |
| K140679 | SUREFLEX LITHOTRIPSY LASER FIBERS | Jun 20, 2014 | Substantially Equivalent | AMERICAN MEDICAL SYSTEMS |
| K133297 | QUADROSTARPROGREEN, QUADROSTARPROYELLOW | Jun 10, 2014 | Substantially Equivalent | ASCLEPION LASER TECHNOLOGIES GMBH |
| K133774 | ATOVEN | Jun 06, 2014 | Substantially Equivalent | BIO-MED U.S.A., INC. |
| K140122 | CANDELA GENTLEMAX FAMILY OF LASER SYSTEM | May 09, 2014 | Substantially Equivalent | CANDELA CORP. |
| K131838 | DIODE LASER FOR HIAR REMOVAL | Apr 24, 2014 | Substantially Equivalent | BEIJING HONKON TECHNOLOGIES CO., LTD |
| K133915 | GALAXY CO2 LASER SYSTEM | Apr 18, 2014 | Substantially Equivalent | BEIJING TOPLASER TECHNOLOGY CO., LTD. |
| K133006 | NEOV DIODE LASER FAMILY | Apr 17, 2014 | Substantially Equivalent | G.N.S NEOLASER LTD. |
| K132976 | ADVATX | Apr 17, 2014 | Substantially Equivalent | ADVALIGHT APS |
| K140503 | FLEXIVA SF SIDE-FIRING SINGLE-USE LASER FIBER | Apr 15, 2014 | Substantially Equivalent | BOSTON SCIENTIFIC |
| K133837 | VIORA V-TOTAL | Apr 09, 2014 | Substantially Equivalent | VIORA LTD. |
| K132607 | NS 2500 HOLMIUM LASER SYSTEM | Mar 21, 2014 | Substantially Equivalent | NEW STAR LASERS, INC. |
| K133319 | ET LIGHTSHEER 1060, HIGH SPEED LIGHTSHEER 1060 | Mar 20, 2014 | Substantially Equivalent | LUMENIS LTD. |
| K132975 | SPHINX JR | Mar 18, 2014 | Substantially Equivalent | ALLMED SYSTEMS INC. |
| K140388 | LUMENIS PULSE 120H | Mar 14, 2014 | Substantially Equivalent | LUMENIS LTD. |
| K122358 | NOVEON | Mar 11, 2014 | Substantially Equivalent | HOGAN LOVELLS US, L.L.P. |
| K133254 | REVLITE Q-SWITCHED ND:YAG LASER SYSTEM | Mar 05, 2014 | Substantially Equivalent | CYNOSURE, INC. |
| K133158 | ND: YAG LASER SYSTEM | Feb 28, 2014 | Substantially Equivalent | BEIJING TOPLASER TECHNOLOGY CO., LTD. |
| K132989 | SPEED 808 DIODE LASER SYSTEM | Jan 23, 2014 | Substantially Equivalent | BEIJING TOPLASER TECHNOLOGY CO., LTD. |
| K132286 | HYPERION LONG PULSED ND: YAG LASER | Jan 22, 2014 | Substantially Equivalent | SCARLET RF, INC |
| K131837 | CO2 FRACTIONAL LASER | Jan 22, 2014 | Substantially Equivalent | BEIJING HONKON TECHNOLOGIES CO., LTD |
| K131857 | Q-SWITCHED ND:YAG LASER | Jan 16, 2014 | Substantially Equivalent | BEIJING HONKON TECHNOLOGIES CO., LTD |
| K130681 | ENDOVASCULAR LASER VENOUS SYSTEM KIT WITH 2 RING RADIAL EMITTING FIBER | Jan 08, 2014 | Substantially Equivalent | BIOLITEC SIA |
| K132661 | LIGHTSCALPEL | Jan 02, 2014 | Substantially Equivalent | LIGHTSCALPEL LLC |
| K133283 | CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS | Dec 26, 2013 | Substantially Equivalent | CANDELA CORP. |
| K133561 | VENACURE EVLT NEVERTOUCH PROCEDURE KIT, VENACURE EVLT TRE' SHEATH | Dec 19, 2013 | Substantially Equivalent | ANGIODYNAMICS, INC. |
| K132185 | FAMILY OF COOLGLIDE AESTHETIC LASERS | Dec 06, 2013 | Substantially Equivalent | CUTERA, INC. |
| K131095 | DEKA SYNCHRO REPLA: Y FAMILY OF LASER SYSTEMS | Dec 05, 2013 | Substantially Equivalent | EL.EN. ELECTRONIC ENGINEERING SPA |
| K131142 | GENESIS LED WANDS | Nov 27, 2013 | Substantially Equivalent | GENESIS BIOSYSTEMS, INC. |
| K130199 | CLARITY LPC LASER SYSTEM | Nov 22, 2013 | Substantially Equivalent | LUTRONIC CORPORATION |
| K131839 | DC 7 | Nov 07, 2013 | Substantially Equivalent | DC INTERNATIONAL, LLC |
| K131894 | NIDEK GREEN LASER PHOTOCOAGULTOR MODEL GYC-1000 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT | Oct 31, 2013 | Substantially Equivalent | NIDEK CO., LTD. |
| K131473 | (QUANTA SYSTEM) SURGICAL LASER FIBERS | Oct 24, 2013 | Substantially Equivalent | QUANTA SYSTEM, S.P.A. |
| K131059 | PIONEER ELITE DIODE LASER | Sep 13, 2013 | Substantially Equivalent | CAO GROUP, INC. |
| K123443 | PRECISE SHP DIODE LASER | Aug 13, 2013 | Substantially Equivalent | CAO GROUP, INC. |
| K131955 | NEUROBLATE(TM) SYSTEM | Jul 30, 2013 | Substantially Equivalent | MONTERIS MEDICAL, INC. |
| K131805 | INPULSE LASER | Jul 18, 2013 | Substantially Equivalent | INCISIVE INC. |
| K130420 | SOLEA | Jul 12, 2013 | Substantially Equivalent | CONVERGENT DENTAL, INC |
| K131278 | MONTERIS MEDICAL NEUROBLATE SYSTEM | Jul 11, 2013 | Substantially Equivalent | MONTERIS MEDICAL, INC. |
| K131081 | CYBER TM FAMILY | Jul 03, 2013 | Substantially Equivalent | Quanta System SpA |
| K130256 | MDK MULTI-APPLICATIONS PLATFORM | Jul 02, 2013 | Substantially Equivalent | Quanta System SpA |
| K124030 | COOK HOLMIUM LASER FIBER | Jul 01, 2013 | Substantially Equivalent | COOK INCORPORATED |
| K122567 | JOULE 810/940/980 MULTI-PLATFORM SYSTEM | Jun 19, 2013 | Substantially Equivalent | SCITON, INC. |
| K130193 | FRAXEL DUAL 1550/1927 LASER SYSTEM | Jun 14, 2013 | Substantially Equivalent | SOLTA MEDICAL, INC. |
| K122020 | PHOTON PHOTON PLUS | Jun 05, 2013 | Substantially Equivalent | ZOLAR TECHNOLOGY & MFG. CO. INC. |
| K130444 | H-30 HOLMIUM LASER SYSTEM | May 22, 2013 | Substantially Equivalent | COOK, INC. |
| K122493 | GENESISPLUS | May 15, 2013 | Substantially Equivalent | CUTERA, INC. |
| K130250 | QYAG LASER SYSTEM | May 03, 2013 | Substantially Equivalent | PALOMAR MEDICAL TECHNOLOGIES, INC. |
| K122368 | WATERLASE IPLUS ALL TISSUE LASER | May 02, 2013 | Substantially Equivalent | BIOLASE TECHNOLOGY, INC. |
| K123483 | DIODE LASER | Apr 21, 2013 | Substantially Equivalent | BEIJING SYNTECH LASER CO., LTD. |
| K123573 | YOULASER CO2 LASER | Apr 15, 2013 | Substantially Equivalent | QUANTA SYSTEM, S.P.A. |
| K130465 | EPIC 10S | Apr 11, 2013 | Substantially Equivalent | BIOLASE TECHNOLOGY, INC. |
| K123777 | MULTILASER SYSTEM | Apr 11, 2013 | Substantially Equivalent | ULTRALIGHT LASER TECHNOLOGIES, LLC |
| K123293 | PASTELLE Q-SWITCHED ND: YAG LASER | Apr 11, 2013 | Substantially Equivalent | WON TECHNOLOGY CO., LTD. |
| K120561 | NEUROBLATE SYSTEM | Apr 01, 2013 | Substantially Equivalent | MONTERIS MEDICAL, INC. |
| K130671 | VENACURE EVLT NEVERTOUCH PROCEDURE KIT | Mar 26, 2013 | Substantially Equivalent | ANGIODYNAMICS, INC. |
| K130164 | FIBERLASE ENDURE CO2 FIBER | Mar 24, 2013 | Substantially Equivalent | LUMENIS LTD. |
| K130413 | PINPOINTE FOOTLASER | Mar 21, 2013 | Substantially Equivalent | NUVOLASE, INC. |
| K130344 | DORNIER MEDILAS UROPULSE | Mar 21, 2013 | Substantially Equivalent | DORNIER MEDTECH AMERICA, INC. |
| K123682 | INMODE HAIR REMOVAL (HR) DEVICE | Feb 27, 2013 | Substantially Equivalent | INMODE MD LTD. |
| K110941 | REVOLIX JR 30, REVOLIX JR 50, REVOLIX JR 160, REVOLIX FR 200 | Feb 19, 2013 | Substantially Equivalent | ALLMED SYSTEMS INC. |
| K123494 | SOLEA | Feb 11, 2013 | Substantially Equivalent | CONVERGENT DENTAL, INC |
| K122159 | DORNIER MEDILAS H30 SOLVO | Feb 01, 2013 | Substantially Equivalent | DORNIER MEDTECH AMERICA, INC. |
| K121327 | DIOLASE 10S | Feb 01, 2013 | Substantially Equivalent | BIOLASE TECHNOLOGY, INC. |
| K113504 | DEKA SMARTXIDE AND DELIVERY ACCESSORIES | Feb 01, 2013 | Substantially Equivalent | EL.EN. ELECTRONIC ENGINEERING SPA |
| K122251 | VITRA MULTISPOT | Jan 24, 2013 | Substantially Equivalent | QUANTEL MEDICAL |
| K124003 | MED-FIBERS SURGICAL LASER FIBER, MED-FIBERS ENDO-ENT LASER PROBES, MED-FIBERS END- AND ASPIRATING LASER PROBES, MED-FIBE | Jan 17, 2013 | Substantially Equivalent | MED-FIBERS, INC. |
| K121570 | AURIGA QI | Jan 16, 2013 | Substantially Equivalent | STARMEDTEC GMBH |
| K123004 | MIRA LASERS | Jan 15, 2013 | Substantially Equivalent | MIRA LASERS LLC |
| K122922 | E-BEAM ND: YAG LASER | Jan 10, 2013 | Substantially Equivalent | ECLIPSE AESTHETICS, LLC |
| K123168 | Q-PLUS T+ IPL LASER SYSTEM | Dec 20, 2012 | Substantially Equivalent | Quanta System SpA |
| K123385 | MEDILAS H LASER FIBERS | Dec 14, 2012 | Substantially Equivalent | DORNIER MEDTECH AMERICA, INC. |
| K123257 | EMVERA DIOLUX | Dec 14, 2012 | Substantially Equivalent | EMVERA TECHNOLOGIES, INC. |
| K113018 | APOLLO V+ MEDICAL PLATFORM, APOLLO IV+ MEDICAL PLATFORM, NICE STATION LIGHT BASED PLATFORM | Dec 14, 2012 | Substantially Equivalent | BEIJING SYNTECH LASER CO., LTD. |
| K120932 | OPELASER PRO II AND THE OPELASER LITE II | Dec 07, 2012 | Substantially Equivalent | THE YOSHIDA DENTAL MFG. CO., LTD. |
| K123031 | BWF-5 MEDICAL LASER SERIES | Dec 03, 2012 | Substantially Equivalent | LITECURE, LLC |
| K123037 | LIGHTSCALPEL | Nov 29, 2012 | Substantially Equivalent | LIGHTSCALPEL LLC |
| K121475 | TXCELL SCANNING LASER DELIVERY SYSTEM | Nov 28, 2012 | Substantially Equivalent | IRIDEX CORP. |
| K121346 | PICOSURE WORKSTATION | Nov 27, 2012 | Substantially Equivalent | CYNOSURE, INC. |
| K120460 | SMARTLUX | Oct 01, 2012 | Substantially Equivalent | MEDMIX CO., LTD |
| K121286 | EPIC 10 | Sep 28, 2012 | Substantially Equivalent | BIOLASE TECHNOLOGY, INC. |
| K121580 | SURELASE CO2 LASER SYSTEM | Sep 25, 2012 | Substantially Equivalent | CLINICON CORP. |
| K120235 | MODEL FAMILY OF AEROLASE ND:YAG LASERS: FRIENDLYLIGHT ND: YAG LASERS, FRIENDLYLIGHT NEO, LIGHTPOD ND: YAG LASERS, LIGHTP | Sep 17, 2012 | Substantially Equivalent | AEROLASE MEDICAL LASERS LLC |
| K120737 | TRIA LASER HAIR REMOVAL SYSTEM | Sep 13, 2012 | Substantially Equivalent | TRIA BEAUTY, INC. |
| K113472 | PRECISE SHP DIODE LASER | Aug 30, 2012 | Substantially Equivalent | CAO GROUP, INC. |
| K121938 | MEDILAS H RFID LASER FIBER | Aug 01, 2012 | Substantially Equivalent | DORNIER MEDTECH AMERICA, INC. |
| K120926 | ENDOBEAM HOLMIUM LASER FIBERS | Jul 27, 2012 | Substantially Equivalent | C.R. BARD, INC. |
| K113489 | ORION | Jul 27, 2012 | Substantially Equivalent | ASCLEPION LASER TECHNOLOGIES GMBH |
| K120377 | ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-A | Jul 25, 2012 | Substantially Equivalent | J. MORITA USA, INC. |
| K121162 | POLARIS Q-SWITCH RUBY SYSTEM | Jul 18, 2012 | Substantially Equivalent | SANDSTONE MEDICAL TECHNOLOGIES, LLC |
| K121471 | LIGHTSCALPEL FAMILY OF HANDPIECE TIPS FOR CO2 SURGICAL LASERS | Jul 10, 2012 | Substantially Equivalent | LIGHTSCALPEL LLC |
| K120810 | FIBEROPTIC LASER DELIVERY SYSTEM | Jun 28, 2012 | Substantially Equivalent | FIBEROPTIC FABRICATIONS INC |
| K121031 | WAVELIGHT FS200 PATIENT INTERFACE 1505 | Jun 21, 2012 | Substantially Equivalent | ALCON RESEARCH, LTD. |
| K120870 | GREENLIGHT MOXY FIBER OPTIC | Jun 15, 2012 | Substantially Equivalent | AMERICAN MEDICAL SYSTEMS |
| K120573 | MEDART 620 | Jun 13, 2012 | Substantially Equivalent | MEDART A/S |
| K113868 | EPLUS SKIN TREATMENT SYSTEM | Jun 11, 2012 | Substantially Equivalent | SYNERON, LTD. |
| K120622 | PALOMAR VECTUS LASER | May 23, 2012 | Substantially Equivalent | PALOMAR MEDICAL TECHNOLOGIES, INC. |
| K121127 | SIDELAZE LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440NM WAVELENGTH LASERS | May 13, 2012 | Substantially Equivalent | CYNOSURE, INC. |
| K112669 | TATTOOSTAR EFFECT Y | May 11, 2012 | Substantially Equivalent | ASCLEPION LASER TECHNOLOGIES GMBH |
| K120437 | TWISTER SIDE-FIRE FIBER OPTIC DELIVERY SYSTEM | Apr 26, 2012 | Substantially Equivalent | BIOLITEC SIA (LATVIA) |
| K120231 | EVOLVE HPD 980/ 1470NM MULTIWAVELENGTH DIODE LASER (EVOLVE DUAL) | Apr 24, 2012 | Substantially Equivalent | BIOLITEC MEDICAL DEVICES, INC |
| K112141 | SMARTEPIL,DEPILASE YAG LASE PLUS | Apr 13, 2012 | Substantially Equivalent | CASTLE LASER SYSTEMS, LIMITED |
| K112505 | ETHEREA | Apr 06, 2012 | Substantially Equivalent | REGULATORY INSIGHT, INC. |
| K113502 | ADVANTAGE LASER SYSTEM | Apr 05, 2012 | Substantially Equivalent | LUTRONIC CORPORATION |
| K113115 | EPICARE YAG | Apr 03, 2012 | Substantially Equivalent | LIGHT AGE, INC. |
| K113688 | MEGABEAM REUSABLE FIBER OPTIC DELIVERY SYSTEM | Mar 13, 2012 | Substantially Equivalent | BIOLITEC MEDICAL DEVICES, INC |
| K113151 | IFS LASER SYSTEM | Mar 08, 2012 | Substantially Equivalent | ABBOTT MEDICAL OPTICS INC |
| K113588 | SPECTRA LASER SYSTEM | Feb 22, 2012 | Substantially Equivalent | LUTRONIC CORPORATION |
| K111689 | STLASE | Feb 16, 2012 | Substantially Equivalent | DENTAL PHOTONICS, INC |
| K113390 | LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500) | Feb 14, 2012 | Substantially Equivalent | MERIDIAN AG |
| K112600 | ANGIODYNAMICS, INC. VENACURE NEVERTOUCH DIRECT PROCEDURE KIT | Jan 30, 2012 | Substantially Equivalent | ANGIODYNAMICS, INC. |
| K113858 | MEGABEAM ENDO-ENT PROBE | Jan 24, 2012 | Substantially Equivalent | BIOLITEC MEDICAL DEVICES, INC |
| K113709 | MEGABEAM FIBER OPTIC DELIVERY SYSTEM WITH ADDITIONAL TIPS & HANDPIECE | Jan 20, 2012 | Substantially Equivalent | BIOLITEC MEDICAL DEVICES, INC |
| K113792 | MEGABEAM ENDOCULAR PROBE AND ASPIRATING ENDOCULAR PROBE | Jan 19, 2012 | Substantially Equivalent | BIOLITEC MEDICAL DEVICES, INC |
| K112013 | EVOLVE(R) HPD 980/1470NM MULTIWAVELENGTH DIODE LASER | Jan 13, 2012 | Substantially Equivalent | BIOLITEC, INC. |
| K113140 | VARI-LASE WIREFIBER LASER FIBER | Dec 22, 2011 | Substantially Equivalent | VASCULAR SOLUTIONS, INC. |
| K111303 | DERMATOLOGICAL TREATMENT DEVICE FAMILY | Dec 21, 2011 | Substantially Equivalent | SHARPLIGHT TECHNOLOGIES LTD. |
| K112987 | TWISTER SIDE FIRE OPTICAL FIBER DELIVERY SYSTEM | Dec 16, 2011 | Substantially Equivalent | BIOLITEC MEDICAL DEVICES, INC |
| K110364 | DORNIER MEDILAS D LITEBEAM+ 1470 | Dec 07, 2011 | Substantially Equivalent | DORNIER MEDTECH AMERICA, INC. |
| K113212 | DENTAL LASER THERAPY SYSTEM | Nov 16, 2011 | Substantially Equivalent | CHINA DAHENG GROUP, INC. |
| K112299 | ENDOVASCULAR LASER VEIN SYSTEM KIT | Nov 03, 2011 | Substantially Equivalent | BIOLITEC MEDICAL DEVICES, INC |
| K112166 | ULTRALASE FLEXIBLE CO2 LASER WAVEGUIDE | Oct 21, 2011 | Substantially Equivalent | W AND R INVESTMENTS DBA LASER ENGINEERING |
| K112715 | CANDELA GENTLEMAX FAMILY OF LASERS | Oct 05, 2011 | Substantially Equivalent | CANDELA CORP. |
| K112442 | RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM | Sep 30, 2011 | Substantially Equivalent | BIOLITEC MEDICAL DEVICES, INC |
| K111475 | AURIGA XL | Sep 28, 2011 | Substantially Equivalent | STARMEDTEC GMBH |
| K112253 | CERALAS 147NM DIODE LASER SYSTEM | Sep 20, 2011 | Substantially Equivalent | BIOLITEC, INC. |
| K102359 | PICASSO/ PICASSO LITE/ PICASSO PERIO | Sep 16, 2011 | Substantially Equivalent | AMD LASERS, LLC |
| K111360 | SHEAUMANN PL-980 | Sep 14, 2011 | Substantially Equivalent | SHEAUMANN LASERS |
| K112031 | ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATION | Sep 13, 2011 | Substantially Equivalent | ALMA LASERS, INC. |
| K111359 | SHEAUMANN PL-1064 | Sep 13, 2011 | Substantially Equivalent | SHEAUMANN LASERS |
| K112324 | CERALAS 980NM DIODE LASER FAMILY | Sep 06, 2011 | Substantially Equivalent | BIOLITEC MEDICAL DEVICES, INC |
| K111592 | YOULASER CO2 LASER SYSTEM | Aug 25, 2011 | Substantially Equivalent | QUANTA SYSTEM, S.P.A. |
| K111213 | VISION ONE LASER SYSTEM | Jul 25, 2011 | Substantially Equivalent | LUMENIS INC. |
| K111144 | CANDELA GENTLELASE FAMILY OF LASERS | Jul 18, 2011 | Substantially Equivalent | CANDELA CORP. |
| K111851 | MEDIOSTAR NEXT | Jul 08, 2011 | Substantially Equivalent | ASCLEPION LASER TECHNOLOGIES GMBH |
| K110897 | CORTEX CO2 / ER:YAG LASER SYSTEM | Jul 01, 2011 | Substantially Equivalent | SANDSTONE MEDICAL TECHNOLOGIES, LLC |
| K101306 | SP DYNAMIS, SP SPECTRO, XS DYNAMIS, XS SPECTRO, XP DYNAMIS, XP SPECTRO, MODELS M021-4AF/3, M002-2A | Jul 01, 2011 | Substantially Equivalent | FOTONA D.D. |
| K110243 | MEDART DIODE LASER SYSTEM & ACCESSORIES | Jun 28, 2011 | Substantially Equivalent | MEDART A/S |
| K110907 | PALOMAR ICON (TM) AESTHETIC SYSTEM | Jun 22, 2011 | Substantially Equivalent | PALOMAR MEDICAL TECHNOLOGIES, INC. |
| K102954 | CUTERA QSWITCH LASER SYSTEM | Jun 22, 2011 | Substantially Equivalent | CUTERA, INC. |
| K110225 | ANGIODYNAMICS, INC. VENACURE 1470 LASER | May 13, 2011 | Substantially Equivalent | ANGIODYNAMICS, INC. |
| K103455 | SPECTRA LASER SYSTEM | Apr 28, 2011 | Substantially Equivalent | LUTRONIC CORPORATION |
| K110502 | TRIPLEX ER. YAG / ND: YAG SYSTEM | Apr 27, 2011 | Substantially Equivalent | SANDSTONE MEDICAL TECHNOLOGIES, LLC |
| K110434 | TRIXEL CO2 LASER | Apr 19, 2011 | Substantially Equivalent | BEIJING SYNTECH LASER CO., LTD. |
| K110304 | APEX ER. YAG / IPL SYSTEM | Apr 08, 2011 | Substantially Equivalent | SANDSTONE MEDICAL TECHNOLOGIES LLC |
| K103654 | VELA XL | Apr 06, 2011 | Substantially Equivalent | STARMEDTEC GMBH |
| K110685 | FLEXIVA TRACTIP | Mar 29, 2011 | Substantially Equivalent | BOSTON SCIENTIFIC CORP. |
| K110686 | ACCUTRAC | Mar 28, 2011 | Substantially Equivalent | BOSTON SCIENTIFIC CORP. |
| K101916 | JOULE MULTI-PLATFORM SYSTEM | Mar 18, 2011 | Substantially Equivalent | SCITON, INC. |
| K110080 | RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM | Feb 24, 2011 | Substantially Equivalent | BIOLITEC, INC. |
| K103753 | SIROLASER ADVANCE, SIROLASER XTEND, SIROLASER XTEND UPGRADED, FONALASER | Feb 15, 2011 | Substantially Equivalent | SIRONA DENTAL SYSTEMS GMBH |
| K110079 | SPPHINE PLUS STM 3W DIODE LASER | Feb 10, 2011 | Substantially Equivalent | DEN-MAT HOLDINGS, LLC |
| K103288 | DEKA SYNCHRO FT | Jan 31, 2011 | Substantially Equivalent | EL.EN. ELECTRONIC ENGINEERING SPA |
| K103539 | QUANTA SYSTEM DUOLITE | Jan 20, 2011 | Substantially Equivalent | QUANTA SYSTEM, S.P.A. |
| K103501 | ALMA LASERS PIXEL CO2 LASER SYSTEM, DELIVERY DEVICE AND ACCESSORIES | Jan 14, 2011 | Substantially Equivalent | ALMA LASERS, INC. |
| K101904 | SMARTXIDE 50 HS/MS | Jan 12, 2011 | Substantially Equivalent | EL.EN. ELECTRONIC ENGINEERING SPA |
| K103667 | SAPPHIRE ST PORTABLE DIODE LASER | Dec 29, 2010 | Substantially Equivalent | DEN-MAT HOLDINGS, LLC |
| K102755 | CERALAS E/ 1470NM FIBER-COUPLED DIODE LASER FAMILY; CREALAS HPD MULTIWAVELENGHT 980NM/ 1470NM FIBER-COUPLED DIODE LASER | Dec 16, 2010 | Substantially Equivalent | BIOLITEC, INC. |
| K102796 | ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT | Dec 15, 2010 | Substantially Equivalent | ANGIODYNAMICS, INC. |
| K102749 | QUANTA CYBER TM 150W | Dec 10, 2010 | Substantially Equivalent | Quanta System SpA |
| K102639 | SL3 | Dec 01, 2010 | Substantially Equivalent | DISCUS DENTAL, LLC |
| K100199 | ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND VENACUREEVLT PROCEDURE KIT | Nov 26, 2010 | Substantially Equivalent | ANGIODYNAMICS, INC. |
| K101817 | LIGHTWALKER AT, MODEL M021-5AF/1, LIGHTWALKER DT, MODEL M021-5AF/2, LIGHTWALKER ST-E, MODEL M002-6A/2, LIGHTWALKER ST-N | Nov 22, 2010 | Substantially Equivalent | FOTONA D.D. |
| K103118 | REVLITE Q-SWITCHED ND: YAG LASER SYSTEM WITH NADPIECE ADAPTOR | Nov 19, 2010 | Substantially Equivalent | HOYA PHOTONICS, INC. |
| K102669 | DIODE LASER THERAPY SYSTEM | Nov 17, 2010 | Substantially Equivalent | CHINA DAHENG GROUP, INC. |
| K101321 | EMATRIX CO2 | Nov 09, 2010 | Substantially Equivalent | SYNERON MEDICAL LTD. |
| K101712 | ENDOVASCULAR LAER VEIN SYSTEM KIT | Oct 27, 2010 | Substantially Equivalent | BIOLITEC, INC. |
| K101006 | WAVELIGHT FS200 LASER SYSTEM MODEL: FS200 | Oct 21, 2010 | Substantially Equivalent | ALCON RESEARCH, LTD. |
| K093545 | PINPOINTE FOOTLASER MODEL 6W, 30W, 100W | Oct 15, 2010 | Substantially Equivalent | INCISIVE, INC. (FORMERLY NAMED INCISIVE, LLC) |
| K102716 | MODIFIED ALMA LASERS FAMILY OF SOPRANO XL MULTI-APPLICATION PLATMFORMS | Sep 28, 2010 | Substantially Equivalent | ALMA LASERS, INC. |
| K102036 | DOCTOR SURGERY DIODE LASERS FAMILY | Sep 28, 2010 | Substantially Equivalent | LAMBDA S.P.A. |
| K101601 | AFFIRM DO DIODE LASER | Sep 23, 2010 | Substantially Equivalent | CYNOSURE, INC. |
| K101573 | ACCUSCULPT II LASER SYSTEM | Sep 23, 2010 | Substantially Equivalent | LUTRONIC CORPORATION |
| K092734 | E-LIGHT LINE | Sep 20, 2010 | Substantially Equivalent | ESPANSIONE MARKETING S.P.A |
| K101555 | CO2 LASER SYSTEM | Sep 17, 2010 | Substantially Equivalent | ADVANCED TECHNOLOGY LASER CO., LTD. |
| K100726 | CERALAS D/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS HPD/ 980NM | Sep 15, 2010 | Substantially Equivalent | BIOLITEC, INC. |
| K101783 | COOLTOUCH MODEL CT3PZ, COOLTOUCH CT3 PLUS COOLBREEZE | Sep 13, 2010 | Substantially Equivalent | NEW STAR LASERS, INC. |
| K094049 | STLASE DIODE LASER | Sep 10, 2010 | Substantially Equivalent | DENTAL PHOTONICS, INC |
| K101152 | NATURALASE DIODE LASER FAMILY NATURALASE MODEL NL980, NATURALASE DIODE LASER FAMILY NATURALASE NL810 | Aug 18, 2010 | Substantially Equivalent | FOCUS MEDICAL, LLC. |
| K100143 | PILOT DIODE LASER, MODEL 002-00139 | Aug 13, 2010 | Substantially Equivalent | CAO GROUP, INC. |
| K100098 | PLASMALIPO/PLASMA D30 LSER SURGICAL DEVICE | Aug 13, 2010 | Substantially Equivalent | JM SYSTEM CO., LTD. |
| K101658 | WATERLASE MD TURBO PLUS MODEL 7200XXX | Aug 11, 2010 | Substantially Equivalent | BIOLASE TECHNOLOGY, INC. |
| K102050 | Q-SWITCHED ND:YAG LASER SYSTEM, MODEL GLOBALCURE-SC6 | Jul 29, 2010 | Substantially Equivalent | ADVANCED TECHNOLOGY LASER CO., LTD. |
| K100558 | QUANTA DIODE LASER SYSTEM | Jul 22, 2010 | Substantially Equivalent | QUANTA SYSTEM, S.P.A. |
| K100678 | SUPRA SCAN DELIVERY SYSTEM | Jul 21, 2010 | Substantially Equivalent | QUANTEL MEDICAL |
| K092860 | LASEMAR 800, 1000, 1500 | Jul 16, 2010 | Substantially Equivalent | EUFOTON S.R.L. |
| K101415 | THERACLEAR | Jul 08, 2010 | Substantially Equivalent | THERAVANT CORPORATION |
| K100893 | CHEVEUX DIODE LASER SYSTEM | Jun 16, 2010 | Substantially Equivalent | SANDSTONE MEDICAL TECHNOLOGIES, LLC |
| K100746 | FIBER ONE | Jun 11, 2010 | Substantially Equivalent | AMERICAN MEDICAL SYSTEMS |
| K100194 | OPTICAL INTEGRITY LASERGUARD FIBERS | May 20, 2010 | Substantially Equivalent | OPTICAL INTEGRITY, INC. |
| K093087 | BWF-5 MEDICAL LASER SERIES | May 12, 2010 | Substantially Equivalent | LITECURE, LLC |
| K100415 | ACUPULSE 30/40 ST CO2 LASER SYSTEM AND ACUPULSE 40WG CO2 LASER SYSTEM | Apr 21, 2010 | Substantially Equivalent | LUMENIS |
| K100384 | FIBERLASE C02 LASER WAVEGUIDE | Apr 12, 2010 | Substantially Equivalent | LUMENIS, LTD. |
| K100270 | ARTISAN AESTHETIC SYSTEM | Mar 29, 2010 | Substantially Equivalent | PALOMAR MEDICAL TECHNOLOGIES, INC. |
| K093048 | D-STORM 810NM, D-STORM 980NM | Mar 23, 2010 | Substantially Equivalent | LIGHT INSTRUMENTS |
| K100035 | MODEL VISULAS 532S LASER WITH THE VITE OPTION | Mar 17, 2010 | Substantially Equivalent | CARL ZEISS MEDITEC AG |
| K100474 | QUICKLASEDUAL+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 MODEL: 3W,5W,3W,5W | Mar 16, 2010 | Substantially Equivalent | QUICKLASE LIMITED |
| K093852 | EZLASE 3 LASER SYSTEM | Mar 12, 2010 | Substantially Equivalent | BIOLASE TECHNOLOGY, INC. |
| K100228 | VERSAPULSE MODEL P20 LASER SYSTEM | Feb 24, 2010 | Substantially Equivalent | LUMENIS, INC. |
| K093793 | LS-40 CO2 LASER SYSTEM MODEL LS-40 | Feb 18, 2010 | Substantially Equivalent | SANDSTONE MEDICAL TECHNOLOGIES, LLC |
| K100078 | MODIFIED STRAIGHT FIRE LASER FIBER | Feb 12, 2010 | Substantially Equivalent | BOSTON SCIENTIFIC CORP. |
| K082230 | VECTRA PLUS LASER SYSTEM AND ACCESSORIES | Feb 03, 2010 | Substantially Equivalent | XINTEC CORPORATION |
| K093162 | FIDELIS PLUS III D, AT FIDELIS D, POWERLASE AT D / FIDELIS PLUS III, AT FIDELIS, POWERLASE AT / FIDELIS ER III D, HT FID | Jan 22, 2010 | Substantially Equivalent | FOTONA D.D. |
| K093502 | VARI-LASE ENDOVENOUS LASER CONSOLE | Jan 07, 2010 | Substantially Equivalent | VASCULAR SOLUTIONS, INC. |
| K090312 | TRIA ACNE TREATMENT SYSTEM, MODEL ATS-1 OTC | Jan 05, 2010 | Substantially Equivalent | TRIA BEAUTY, INC. |
| K082586 | LIGHTWAVE PROFESSIONAL DELUXE | Jan 04, 2010 | Substantially Equivalent | LIGHTWAVE TECHNOLOGIES LLC |
| K090820 | TRIA HAIR REMOVAL LASER SYSTEM | Dec 23, 2009 | Substantially Equivalent | SPECTRAGENICS, INC. |
| K093691 | ACCUMAX | Dec 11, 2009 | Substantially Equivalent | BOSTON SCIENTIFIC CORP. |
| K092964 | COOLTOUCH VARIA ND:YAG LASER SYSTEM | Dec 11, 2009 | Substantially Equivalent | NEW STAR LASERS, INC. |
| K091746 | WATERLASE MD, MODEL 7100102 | Dec 07, 2009 | Substantially Equivalent | BIOLASE TECHNOLOGY, INC. |
| K092660 | SIROLASER ADVANCE | Dec 03, 2009 | Substantially Equivalent | SIRONA DENTAL SYSTEMS GMBH |
| K083123 | MEDART MODEL 610 CO2 LASER SYSTEM & ACCESSORIES | Nov 24, 2009 | Substantially Equivalent | MEDART A/S |
| K093451 | OMNIGUIDE BEAMPATH CO2 MARK III WAVEGUIDE FIBER WITH LOW PROFILE/LOW LOSS TIP | Nov 20, 2009 | Substantially Equivalent | OMNIGUIDE, INC. |
| K090195 | PALOMAR LUX1540 HANDPIECE | Nov 20, 2009 | Substantially Equivalent | PALOMAR MEDICAL TECHNOLOGIES, INC. |
| K092735 | GREENLIGHT XPS LASER SYSTEM | Nov 09, 2009 | Substantially Equivalent | AMERICAN MEDICAL SYSTEMS, INC. |
| K091625 | EPICARE-DUO LASER SYSTEM | Nov 03, 2009 | Substantially Equivalent | LIGHT AGE, INC. |
| K091115 | ECO2 LASER SYSTEM | Oct 30, 2009 | Substantially Equivalent | LUTRONIC CORPORATION |
| K093251 | OMNIGUIDE BEAMPATH FELS 25A CO2 LASER SYSTEM | Oct 29, 2009 | Substantially Equivalent | OMNIGUIDE, INC. |
| K092197 | PHOTEX30 DIODE LASER SERIES: 980, 810, 940 | Oct 06, 2009 | Substantially Equivalent | BIOTEX, INC. |
| K083927 | WATERLASE MD | Oct 01, 2009 | Substantially Equivalent | BIOLASE TECHNOLOGY, INC. |
| K091800 | LIPOEZE LASER ASSISTED ASPIRATION CANNULA | Sep 23, 2009 | Substantially Equivalent | CURVE MEDICAL |
| K091562 | DOCTOR SMILE A-810 AND B-980 LASERS | Sep 08, 2009 | Substantially Equivalent | LAMBDA SCIENTIFIC SPA |
| K091537 | CYNOSURE SMARTLIPO MULTIWAVELENGTH LASER WITH 1440NM WAVELENGTH | Sep 03, 2009 | Substantially Equivalent | CYNOSURE, INC. |
| K090762 | LEDA | Aug 28, 2009 | Substantially Equivalent | QUANTEL DERMA GMBH |
| K091320 | SPECTRA SP II, SPECTRA DENTA II | Aug 19, 2009 | Substantially Equivalent | LUTRONIC CORPORATION |
| K091059 | FOXQ 980 LASER | Aug 13, 2009 | Substantially Equivalent | A.R.C. LASER GMBH |
| K090571 | ALMA LASERS ALEX755 MODULE | Aug 13, 2009 | Substantially Equivalent | ALMA LASERS LTD. |
| K091796 | SOFTLASE PRO, ORTHOLASE AND HYGIENELASE | Jul 31, 2009 | Substantially Equivalent | ZAP LASERS, LLC |
| K091666 | PASCAL PHOTOCOAGULATOR, PASCAL-US | Jul 15, 2009 | Substantially Equivalent | OPTIMEDICA CORPORATION |
| K091922 | WATERLASE C100, MODEL 7100104 | Jul 14, 2009 | Substantially Equivalent | BIOLASE TECHNOLOGY, INC. |
| K091909 | LITHO LASER SYSTEM | Jul 09, 2009 | Substantially Equivalent | QUANTA SYSTEM, S.P.A. |
| K090126 | FOTONA XP ND: YAG LASER SYSTEM FAMILY, FOTONA XP, XP-2 FOCUS, FOTONA XP CHANGER,MODEL MOO1-14F, MOO1-14F, MOO1-14F/2, | Jun 29, 2009 | Substantially Equivalent | FOTONA D.D. |
| K090164 | CERALAS MULTIWAVELENGTH 980/1470NM DIODE LASER | Jun 26, 2009 | Substantially Equivalent | BIOLITEC, INC. |
| K091551 | VARI-LASE PLATINUM BRIGHT TIP LASER FIBER | Jun 19, 2009 | Substantially Equivalent | VASCULAR SOLUTIONS, INC. |
| K090962 | CYBER SURGICAL LASER FAMILY INCLUDING: CYBER TM, CYBER GREEN, CYBER GREEN TM | Jun 19, 2009 | Substantially Equivalent | QUANTA SYSTEM, S.P.A. |
| K083616 | PATHOLASE FAMILY OF PINPOINTE AND PINPOINTE FOOTLASER ND: YAG LASERS | Jun 12, 2009 | Substantially Equivalent | PATHOLASE, INC |
| K091323 | MODIFIED INTERMEDIC DIODE LASER 980NM SYSTEM (MULTIDIODE SST 200) | Jun 04, 2009 | Substantially Equivalent | INTERMEDIC ARFRAN, S.A. |
| K090776 | MEGAPULSE LASER SYSTEM AND FIBERS | Jun 02, 2009 | Substantially Equivalent | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| K083899 | REVLITE Q-SWITCHED ND:YAG LASER SYSTEM | Jun 01, 2009 | Substantially Equivalent | HOYA CONBIO, INC |
| K090094 | ZELTIQ SYSTEM | May 20, 2009 | Substantially Equivalent | ZELTIQ AESTHETICS |
| K083253 | LOTUS II PULSED ER: YAG LASER SYSTEM | May 15, 2009 | Substantially Equivalent | LASEROPTEK CO. LTD. |
| K091169 | ELITE MPX LASER SYSTEM WITH CRYO C | May 13, 2009 | Substantially Equivalent | CYNOSURE, INC. |
| K083733 | LUME 2 SYSTEM, MODEL GA0005000 | May 04, 2009 | Substantially Equivalent | LUMENIS, LTD. |
| K081509 | MONTERIS MEDICAL AUTOLITT LASER PROBE | May 01, 2009 | Substantially Equivalent | MONTERIS MEDICAL |
| K083203 | HELIOS II Q-SWITCHED ND:YAG LASER SYSTEM | Apr 28, 2009 | Substantially Equivalent | LASEROPTEK CO. LTD. |
| K083889 | FOTONA QX ND:YAG/KTP LASER SYSTEM FAMILY | Apr 23, 2009 | Substantially Equivalent | FOTONA D.D. |
| K090618 | CYNOSURE SMARTCOOL FAMILY COLD AIR DEVICE: SMARTCOOL, SMARTCOOL 6 AND CRYO C | Apr 14, 2009 | Substantially Equivalent | CYNOSURE, INC. |
| K090297 | BLUESHINE GOLD SERIES | Apr 14, 2009 | Substantially Equivalent | BLUESHINE SRL |
| K083848 | ALMA LASERS SOPRANO XL MULTI-APPLICATION PLATFORM | Apr 14, 2009 | Substantially Equivalent | ALMA LASERS LTD. |
| K083215 | INCISIVE FAMILY OF INPULSE ND:YAG LASERS | Apr 08, 2009 | Substantially Equivalent | INCISIVE, LLC. |
| K090410 | COOLTOUCH THERMAL SENSING HANDPIECE ACCESSORY | Mar 27, 2009 | Substantially Equivalent | NEW STAR LASERS, INC. |
| K082039 | SYNCHRO HP PLATFORM | Mar 20, 2009 | Substantially Equivalent | EL.EN. ELECTRONIC ENGINEERING SPA |
| K081424 | AFFIRM CO2 AND AFFIRM CO2 HP | Mar 19, 2009 | Substantially Equivalent | CYNOSURE, INC. |
| K090235 | ELITE MPX LASER SYSTEM WITH XPL HANDPIECE | Mar 17, 2009 | Substantially Equivalent | CYNOSURE, INC. |
| K083478 | SMOOTHLIPO | Mar 17, 2009 | Substantially Equivalent | ELEME MEDICAL, INC. |
| K083142 | PICASSO LASER SYSTEM | Mar 13, 2009 | Substantially Equivalent | AMD LASERS, LLC |
| K090084 | ELATION ENDOVENOUS LASER PROCEDURE KIT UNIVERSAL FLUID DISPENSING SYRINGE | Mar 06, 2009 | Substantially Equivalent | MERIT MEDICAL SYSTEMS, INC. |
| K090281 | ACCUTECH FAMILY OF POWERFLEX LASER DELIVERY DEVICES | Mar 04, 2009 | Substantially Equivalent | ACCUTECH MEDICAL TECHNOLOGIES, INC. |
| K083900 | ERBIUM FRACTIONAL HANDPIECE | Feb 27, 2009 | Substantially Equivalent | PALOMAR MEDICAL PRODUCTS, INC. |
| K081541 | DERMABLATE EFFECT | Feb 23, 2009 | Substantially Equivalent | ASCLEPION LASER TECHNOLOGIES GMBH |
| K083165 | PALOMAR ASPIRE LASER PLATFORM | Feb 13, 2009 | Substantially Equivalent | PALOMAR MEDICAL PRODUCTS, INC. |
| K083500 | MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE | Feb 12, 2009 | Substantially Equivalent | DORNIER MEDTECH AMERICA, INC. |
| K090181 | WATERLASE MD | Feb 11, 2009 | Substantially Equivalent | BIOLASE TECHNOLOGY, INC. |
| K082825 | ENERGIST ULTRAPLUS VARIABLE PULSED LIGHT (VPL) SYSTEM | Feb 06, 2009 | Substantially Equivalent | ENERGIST, LTD. |
| K083034 | FOTONA XD-2 DIODE LASER SYSTEM, MODEL MD01-2F | Feb 04, 2009 | Substantially Equivalent | FOTONA D.D. |
| K082407 | MODIFICATION TO ULTRALIGHT II ND: YAG LASER SYSTEM | Feb 03, 2009 | Substantially Equivalent | SANDSTONE MEDICAL TECHNOLOGIES, LLC |
| K083918 | ATL CO2 MEDICAL LASER SYSTEMS, MODELS ATL-150 AND ATL-250 | Feb 02, 2009 | Substantially Equivalent | ADVANCED TECHNOLOGY LASER CO., LTD. |
| K083748 | IPULSE, MODEL: I150 | Feb 02, 2009 | Substantially Equivalent | CYDEN LIMITED |
| K083258 | MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE | Jan 30, 2009 | Substantially Equivalent | DORNIER MEDTECH AMERICA, INC. |
| K083915 | ANGELITE FAMILY OF INTENSE PULSED LIGHT SYSTEMS, MODELS ANGELITE-DDC AND ANGELITE-SDC | Jan 29, 2009 | Substantially Equivalent | ADVANCED TECHNOLOGY LASER CO., LTD. |
| K083795 | CYNOSURE SMARTLIPO MPX LASER | Jan 21, 2009 | Substantially Equivalent | CYNOSURE, INC. |
| K082409 | SOLAR LASER ABLATION SYSTEM, MODELS: LU-1083-25, LF-1083, PC-1000, IC-1083, LW-2000, LG-2001, LK-001, PM-1083, TF-1083 | Jan 21, 2009 | Substantially Equivalent | ENDOPHOTONIX, INC |
| K083082 | MOORVMS-LDF1 AND MOORVMS-LDF2 LASER DOPPLER PERFUSION AND TEMPERATURE MONITORS | Jan 13, 2009 | Substantially Equivalent | MOOR INSTRUMENTS LTD. |
| K083730 | ISOLAZ | Jan 09, 2009 | Substantially Equivalent | AESTHERA CORPORATION |
| K083682 | 180W CERELAS D 980NM DIODE LASER, MODEL D180 | Jan 09, 2009 | Substantially Equivalent | BIOLITEC, INC. |
| K083613 | QUANTA SYSTEM POLYSURGE DIODE LASER FAMILY | Dec 23, 2008 | Substantially Equivalent | QUANTA SYSTEM, S.P.A. |
| K083476 | NOVEON MODEL LS1100-03 | Dec 22, 2008 | Substantially Equivalent | NOMIR MEDICAL TECHNOLOGIES, INC. |
| K082938 | EZLASE | Dec 22, 2008 | Substantially Equivalent | BIOLASE TECHNOLOGY, INC. |
| K082911 | SMOOTHCOOL HR SYSTEM | Dec 19, 2008 | Substantially Equivalent | JEISYS MEDICAL, INC. |
| K082809 | ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM | Dec 18, 2008 | Substantially Equivalent | LUMENIS, INC. |
| K083272 | SKINCLEAR Q-SWITCHED ND:YAG LASER | Dec 16, 2008 | Substantially Equivalent | GLOBAL USA DISTRIBUTION, LLC. |
| K083379 | CYNOSURE SMARTLIPO MPX LASER WITH SMARTSENSE C MODULE | Dec 12, 2008 | Substantially Equivalent | CYNOSURE, INC. |
| K081095 | PROLITE III TOWER AND PR AND HR HANDPIECE | Dec 12, 2008 | Substantially Equivalent | QUANTEL S.A. |
| K082423 | NO!NO! SKIN | Dec 03, 2008 | Substantially Equivalent | RADIANCY (ISRAEL) LTD. |
| K082225 | 15W CERALAS D 1470NM DIODE LASER, MODEL D1470 | Dec 03, 2008 | Substantially Equivalent | BIOLITEC, INC. |
| K083207 | ULTRAWAVE III EX 1320 | Nov 14, 2008 | Substantially Equivalent | QUANTA SYSTEM, S.P.A. |
| K080591 | TANDA SKINCARE SYSTEM, MODEL: PTSCS | Nov 14, 2008 | Substantially Equivalent | PHAROS LIFE CORPORATION |
| K083069 | EZLASE 10W | Nov 13, 2008 | Substantially Equivalent | BIOLASE TECHNOLOGY, INC. |
| K082876 | BEAMAX/ FORMAX PULSED LIGHT DEVICE FAMILY | Nov 10, 2008 | Substantially Equivalent | SHARPLIGHT TECHNOLOGIES LTD. |
| K082101 | LS FAMILY OF CO2 LASERS WITH SCANNING HANDPIECE | Nov 05, 2008 | Substantially Equivalent | SANDSTONE MEDICAL TECHNOLOGIES, LLC |
| K082721 | LASERPRO 810, 940 AND 980 DIODE LASER SYSTEMS | Oct 28, 2008 | Substantially Equivalent | PHOTOMEDEX, INC. |
| K082263 | CERALAS E 980NM DIODE LASER, MODELS E15/980 AND E30/980 | Oct 24, 2008 | Substantially Equivalent | BIOLITEC, INC. |
| K082298 | FLASH N' GO | Oct 23, 2008 | Substantially Equivalent | HOME SKINOVATIONS LTD. |
| K081352 | PROFILE MULTI-PLATFORM SYSTEM | Oct 23, 2008 | Substantially Equivalent | SCITON, INC. |
| K081408 | ELLIPSE MULTIFLEX | Oct 17, 2008 | Substantially Equivalent | ELLIPSE A/S |
| K082928 | STRAIGHT FIRE HOLMIUM LASER FIBER | Oct 16, 2008 | Substantially Equivalent | BOSTON SCIENTIFIC CORP. |
| K082445 | CURATIVE980 DIODE LASER | Oct 15, 2008 | Substantially Equivalent | OROSCIENCE, INC. |
| K082232 | EVIS MD PLANTIUM BLUE | Oct 15, 2008 | Substantially Equivalent | AGELESS BEAUTY CORPORATION |
| K082247 | EVIS MD PLATINUM RED LIGHT THERAPY | Oct 08, 2008 | Substantially Equivalent | AGELESS BEAUTY CORPORATION |
| K082096 | POWERLIPO LASER SYSTEM | Oct 08, 2008 | Substantially Equivalent | LUTRONIC CORPORATION |
| K073022 | CLAREBLEND LED PROBES MODEL# 7201-415, 7204-631, 7205-830 | Oct 01, 2008 | Substantially Equivalent | CLAREBLEND, INC. |
| K073000 | LUMAPROBE | Oct 01, 2008 | Substantially Equivalent | CLAREBLEND, INC. |
| K082004 | SMOOTHKIT+ | Sep 26, 2008 | Substantially Equivalent | OSYRIS |
| K080382 | SELLAS | Sep 24, 2008 | Substantially Equivalent | DINONA CO., LTD. |
| K080638 | CLARO | Sep 17, 2008 | Substantially Equivalent | CLRS TECHNOLOGY CORPORATION |
| K073572 | MATRIX RF APPLICATOR | Sep 17, 2008 | Substantially Equivalent | SYNERON MEDICAL LTD. |
| K081704 | SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS | Sep 11, 2008 | Substantially Equivalent | LUMENIS, INC. |
| K081744 | PASCAL SYNTHESIS DELIVERY SYSTEM | Sep 09, 2008 | Substantially Equivalent | OPTIMEDICA CORPORATION |
| K073317 | STARLIGHT, MODEL PD9012 | Sep 03, 2008 | Substantially Equivalent | F.P. RUBINSTEIN Y CIA S.R.L. |
| K081652 | CLAROS NANO DENTAL LASER SYSTEM | Aug 28, 2008 | Substantially Equivalent | ELEXXION AG |
| K073158 | SCULPTURE 2.94 ER:YAG SYSTEM | Aug 27, 2008 | Substantially Equivalent | HOYA CONBIO, INC |
| K073427 | MEDILAS D FAMILY LASERS | Aug 20, 2008 | Substantially Equivalent | DORNIER MEDTECH AMERICA, INC. |
| K080530 | MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE | Aug 15, 2008 | Substantially Equivalent | CUTERA, INC. |
| K081939 | OMNIGUIDE BEAMPATH FIBER OPTIC HANDPIECE SYSTEM AND STERILIZATION TRAY | Aug 12, 2008 | Substantially Equivalent | OMNIGUIDE, INC. |
| K082028 | LASERPEEL SOFT-MET MODIFIED ERBIUM LASER | Aug 08, 2008 | Substantially Equivalent | GLOBAL USA DISTRIBUTION, LLC. |
| K081457 | ATRILAZE LASER ABLATION SYSTEM | Aug 08, 2008 | Substantially Equivalent | MEDICALCV, INC. |
| K071687 | FAMILI OF IRIDEX IQ LASER SYSTEMS | Aug 07, 2008 | Substantially Equivalent | IRIDEX CORP. |
| K082033 | NANNOLIGHT INTENSE PULSED LIGHT SYSTEM | Jul 31, 2008 | Substantially Equivalent | GLOBAL USA DISTRIBUTION, LLC. |
| K080463 | ALMA LASERS THERMOXEL CO2 LASER SYSTEM AND DELIVERY DEVICE ACCESSORIES | Jul 23, 2008 | Substantially Equivalent | ALMA LASERS LTD. |
| K081619 | CHROMOLITE EP | Jul 18, 2008 | Substantially Equivalent | CHROMOGENEX TECHNOLOGIES LIMITED |
| K080731 | PHARAON 980 ENDO/EXO, OSYFIBRE 600, CONTROL4+ HANDPIECE | Jul 17, 2008 | Substantially Equivalent | OSYRIS |
| K080975 | FENCER 308 EXCIMER LASER SYSTEM | Jul 15, 2008 | Substantially Equivalent | KERA HARVEST/LASER MAX MEDICAL TECHNOLOGIES CORP |
| K073074 | KEY LASER III 1243 US WITH DETECT | Jul 10, 2008 | Substantially Equivalent | KAVO AMERICA |
| K081015 | CERALAS D 980NM DIODE LASER, MODELS D15 AND D25 | Jul 08, 2008 | Substantially Equivalent | BIOLITEC, INC. |
| K080496 | MOSAIC ECO2 LASER SYSTEM | Jul 07, 2008 | Substantially Equivalent | LUTRONIC CORPORATION |
| K080915 | FRAXEL RE:PAIR (FRAXEL III SR) LASER SYSTEM AND ACCESSORIES | Jul 01, 2008 | Substantially Equivalent | RELIANT TECHNOLOGIES, INC. |
| K081219 | APOLLO MINI IPL SYSTEM | Jun 30, 2008 | Substantially Equivalent | SANDSTONE MEDICAL TECHNOLOGIES, LLC |
| K080959 | DORNIER MEDILAS D 30 LASER, MEDILAS D 1064 | Jun 27, 2008 | Substantially Equivalent | DORNIER MEDTECH AMERICA, INC. |
| K072182 | ALMA LASERS FAMILY OF THERMO-XEL HANDPIECES, PIXEL MODELS: 2940, 1060 | Jun 27, 2008 | Substantially Equivalent | ALMA LASERS LTD. |
| K081612 | AESCULIGHT FAMILY OF FLEXIBLE FIBERS, HANDPIECES AND TIPS FOR CO2 SURGICAL LASERS | Jun 25, 2008 | Substantially Equivalent | AESCULIGHT, LLC |
| K081628 | MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPO | Jun 20, 2008 | Substantially Equivalent | NEW STAR LASERS, INC. |
| K081578 | ACCELA SYSTEM | Jun 20, 2008 | Substantially Equivalent | GENESIS BIOSYSTEMS, INC. |
| K080244 | PALOMAR LUX 1540 HANDPIECE | Jun 20, 2008 | Substantially Equivalent | PALOMAR MEDICAL PRODUCTS, INC. |
| K081324 | CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASERS | Jun 17, 2008 | Substantially Equivalent | CANDELA CORP. |
| K081589 | WATERLASE, VERSION 3.0 | Jun 13, 2008 | Substantially Equivalent | BIOLASE TECHNOLOGY, INC. |
| K080932 | MOSAIC LASER SYSTEM | Jun 09, 2008 | Substantially Equivalent | LUTRONIC CORPORATION |
| K081416 | PALOMAR ASPIRE LASER PLATFORM | May 29, 2008 | Substantially Equivalent | PALOMAR MEDICAL PRODUCTS, INC. |
| K072564 | ALMA LASERS HARMONY XL MULTI-APPLICATION PLATFORM | May 23, 2008 | Substantially Equivalent | ALMA LASERS LTD. |
| K080374 | BIOSYAG MEDICAL SYSTEM | May 15, 2008 | Substantially Equivalent | BIOS S.R.L. |
| K081214 | STYLA MICROLASER AND STYLAORTHO | May 14, 2008 | Substantially Equivalent | ZAP LASERS, LLC |
| K073411 | LITEDUO | May 13, 2008 | Substantially Equivalent | LIGHT INSTRUMENTS |
| K073477 | PHOTONOVA FAMILY OF PULSED LIGHT SYSTEMS | May 09, 2008 | Substantially Equivalent | PHOTONOVA OFSWEDEN AB |
| K081181 | SMART CO2 (SMART US 20D / ULTRASPEED, SMART CLINIC AND PERIOPULSE) SURGICAL LASER | May 05, 2008 | Substantially Equivalent | CYNOSURE, INC. |
| K080118 | ZELTIQ AESTHETICS CLN1 DERMAL COOLING DEVICE | May 02, 2008 | Substantially Equivalent | ZELTIQ AESTHETICS |
| K073404 | IFS LASER SYSTEM | Apr 25, 2008 | Substantially Equivalent | INTRALASE CORP. |
| K080248 | SPECTRA VRMIII Q-SWITCHED ND: YAG LASER SYSTEM AND DYE HANDPIECES | Apr 23, 2008 | Substantially Equivalent | LUTRONIC CORPORATION |
| K073715 | ELIPO | Apr 23, 2008 | Substantially Equivalent | SYNERON MEDICAL LTD. |
| K072682 | 50W CERALAS D 1950NM DIODE LASER | Apr 18, 2008 | Substantially Equivalent | BIOLITEC, INC. |
| K080525 | COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W | Apr 17, 2008 | Substantially Equivalent | COOK UROLOGICAL, INC. |
| K080567 | PALOMAR ASPIRE LASER PLATFORM | Apr 16, 2008 | Substantially Equivalent | PALOMAR MEDICAL PRODUCTS, INC. |
| K080163 | COOLTOUCH MODELS LC215 AND COOLLIPO | Apr 10, 2008 | Substantially Equivalent | NEW STAR LASERS, INC. |
| K073617 | PHARAON LIPO | Apr 09, 2008 | Substantially Equivalent | OSYRIS |
| K080697 | SKIN CLEAR SRVH LONG-PULSED ND: YAG LASER | Apr 07, 2008 | Substantially Equivalent | GLOBAL USA DISTRIBUTION, LLC. |
| K080735 | CRYOMINI | Apr 04, 2008 | Substantially Equivalent | ZIMMER ELEKTROMEDIZIN GMBH |
| K073534 | CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS | Apr 03, 2008 | Substantially Equivalent | CANDELA CORP. |
| K080104 | VARI-LASE ENDOVENOUS LASER CONSOLE, MODEL 7542 | Mar 26, 2008 | Substantially Equivalent | VASCULAR SOLUTIONS, INC. |
| K073583 | MODIFICATION TO PALOMAR LUX1540 HANDPIECE | Mar 26, 2008 | Substantially Equivalent | PALOMAR MEDICAL PRODUCTS, INC. |
| K080406 | IPULSE, MODEL I400 | Mar 10, 2008 | Substantially Equivalent | CYDEN LIMITED |
| K073659 | XTRAC ULTRA 2, MODEL AL10000 | Mar 05, 2008 | Substantially Equivalent | PHOTO MEDEX, INC. |
| K070355 | FOTONA FIDELIS III ER:YAG/ND:YAG LASER SYSTEM FAMILY | Mar 04, 2008 | Substantially Equivalent | FOTONA D.D. |
| K080006 | AFFIRM WITH XPL HANDPIECE AND ER:YAG LASER MODULE | Feb 28, 2008 | Substantially Equivalent | CYNOSURE, INC. |
| K073549 | Q-PLUS T | Feb 28, 2008 | Substantially Equivalent | QUANTA SYSTEM, S.P.A. |
| K073048 | PETERIO UNIVERSAL LASER SCANNING HANDPIECE | Feb 28, 2008 | Substantially Equivalent | SCILEX, LTD. |
| K073063 | 15W CERALAS D 1470NM DIODE LASER | Feb 27, 2008 | Substantially Equivalent | BIOLITEC, INC. |
| K073322 | FOX 1-980, FOX Q-1064, FOX-Q-810 | Feb 22, 2008 | Substantially Equivalent | A.R.C. LASER GMBH |
| K071896 | FOX 940, MODEL 940 | Feb 22, 2008 | Substantially Equivalent | VALAM INC. |
| K073332 | V-RASER DIODE LASER SYSTEM | Feb 14, 2008 | Substantially Equivalent | HOYA CONBIO, INC |
| K071363 | WATERLASE AND WATERLASE MD | Feb 12, 2008 | Substantially Equivalent | BIOLASE TECHNOLOGY, INC. |
| K053527 | SPECTRA HAIR REMOVAL LASER | Feb 01, 2008 | Substantially Equivalent | SPECTRAGENICS, INC. |
| K080121 | CYNOSURE SMARTLIPO MULTIWAVLENGTH LASER | Jan 31, 2008 | Substantially Equivalent | CYNOSURE, INC. |
| K071734 | WATERLASE MD DERM | Jan 25, 2008 | Substantially Equivalent | BIOLASE TECHNOLOGY, INC. |
| K072833 | P-NAIN SYSTEM | Jan 24, 2008 | Substantially Equivalent | JEISYS MEDICAL, INC. |
| K072779 | CERALAS D 980NM DIODE LASER, MODELS D15 AND D25 | Jan 24, 2008 | Substantially Equivalent | BIOLITEC, INC. |
| K073496 | OPTILITE HOLMIUM LASER FIBERS | Jan 23, 2008 | Substantially Equivalent | COOK UROLOGICAL, INC. |
| K073464 | ANGIODYNAMICS, INC., NEVERTOUCH II 400UM FIBER AND VENACURE PROCEDURE KIT | Jan 23, 2008 | Substantially Equivalent | ANGIODYNAMICS, INC. |
| K072906 | SILK'N | Jan 23, 2008 | Substantially Equivalent | HOME SKINOVATIONS LTD. |
| K071883 | IPULSE, QUADRA Q4 PLATINUM SERIES, MODEL(S) 1200+SERIES 2, 1300 SERIES 2, Q4 SERIES 2 | Jan 23, 2008 | Substantially Equivalent | CYDEN LIMITED |
| K072925 | CANDELA-INOLASE SERENITY PRO PSF SYSTEM | Jan 10, 2008 | Substantially Equivalent | INOLASE, LTD. |
| K072332 | VARI-LASE WIRE FIBER | Jan 10, 2008 | Substantially Equivalent | VASCULAR SOLUTIONS, INC. |
| K072331 | RADIANCY MISTRAL DEVICE | Jan 07, 2008 | Substantially Equivalent | RADIANCY (ISRAEL) LTD. |
| K073313 | MARK III WAVEGUIDE FIBER WITH LOW PROFILE TIP | Jan 02, 2008 | Substantially Equivalent | OMNIGUIDE, INC. |
| K072751 | COOLTOUCH MODELS NS 160 AND LC215 COOLIPO | Jan 02, 2008 | Substantially Equivalent | NEW STAR LASERS, INC. |
| K073436 | SPECTRA VRMII 1-SWITCHED ND:YAG LASER SYSTEM | Dec 28, 2007 | Substantially Equivalent | LUTRONIC CORPORATION |
| K072484 | CYNOSURE YAG FAMILY LASER | Dec 27, 2007 | Substantially Equivalent | CYNOSURE, INC. |
| K072159 | SMART CO2 (SMARTXIDE, SMART US20D) WITH DOT SCANNER | Dec 27, 2007 | Substantially Equivalent | EL.EN. ELECTRONIC ENGINEERING SPA |
| K072995 | TWINWAVE DENTAL LASER, TIDALWAVE 810 DENTAL LASER, TIDALWAVE 980 DENTAL LASER | Dec 18, 2007 | Substantially Equivalent | LUMEN DEVELOPMENT AND MANUFACTURING, INC. |
| K073409 | OMNIGUIDE STERILE WAVEGUIDE ADAPTER SYSTEM | Dec 14, 2007 | Substantially Equivalent | OMNIGUIDE, INC. |
| K073394 | SMARTLIPO LASER | Dec 12, 2007 | Substantially Equivalent | CYNOSURE, INC. |
| K073300 | MILESMAN PREMIUM | Dec 04, 2007 | Substantially Equivalent | MILESMAN S.L. |
| K072344 | APL MEDICAL SYSTEM | Dec 03, 2007 | Substantially Equivalent | BIOS S.R.L. |
| K071815 | NOVEON, MODEL LS1100-01-0968 | Nov 28, 2007 | Substantially Equivalent | NOMIR MEDICAL TECHNOLOGIES, INC. |
| K072868 | ACCOLADE II LASER | Nov 05, 2007 | Substantially Equivalent | CYNOSURE, INC. |
| K071768 | ERBIUM FRACTIONAL HANDPIECE | Nov 05, 2007 | Substantially Equivalent | PALOMAR MEDICAL PRODUCTS, INC. |
| K071051 | FRAXEL III SR LASER SYSTEM AND ACCESSORIES | Nov 02, 2007 | Substantially Equivalent | RELIANT TECHNOLOGIES, INC. |
| K072262 | GENTLERAY 980 DIODE LASER SYSTEM | Oct 26, 2007 | Substantially Equivalent | KAVO AMERICA |
| K072767 | QUASAR BLUE LIGHT THERAPY SYSTEM | Oct 15, 2007 | Substantially Equivalent | SILVER BAY, LLC |
| K070870 | SKIN CARE LIGHT | Oct 10, 2007 | Substantially Equivalent | TRANSVERSE INDUSTRIES CO. |
| K071621 | RELIANT TECHNOLOGIES C300 CHILLER SYSTEM AND ACCESSORIES | Oct 09, 2007 | Substantially Equivalent | RELIANT TECHNOLOGIES, INC. |
| K072424 | COOLTOUCH, MODEL LC215,COOLLIPO | Oct 03, 2007 | Substantially Equivalent | NEW STAR LASERS, INC. |
| K070296 | VISIOLITE OPHTHALMIC ER: YAG LASER SYSTEM | Oct 03, 2007 | Substantially Equivalent | ACE VISION GROUP |
| K072514 | VISULAS TRION | Sep 21, 2007 | Substantially Equivalent | CARL ZEISS MEDITEC AG |
| K072034 | DIODE MEDICAL LASER FAMILY, MODELS 4, 6, 30 | Sep 20, 2007 | Substantially Equivalent | QUANTA SYSTEM, S.P.A. |
| K072023 | ELLIPSE JUVIA, MODEL 9EJU7465 | Sep 12, 2007 | Substantially Equivalent | ELLIPSE A/S |
| K071328 | VISUALASE THERMAL THERAPY SYSTEM | Aug 31, 2007 | Substantially Equivalent | BIOTEX, INC. |
| K072106 | 150W CERALAS D 980NM DIODE LASER | Aug 30, 2007 | Substantially Equivalent | BIOLITEC, INC. |
| K070185 | TANDA SKINCARE SYSTEM, PLC-001, TANDA BLUE, 414-001, TANDA RED, 660-001 | Aug 21, 2007 | Substantially Equivalent | PHAROS LIFE CORPORATION |
| K071469 | INOLASE SERENITY PSF ( PNEUMATIC SKIN FLATTENING) SYSTEM | Aug 15, 2007 | Substantially Equivalent | CANDELA CORP. |
| K071943 | SERENITY PRO PSF SYSTEM | Aug 10, 2007 | Substantially Equivalent | INOLASE 2002, LTD. |
| K071959 | ANGIODYNAMICS, INC.NEVERTOUCH 600UM FIBER AND VENACURE PROCEDURE KIT | Aug 01, 2007 | Substantially Equivalent | ANGIODYNAMICS, INC. |
| K071451 | TATTOOSTAR Y | Aug 01, 2007 | Substantially Equivalent | ASCLEPION LASER TECHNOLOGIES GMBH |
| K063427 | LUMINA INTENSE PULSED LIGHT (& LASER) SYSTEM | Jul 25, 2007 | Substantially Equivalent | LYNTON LASERS LIMITED |
| K070392 | MOSAIC LASER SYSTEM | Jul 13, 2007 | Substantially Equivalent | LUTRONIC CORPORATION |
| K070805 | ULTRAWAVE II EX 1320 | Jul 11, 2007 | Substantially Equivalent | QUANTA SYSTEM, S.P.A. |
| K070298 | MODIFICATION TO PALOMAR LUXIR HANDPIECE | Jul 03, 2007 | Substantially Equivalent | PALOMAR MEDICAL TECHNOLOGIES, INC. |
| K070924 | FLEXGUARD | Jun 21, 2007 | Substantially Equivalent | ALLMED SYSTEMS INC. |
| K071152 | PALOMAR ERBIUM HANDPIECE | May 25, 2007 | Substantially Equivalent | PALOMAR MEDICAL PRODUCTS, INC. |
| K070536 | MEDILAS D FAMILY LASERS | May 21, 2007 | Substantially Equivalent | DORNIER MEDTECH AMERICA, INC. |
| K070284 | FRALEX SR 1500 LASER SYSTEM (FRALEX II SR LASER SYSTEM) | May 17, 2007 | Substantially Equivalent | RELIANT TECHNOLOGIES, INC. |
| K071295 | 100W CERALAS D 980NM DIODE LASER | May 16, 2007 | Substantially Equivalent | BIOLITEC, INC. |
| K063104 | FOX MEDICAL DIODE LASER SYSTEM 810NM | May 16, 2007 | Substantially Equivalent | HOWARD INSTRUMENTS, INC. |
| K070388 | PROFILE MULTI-PLATFORM SYSTEM | May 02, 2007 | Substantially Equivalent | SCITON, INC. |
| K070353 | KELSEY INTERSITITAL LASER THERAPY SYSTEM | May 02, 2007 | Substantially Equivalent | KELSEY, INC. |
| K070494 | EPI-C PLUS | May 01, 2007 | Substantially Equivalent | ESPANSIONE MARKETING SPA |
| K063808 | FRAXEL IV SR LASER SYSTEM | Apr 27, 2007 | Substantially Equivalent | RELIANT TECHNOLOGIES, INC. |
| K063038 | FRAXEL III SR LASER SYSTEM AND ACCESSORIES | Apr 27, 2007 | Substantially Equivalent | RELIANT TECHNOLOGIES, INC. |
| K070466 | REVOLIX DUO LASER SYSTEM | Apr 17, 2007 | Substantially Equivalent | ALLMED SYSTEMS INC. |
| K062963 | PHAROS EXCIMER LASER SYSTEM, MODEL EX-308 | Apr 03, 2007 | Substantially Equivalent | RA MEDICAL SYSTEMS, INC. |
| K070138 | CUTERA ER:YAG LASER HANDPIECE | Mar 27, 2007 | Substantially Equivalent | CUTERA, INC. |
| K063867 | CUTERA ER:YSGG LASER HANDPIECE | Mar 27, 2007 | Substantially Equivalent | CUTERA, INC. |
| K070476 | REVOLIX 120 | Mar 26, 2007 | Substantially Equivalent | ALLMED SYSTEMS INC. |
| K062258 | GENESIS DIODE LASER | Mar 21, 2007 | Substantially Equivalent | IVOCLAR VIVADENT, INC. |
| K070216 | VARI-LASE BRIGHT TIP FIBER | Mar 16, 2007 | Substantially Equivalent | VASCULAR SOLUTIONS, INC. |
| K063384 | DIODENT MICRO DENTAL LASER SYSTEM, MODELS 810 AND 980 | Mar 16, 2007 | Substantially Equivalent | HOYA CONBIO, INC |
| K061489 | ATRILAZE MI SURGICAL ABLATION SYSTEM | Mar 16, 2007 | Substantially Equivalent | MEDICALCV, INC. |
| K070378 | ANGIODYNAMICS, INC. 600UM FIBER AND VENACURE PROCEDURE KIT | Mar 09, 2007 | Substantially Equivalent | ANGIODYNAMICS, INC. |
| K063152 | CLAROS DENTAL LASER SYSTEM | Mar 07, 2007 | Substantially Equivalent | ELEXXION AG |
| K063001 | SLIM EVOLUTION FAMILY OF CO2 LASERS AND DELIVERY DEVICE ACCESSORIES | Mar 07, 2007 | Substantially Equivalent | LASERING S.R.L. |
| K063698 | CO2 LASER SYSTEM, MODEL C-LAS | Mar 02, 2007 | Substantially Equivalent | CLINICON CORP. |
| K062762 | DERMA YAG | Mar 01, 2007 | Substantially Equivalent | EL.EN. ELECTRONIC ENGINEERING SPA |
| K061652 | PALOMAR LUX1540 HANDPIECE | Feb 27, 2007 | Substantially Equivalent | PALOMAR MEDICAL PRODUCTS, INC. |
| K063682 | INTRALASE FUSION LASER | Feb 09, 2007 | Substantially Equivalent | INTRALASE CORP. |
| K063571 | PALOMAR LUX2940 HANDPIECE | Feb 09, 2007 | Substantially Equivalent | PALOMAR MEDICAL TECHNOLOGIES, INC. |
| K063800 | CANDELA FLUORESCENT PULSED LIGHT SYSTEM | Feb 05, 2007 | Substantially Equivalent | CANDELA CORP. |
| K063715 | JUNIPER COOLING DEVICE XTRA | Feb 05, 2007 | Substantially Equivalent | JUNIPER MEDICAL INC. |
| K070157 | OMNIGUIDE BEAM PATH CO2 MARK III WAVEGUIDE FIBER | Feb 01, 2007 | Substantially Equivalent | OMNIGUIDE, INC. |
| K062303 | FRAXEL II SR LASER SYSTEM | Jan 31, 2007 | Substantially Equivalent | RELIANT TECHNOLOGIES, INC. |
| K061720 | COSMELIGHT | Jan 31, 2007 | Substantially Equivalent | PENNTACK ENTERPRISES INC. |
| K070063 | YAG MIR II LASER | Jan 30, 2007 | Substantially Equivalent | CYNOSURE, INC. |
| K061898 | EZLASE | Jan 26, 2007 | Substantially Equivalent | BIOLASE TECHNOLOGY, INC. |
| K070071 | OMNIGUIDE ZERO FLOW ZF-T WAVEGUIDE FIBER | Jan 25, 2007 | Substantially Equivalent | OMNIGUIDE, INC. |
| K063834 | REVLITE C6 Q-SWITCHED ND:YAG LASER SYSTEM | Jan 25, 2007 | Substantially Equivalent | HOYA CONBIO, INC |
| K063828 | DIOMED DELTA 25 | Jan 25, 2007 | Substantially Equivalent | DIOMED, LTD. |
| K063396 | VELURE FAMILY OF DIODE LASERS AND DELIVERY DEVICE ACCESSORIES | Jan 17, 2007 | Substantially Equivalent | LASERING S.R.L. |
| K063249 | BEAMAX | Jan 17, 2007 | Substantially Equivalent | MEDIC SHARPLIGHT LTD. |
| K062363 | BWF-5 MEDICAL LASER SERIES, 810 NM; 930 NM; 980 NM; 1080 NM | Jan 17, 2007 | Substantially Equivalent | B&W TEK, INC. |
| K063074 | CANDELA 3630 LASER SYSTEM | Dec 27, 2006 | Substantially Equivalent | CANDELA CORP. |
| K062314 | HORUS LASER KERATOME | Dec 22, 2006 | Substantially Equivalent | CARL ZEISS MEDITEC AG |
| K063073 | CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS | Dec 20, 2006 | Substantially Equivalent | CANDELA CORP. |
| K063072 | CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS: 532 AND 1064 ND:YAG HANDPIECE ACCESSORIES | Dec 20, 2006 | Substantially Equivalent | CANDELA CORP. |
| K061656 | LASER-D68 | Dec 15, 2006 | Substantially Equivalent | LASER PAIN CLINICS LP |
| K061436 | PALOMAR Q-YAG 5 ND:YAG LASER SYSTEM | Dec 06, 2006 | Substantially Equivalent | PALOMAR MEDICAL TECHNOLOGIES, INC. |
| K063112 | REVLITE Q-SWITCHED ND:YAG LASER | Dec 01, 2006 | Substantially Equivalent | HOYA CONBIO, INC |
| K062719 | GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIES | Dec 01, 2006 | Substantially Equivalent | LASERSCOPE |
| K062589 | SERENITY PSF (PNEUMATIC SKIN FLATTENING) SYSTEM | Nov 30, 2006 | Substantially Equivalent | INOLASE 2002, LTD. |
| K063141 | OMNIGUIDE ZERO FLOW ZF-T 150 WAVEGUIDE FIBER | Nov 29, 2006 | Substantially Equivalent | OMNIGUIDE, INC. |
| K063060 | BLUESHINE LIGHT SHINE SYSTEMS, SP, TWIN AND COMPACT SP | Nov 29, 2006 | Substantially Equivalent | BLUESHINE SRL |
| K062822 | VARI-LASE ENDOVENOUS LASER CONSOLE, MODEL 7500 | Nov 21, 2006 | Substantially Equivalent | VASCULAR SOLUTIONS, INC. |
| K062721 | GREENTON ECOLITE IPL SYSTEM | Nov 21, 2006 | Substantially Equivalent | GREENTON (LONDON) LTD. |
| K062871 | LUMACARE LC-122M NON-COHERENT LIGHT SOURCE | Nov 14, 2006 | Substantially Equivalent | LYNTON LASERS LIMITED |
| K062619 | DENLASER 800 PLUS | Nov 14, 2006 | Substantially Equivalent | CAO GROUP, INC. |
| K062369 | IRIDEX OCULIGHT TX | Nov 08, 2006 | Substantially Equivalent | IRIDEX CORP. |
| K062321 | SMARTLIPO ND:YAG LASER | Oct 31, 2006 | Substantially Equivalent | CYNOSURE, INC. |
| K060653 | THERMACLEAR | Oct 24, 2006 | Substantially Equivalent | DERMACARE, INC. |
| K062336 | OPTIMEDICA LASER INDIRECT OPHTHALMOSCOPE | Oct 19, 2006 | Substantially Equivalent | OPTIMEDICA CORPORATION |
| K062312 | AXIOM PULSED LIGHT SYSTEM | Oct 16, 2006 | Substantially Equivalent | GENERAL PROJECT S.R.L. |
| K061850 | MINI-YAG LASER | Sep 29, 2006 | Substantially Equivalent | AMERICAN LASERS, INC. |
| K062071 | PROMETEY, MODEL G1-03 | Sep 28, 2006 | Substantially Equivalent | SPECTRUM INTERNATIONAL |
| K061966 | LITETOUCH DENTAL LASER SYSTEM | Sep 27, 2006 | Substantially Equivalent | LIGHT INSTRUMENT LTD |
| K060787 | TATTOOSTAR FAMILY | Sep 27, 2006 | Substantially Equivalent | ASCLEPION LASER TECHNOLOGIES GMBH |
| K062210 | COOL TOUCH, MODELS CT3S, CTEV, NS160, CTEV, LC160 | Sep 25, 2006 | Substantially Equivalent | NEW STAR LASERS, INC. |
| K061618 | COOLTOUCH, MODEL CTEV | Sep 25, 2006 | Substantially Equivalent | NEW STAR LASERS, INC. |
| K062423 | OMNIGUIDE BEAMPATH LASER BEAM DELIVERY SYSTEM | Sep 21, 2006 | Substantially Equivalent | OMNIGUIDE, INC. |
| K062048 | AESTHERA PHOTOPNEUMATIC (PPX) SYSTEM | Sep 07, 2006 | Substantially Equivalent | AESTHERA CORPORATION |
| K053540 | INTERMEDIC DIODE LASER FAMILY 810NM AND 980NM (AND THE DELIVERY ACCESSORIES THAT ARE USED WITH THEM TO DELIVER LASER ENE | Sep 06, 2006 | Substantially Equivalent | INTERMEDIC ARFRAN, S.A. |
| K062248 | AZURYT MODEL CTL 1401, CO2 SURGICAL LASER SYSTEM | Aug 17, 2006 | Substantially Equivalent | NORTH AMERICAN CLINICAL LASERS, LTD. |
| K060372 | INTRALASE FS LASER, INTRALASE FS30 LASER, MODELS 1, 2, 3 | Aug 16, 2006 | Substantially Equivalent | INTRA LASE CORP. |
| K061455 | DORNIER MEDILAS H 20 LASER | Aug 01, 2006 | Substantially Equivalent | DORNIER MEDTECH AMERICA, INC. |
| K060966 | COOLTOUCH VARIA ND:YAG LASER SYSTEM | Jul 31, 2006 | Substantially Equivalent | COOLTOUCH, INC. |
| K061470 | DEL SOL BLUE LIGHT THERAPY SYSTEM | Jul 20, 2006 | Substantially Equivalent | EDGE SYSTEMS CORPORATION |
| K061909 | HIGHLAND BEAM DELIVERY SYSTEM, MODEL 3-099-002-00-00 | Jul 19, 2006 | Substantially Equivalent | OMNIGUIDE, INC. |
| K061366 | DENLASER 800 PLUS | Jul 10, 2006 | Substantially Equivalent | CAO GROUP, INC. |
| K060448 | LUMENIS ONE FAMILY OF SYSTEMS; LUMENIS ONE. | Jul 06, 2006 | Substantially Equivalent | LUMENIS LTD. |
| K052354 | OCULASE MD | Jul 05, 2006 | Substantially Equivalent | BIOLASE TECHNOLOGY, INC. |
| K061117 | NANOLITE SKIN CARE SYSTEM | Jun 20, 2006 | Substantially Equivalent | NANOLITE TECHNOLOGY, INC. |
| K061178 | ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT | Jun 12, 2006 | Substantially Equivalent | ANGIODYNAMICS, INC. |
| K060905 | IRIDEX OTOPROBE LONG AND SHORT ANGLES, P/N 14310-1 AND 14320-1 | May 31, 2006 | Substantially Equivalent | IRIDEX CORP. |
| K060407 | JUNIPER COOLING DEVICE | May 31, 2006 | Substantially Equivalent | JUNIPER MEDICAL TECHNOLOGY, INC |
| K060752 | ACMI DUR-HL LASER SYSTEMS | May 25, 2006 | Substantially Equivalent | ACMI CORPORATION |
| K060977 | MEDLITE C SERIES COMPRESSION TOOL AND HANDPIECE ATTACHMENT ACCESSORY, MODEL 659-0523 | May 24, 2006 | Substantially Equivalent | HOYA CONBIO, INC |
| K051442 | PHOTOSILK PLUS PULSED LIGHT SYSTEM AND LASER ATTACHMENT | May 24, 2006 | Substantially Equivalent | CYNOSURE, INC. |
| K060516 | ELLIPSE 12PL, MODEL 9ESL7228 | May 15, 2006 | Substantially Equivalent | DANISH DERMATOLOGIC DEVELOPMENT A/S |
| K052371 | DEPILITE EL-8B SERIES DERMO FLASH SYSTEMS | May 04, 2006 | Substantially Equivalent | HAIR INTERNATIONAL SYSTEMS USA, INC. |
| K060567 | SPECTRAGENICS ATS-1 | Apr 28, 2006 | Substantially Equivalent | SPECTRAGENICS, INC. |
| K060680 | ATRILAZE SURGICAL ABLATION SYSTEM | Apr 11, 2006 | Substantially Equivalent | MEDICALCV, INC. |
| K060114 | VECTRA LASER SYSTEM | Apr 07, 2006 | Substantially Equivalent | XINTEC CORPORATION, DBA, |
| K053628 | LIGHTSHEER DUET LASER SYSTEM | Apr 07, 2006 | Substantially Equivalent | LUMENIS, INC. |
| K060326 | LASERTX - DIODE LASER & DELIVERY SYSTEM | Apr 05, 2006 | Substantially Equivalent | PROSURG, INC. |
| K060310 | FRAXEL II SR LASER SYSTEM AND ACCESSORIES | Mar 29, 2006 | Substantially Equivalent | RELIANT TECHNOLOGIES, INC. |
| K060301 | PALOMAR LUX1540 HANDPIECE | Mar 23, 2006 | Substantially Equivalent | PALOMAR MEDICAL TECHNOLOGIES, INC. |
| K060411 | RADIANCY CLEARTOUCH LITE ACNE CLEARANCE SYSTEM | Mar 22, 2006 | Substantially Equivalent | RADIANCY (ISRAEL) LTD. |
| K060304 | PHOTEX DIODE LASER SERIES, MODELS 980, 810 AND 940 | Mar 21, 2006 | Substantially Equivalent | BIOTEX, INC. |
| K060459 | QUADROSTAR 980 | Mar 20, 2006 | Substantially Equivalent | ASCLEPION LASER TECHNOLOGIES GMBH |
| K060457 | QUADROSTAR 532 | Mar 20, 2006 | Substantially Equivalent | ASCLEPION LASER TECHNOLOGIES GMBH |
| K060455 | MULTISTAR | Mar 20, 2006 | Substantially Equivalent | ASCLEPION LASER TECHNOLOGIES GMBH |
| K053047 | FRAXEL SR LASER SYSTEM | Mar 20, 2006 | Substantially Equivalent | RELIANT TECHNOLOGIES, INC. |
| K060216 | ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM | Mar 16, 2006 | Substantially Equivalent | ENERGIST, LTD. |
| K052777 | LASEREX DUO FAMILY OF DUAL WAVELENGTH OPHTHALMIC LASERS INCLUDING MODELS INTEGRE DUO LP1RG-S, LP1RG-D | Mar 16, 2006 | Substantially Equivalent | Ellex Medical Pty. Ltd. |
| K060234 | MCCUE ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM | Mar 15, 2006 | Substantially Equivalent | MCCUE PLC |
| K052310 | CRYOFLOW 700, CRYOFLOW 1000 | Mar 15, 2006 | Substantially Equivalent | UNIPHY ELEKTROMEDIZIN GMBH & CO. KG |
| K053616 | POLARIS WR, ST APPLICATOR | Mar 14, 2006 | Substantially Equivalent | SYNERON MEDICAL LTD. |
| K053511 | DA VINCI FEMTOSECOND SURGICAL LASER | Mar 10, 2006 | Substantially Equivalent | SIE LTD SURGICAL INSTRUMENT ENGINEERING |
| K060338 | FAMILY OF SELECTA LASER SYSTEMS INCLUDING SELECTA 1064, SELECTA SLT, SELECTA DUET, SELECTA DUO, SELECTA TRIO | Mar 09, 2006 | Substantially Equivalent | LUMENIS, INC. |
| K060069 | PALOMAR LUXIR FRACTIONAL HANDPIECE | Mar 02, 2006 | Substantially Equivalent | PALOMAR MEDICAL TECHNOLOGIES, INC. |
| K053087 | VISUALASE COOLED LASER APPLICATOR SYSTEM, LASER DIFFUSING FIBER, COOLING CATHETER SYSTEM | Mar 01, 2006 | Substantially Equivalent | BIOTEX, INC. |
| K060033 | PROFILE MULTI-PLATFORM SYSTEM | Feb 28, 2006 | Substantially Equivalent | SCITON, INC. |
| K060395 | CRYO, MODEL V6.0 | Feb 24, 2006 | Substantially Equivalent | ZIMMER ELEKTROMEDIZIN GMBH |
| K053604 | WAVELIGHT IDAS | Feb 22, 2006 | Substantially Equivalent | WAVELIGHT LASER TECHNOLOGIE AG |
| K053139 | FOTONA QX ND:YAG/KTP LASER SYSTEM | Feb 16, 2006 | Substantially Equivalent | FOTONA D.D. |
| K053608 | CYNOSURE PHOTOGENICA V-STAR LASER | Feb 13, 2006 | Substantially Equivalent | CYNOSURE, INC. |
| K042114 | MDL SERIES DIODE LASERS, MODEL MDL-10/15 | Feb 03, 2006 | Substantially Equivalent | VISION LASERTECHNIK, GMBH |
| K053421 | YAG MIR FAMILY LASER | Feb 01, 2006 | Substantially Equivalent | CYNOSURE, INC. |
| K052991 | RADIANCY FACIAL SKINCARE DEVICE | Feb 01, 2006 | Substantially Equivalent | RADIANCY (ISRAEL) LTD. |
| K052442 | RADIANCY SKINSTATION WITH PSORIASIS LIGHT UNIT ASSEMBLY | Jan 26, 2006 | Substantially Equivalent | RADIANCY (ISRAEL) LTD. |
| K060050 | MEGABEAM SIDEFIBER FIBER OPTIC DELIVERY SYSTEM | Jan 23, 2006 | Substantially Equivalent | BIOLITEC, INC. |
| K052680 | CALCULASE HOLMIUM LASER SYSTEM AND ACCESSORIES | Jan 23, 2006 | Substantially Equivalent | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| K053161 | SIROLASER | Jan 18, 2006 | Substantially Equivalent | SIRONA DENTAL SYSTEMS GMBH |
| K053324 | CHROMOLITE SYSTEM | Jan 05, 2006 | Substantially Equivalent | CHROMOGENEX PLC |
| K051113 | QUANTA SYSTEM ETRNA GIOVINEZZA | Jan 04, 2006 | Substantially Equivalent | QUANTA SYSTEM, S.P.A. |
| K052848 | SPECTRA HAIR REMOVAL LASER | Dec 27, 2005 | Substantially Equivalent | SPECTRAGENICS, INC. |
| K053457 | VAPORMAX II | Dec 21, 2005 | Substantially Equivalent | TRIMEDYNE, INC. |
| K052604 | STARLITE 2006 | Dec 16, 2005 | Substantially Equivalent | LASER DENTAL INNOVATIONS |
| K052688 | ELLIPSE FLEX PPT, MODEL 9ESF7255 | Dec 12, 2005 | Substantially Equivalent | DANISH DERMATOLOGIC DEVELOPMENT A/S |
| K052874 | SOPRANO HAIR REMOVAL DIODE LASER | Nov 22, 2005 | Substantially Equivalent | MSQ (M2) LTD. |
| K052526 | NOVUS 3000 LASER SYSTEM AND DELIVERY DEVICES | Nov 15, 2005 | Substantially Equivalent | LUMENIS, INC. |
| K052806 | BURANE | Oct 17, 2005 | Substantially Equivalent | WAVELIGHT LASER TECHNOLOGIE AG |
| K052495 | ATRILAZE MALLEABLE ABLATION PROBE | Oct 11, 2005 | Substantially Equivalent | MEDICALCV, INC. |
| K052336 | SPECTRAQUATTRO PULSED LIGHT SYSTEM | Oct 11, 2005 | Substantially Equivalent | AMJET DISTRIBUTION, LLC |
| K051508 | MED FLASH II INTENSE PULSED LIGHT SYSTEM. | Oct 05, 2005 | Substantially Equivalent | GENERAL PROJECT S.R.L. |
| K051259 | VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100 | Sep 20, 2005 | Substantially Equivalent | THERALIGHT, INC. |
| K052324 | POLARIS LV, LVA APPLICATOR | Sep 14, 2005 | Substantially Equivalent | SYNERON MEDICAL LTD. |
| K050382 | AFFINITY QS Q-SWITCHED ND:YAG LASER SYSTEM | Sep 14, 2005 | Substantially Equivalent | CYNOSURE, INC. |
| K051876 | MULTIWAVE XR | Sep 09, 2005 | Substantially Equivalent | PACIFIC QUANTUM INSTRUMENTS, INC. |
| K051671 | RADIANCY SKINSTATION WITH MODIFIED LIGHT UNIT ADDEMBLY | Sep 02, 2005 | Substantially Equivalent | RADIANCY (ISRAEL) LTD. |
| K052129 | LUMENIS 1000 INTEGRATED SLIT LAMP | Aug 30, 2005 | Substantially Equivalent | LUMENIS, INC. |
| K051996 | DIOMED DELTA 15, MODEL DELTA 15; DIOMED DELTA 30, MODEL DELTA 30 | Aug 18, 2005 | Substantially Equivalent | DIOMED, LTD. |
| K050824 | 100W CERALAS D 980 LASER SYSTEM, MODEL D100 | Aug 10, 2005 | Substantially Equivalent | BIOLITEC, INC. |
| K051434 | COOLTOUCH ND:YAG LASER SYSTEMS, MODELS CT3S AND CTEV | Aug 09, 2005 | Substantially Equivalent | NEW STAR LASERS, INC. |
| K051428 | VTRAC EXCIMER LAMP SYSTEM | Aug 09, 2005 | Substantially Equivalent | PHOTO MEDEX, INC. |
| K050216 | OMNILUX REVIVE AND OMNILUX PLUS | Aug 09, 2005 | Substantially Equivalent | PHOTO THERAPEUTICS LIMITED |
| K051287 | VARI-LASE ENDOVENOUS LASER PROCEDURE KIT | Jul 29, 2005 | Substantially Equivalent | VASCULAR SOLUTIONS, INC. |
| K041893 | INTRALASE FS LASER | Jul 29, 2005 | Substantially Equivalent | INTRALASE CORP. |
| K043032 | DEALIGHT IPL | Jul 19, 2005 | Substantially Equivalent | EUROPRO, INC. |
| K051359 | CANDELA FAMILY OF PULSED DYE LASER SYSTEMS: PIGMENTED LESION HANDPIECE ACCESSORY | Jul 13, 2005 | Substantially Equivalent | CANDELA CORP. |
| K051268 | RADIANCE ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT | Jul 06, 2005 | Substantially Equivalent | RADIANCY, LTD. |
| K050841 | FRAXEL SR LASER SYSTEM | Jul 05, 2005 | Substantially Equivalent | RELIANT TECHNOLOGIES, INC. |
| K051255 | LUMIPHASE-R | Jul 01, 2005 | Substantially Equivalent | OPUSMED INC. |
| K051399 | WAVELIGHT AURIGA | Jun 30, 2005 | Substantially Equivalent | WAVELIGHT LASER TECHNOLOGIE AG |
| K050779 | CYNERGY MULTIPLEX LASER | Jun 27, 2005 | Substantially Equivalent | CYNOSURE, INC. |
| K042630 | REVLIGHT SKIN CARE SYSTEM | Jun 27, 2005 | Substantially Equivalent | SKINCARE TECHNOLOGY INC. |
| K050696 | MEDLITE C1 Q-SWITCHED ND:YAG LASER | Jun 17, 2005 | Substantially Equivalent | HOYA PHOTONICS, INC. |
| K050673 | CANDELA FAMILY OF PULSE DYE LASER SYSTEMS | Jun 13, 2005 | Substantially Equivalent | CANDELA CORP. |
| K050738 | FT FIBER OPTIC DELIVERY SYSTEMS | Jun 02, 2005 | Substantially Equivalent | FIBERTECH GMBH |
| K051167 | REVOLIX AND REVOLIX JR | Jun 01, 2005 | Substantially Equivalent | ALLMED SYSTEMS INC. |
| K043377 | ZENO | Jun 01, 2005 | Substantially Equivalent | TYRELL, INC. |
| K050453 | ODYSSEY 2.4G, DENLASER ELITE, MODEL 002-00050 | May 27, 2005 | Substantially Equivalent | IVOCLAR VIVADENT, INC. |
| K050900 | MEDIOSTAR XT | May 16, 2005 | Substantially Equivalent | ASCLEPION LASER TECHNOLOGIES GMBH |
| K050672 | ERCHONIA EVRL LASER | May 02, 2005 | Substantially Equivalent | ERCHONIA MEDICAL, INC. |
| K050950 | MODELS CRYSTAL 512, RECORD 618, OPTIMA 518 PHOTO EPILATION SYSTEMS | Apr 29, 2005 | Substantially Equivalent | ACTIVE OPTICAL SYSTEMS, LTD./EFRAIM BIDAS |
| K050274 | DIODENT II DENTAL LASER SYSTEM | Apr 29, 2005 | Substantially Equivalent | HOYA PHOTONICS, INC. |
| K041554 | AIP INTENSE PULSED LIGHT SYSTEM | Apr 27, 2005 | Substantially Equivalent | AESTHERA CORPORATION |
| K050165 | MODIFICATION TO IFL PROFESSIONAL SYSTEM, MODEL C100 | Apr 19, 2005 | Substantially Equivalent | CYDEN LIMITED |
| K050254 | SPECTRA-SP CO2 LASER SYSTEM | Apr 15, 2005 | Substantially Equivalent | MAX ENGINEERING LTD. |
| K050562 | OCULIGHT GL/GLX | Apr 14, 2005 | Substantially Equivalent | IRIDEX CORP. |
| K050796 | AURORA DS, DS APPLICATOR | Apr 12, 2005 | Substantially Equivalent | SYNERON MEDICAL LTD. |
| K050679 | CUTERA SOLERA OPUS AESTHETIC PRODUCT | Mar 31, 2005 | Substantially Equivalent | CUTERA, INC. |
| K050047 | CUTERA OPTIONAL PULSED LIGHT HAND PIECE FAMILY | Mar 31, 2005 | Substantially Equivalent | CUTERA, INC. |
| K043521 | BIOSYAG 50 MED | Mar 24, 2005 | Substantially Equivalent | BIOS S.R.L. |
| K050293 | FOTONA XP PLUS ND: YAG FAMILY OF LASER SYSTEMS, FONTONA DUALIS XP PLUS ND: YAG FAMILY OF LASER SYSTEMS | Mar 18, 2005 | Substantially Equivalent | FOTONA D.D. |
| K050021 | VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT | Mar 18, 2005 | Substantially Equivalent | VASCULAR SOLUTIONS, INC. |
| K043329 | OMNILUX REVIVE AND BLUE | Mar 18, 2005 | Substantially Equivalent | PHOTO THERAPEUTICS LIMITED |
| K050412 | VAPORMAX | Mar 14, 2005 | Substantially Equivalent | TRIMEDYNE, INC. |
| K050108 | SUREFLEX AND ACCUFLEX LASER LITHOTRIPSY FIBERS | Mar 14, 2005 | Substantially Equivalent | INNOVAQUARTZ |
| K042319 | RELIANT LASER II SYSTEM AND ACCESSORIES | Mar 10, 2005 | Substantially Equivalent | RELIANT TECHNOLOGIES, INC. |
| K050452 | AURORA SR AND SRA APPLICATOR | Mar 09, 2005 | Substantially Equivalent | SYNERON MEDICAL LTD. |
| K043486 | PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01 | Mar 03, 2005 | Substantially Equivalent | TOPCON MEDICAL LASER SYSTEMS, INC |
| K050317 | BURANE XL | Feb 24, 2005 | Substantially Equivalent | WAVELIGHT LASER TECHNOLOGIE AG |
| K043575 | DERMILLUME, MODEL PRO1000 | Feb 24, 2005 | Substantially Equivalent | CARE ELECTRONICS, INC. |
| K043255 | ELLIPSE LIGHT SPT | Feb 24, 2005 | Substantially Equivalent | DANISH DERMATOLOGIC DEVELOPMENT A/S |
| K050218 | WAVELIGHT SINON | Feb 15, 2005 | Substantially Equivalent | WAVELIGHT LASER TECHNOLOGIE AG |
| K043251 | CANDELA FAMILY OF PULSED DYE LASER SYSTEMS, MODELS VBEAM, CBEAM, SPTL-1B | Feb 09, 2005 | Substantially Equivalent | CANDELA CORP. |
| K043046 | COOLTOUCH, MODEL CT3S | Feb 01, 2005 | Substantially Equivalent | NEW STAR LASERS, INC. |
| K050069 | CUTERA FLASHLAMP TABLETOP AESTHETIC PRODUCT | Jan 31, 2005 | Substantially Equivalent | CUTERA, INC. |
| K043173 | Q-SWITCHED ND:YAG LASER TREATMENT HEAD FOR THE LUMENIS QUANTUM SERIES | Jan 31, 2005 | Substantially Equivalent | LUMENIS, LTD. |
| K040103 | SOUNDSKIN PHOTOTHERAPY SYSTEM | Jan 18, 2005 | Substantially Equivalent | BHC INTERNATIONAL, LTD. |
| K041879 | PALOMAR LUX1064 HANDPIECE | Jan 13, 2005 | Substantially Equivalent | PALOMAR MEDICAL TECHNOLOGIES, INC. |
| K041086 | PALOMAR STARLUX PULSED LIGHT SYSTEM | Jan 13, 2005 | Substantially Equivalent | PALOMAR MEDICAL PRODUCTS, INC. |
| K043429 | CYNERGY LASER | Jan 12, 2005 | Substantially Equivalent | CYNOSURE, INC. |
| K042000 | MODIFIED MSQ FAMILY OF LOVELY LIGHT/LASER SYSTEMS | Dec 21, 2004 | Substantially Equivalent | MSQ (M2) LTD. |
| K043319 | CLAREON AND SOLARUS PULSED LIGHT DEVICES AND ACCESSORIES | Dec 17, 2004 | Substantially Equivalent | NOVALIS MEDICAL, LLC |
| K040270 | OPUSDUO; OPUSDUO E; OPUSDUO EC; OPUS 20; OPUS SPECTRUM | Dec 16, 2004 | Substantially Equivalent | LUMENIS LTD. |
| K031425 | GENTLEWAVES LED PHOTOMODULATION DEVICE | Dec 15, 2004 | Substantially Equivalent | LIGHT BIOSCIENCE, LLC |
| K042785 | MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300 | Dec 14, 2004 | Substantially Equivalent | NIDEK, INC. |
| K041011 | ULTRALIGHT II ND:YAG LASER SYSTEM | Dec 14, 2004 | Substantially Equivalent | SANDSTONE MEDICAL TECHNOLOGIES, LLC |
| K043164 | PANALIGHT-BLU, MODEL 4175 | Dec 10, 2004 | Substantially Equivalent | DUSA PHARMACEUTICALS, INC. |
| K041957 | EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERS | Dec 01, 2004 | Substantially Equivalent | DIOMED, INC. |
| K040744 | ATRILAZE SOFT TISSUE ABLATION SYSTEM | Nov 30, 2004 | Substantially Equivalent | MEDICALCV, INC. |
| K042968 | MCL 30 DERMABLATE ER:YAG LASER SYSTEM | Nov 24, 2004 | Substantially Equivalent | ASCLEPION LASER TECHNOLOGIES GMBH |
| K042918 | MICROPROBE LASER AND ENDOSCOPY SYSTEM, MODEL E2 | Nov 22, 2004 | Substantially Equivalent | ENDO OPTIKS, INC. |
| K041242 | CANDELA SMOOTHBEAM LASER SYSTEM | Nov 22, 2004 | Substantially Equivalent | CANDELA CORP. |
| K043012 | OMNIPULSE MINI, MODEL 2120 | Nov 17, 2004 | Substantially Equivalent | TRIMEDYNE, INC. |
| K041323 | PULSED LIGHT THERAPY SYSTEM, MODEL PRIMA | Nov 17, 2004 | Substantially Equivalent | NEW STAR LASERS, INC. |
| K042211 | MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SYSTEMS | Nov 08, 2004 | Substantially Equivalent | SURGICAL LASER TECHNOLOGIES, INC. |
| K041959 | POLARIS DS/COMET | Nov 08, 2004 | Substantially Equivalent | SYNERON MEDICAL LTD. |
| K042496 | ADEPT ULTRALITE 532 LASER | Nov 02, 2004 | Substantially Equivalent | ADEPT MEDICAL CONCEPTS |
| K041969 | AURORA DS | Oct 19, 2004 | Substantially Equivalent | SYNERON MEDICAL LTD. |
| K041943 | XTRAC XL, MODEL AL8000 | Oct 14, 2004 | Substantially Equivalent | PHOTO MEDEX, INC. |
| K040563 | LS FAMILY OF CO2 LASERS INCLUDING: LS-15 LASER SYSTEM (15 WATT) AND LS-25 LASER SYSTEM (25 WATT) | Oct 08, 2004 | Substantially Equivalent | SANDSTONE MEDICAL TECHNOLOGIES, LLC |
| K042439 | AZURYT MODEL CLT 1401, CO2 SURGICAL LASER SYSTEM | Oct 07, 2004 | Substantially Equivalent | DIAMOND AGE SYSTEMS, INC. |
| K041994 | MULTICLEAR XL MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM | Oct 06, 2004 | Substantially Equivalent | CURELIGHT LTD |
| K041767 | COOLCUBE COOLPEN | Sep 30, 2004 | Substantially Equivalent | BRUCE J. SAND M.D. |
| K042474 | ARION | Sep 29, 2004 | Substantially Equivalent | WAVELIGHT LASER TECHNOLOGIE AG |
| K041739 | EDWARDS E360 SURGICAL ABLATION DEVICE | Sep 29, 2004 | Substantially Equivalent | EDWARDS LIFESCIENCES, LLC. |
| K040921 | COOLTOUCH, MODEL NS 160 | Sep 28, 2004 | Substantially Equivalent | COOLTOUCH, INC. |
| K032991 | LIGHT AGE EPICARE ALEXANDRITE LASER, MODELS 501-1H, 501-SP, 501-LP AND 501-LPX | Sep 14, 2004 | Substantially Equivalent | LIGHT AGE, INC. |
| K041930 | VARILITE LASER SYSTEM | Sep 10, 2004 | Substantially Equivalent | IRIDEX CORPORATION |
| K042139 | VISULAS YAG III | Sep 09, 2004 | Substantially Equivalent | CARL ZEISS MEDITEC AG |
| K041660 | TRIMEDYNE HOLMIUM LASER SYSTEMS | Sep 08, 2004 | Substantially Equivalent | TRIMEDYNE, INC. |
| K041829 | FOCUS MEDICAL NATURALASE LP AND NATURALIGHT FAMILY OF PRODUCTS | Sep 07, 2004 | Substantially Equivalent | FOCUS MEDICAL, LLC. |
| K041419 | LIGHTFORCE LF 20/30 980NM SURGICAL DIODE LASER SYSTEM | Aug 26, 2004 | Substantially Equivalent | MEDICAL ENERGY, INC. |
| K041262 | DURALITE-GL | Aug 13, 2004 | Substantially Equivalent | LASER SCIENTIFIC |
| K041721 | LVI AESTHETIC LASER | Aug 05, 2004 | Substantially Equivalent | HOYA PHOTONICS, INC. |
| K041710 | VERSAWAVE DENTAL ER:YAG LASER SYSTEM | Aug 03, 2004 | Substantially Equivalent | HOYA CONBIO |
| K041103 | ACNELIFT | Jul 27, 2004 | Substantially Equivalent | INNER ACT, LLC |
| K030290 | PERIOLASE ND:YAG DENTAL LASER SYSTEM | Jul 26, 2004 | Substantially Equivalent | MILLENNIUM DENTAL TECHNOLOGIES, INC. |
| K031140 | WATERLASE | Jul 07, 2004 | Substantially Equivalent | BIOLASE TECHNOLOGY, INC. |
| K041569 | CLEAR100 PHOTOTHERAPY SYSTEM, MODEL FGCM0002 | Jun 30, 2004 | Substantially Equivalent | CURELIGHT LTD |
| K040617 | RELIANT LASER SYSTEM II | Jun 15, 2004 | Substantially Equivalent | RELIANT TECHNOLOGIES, INC. |
| K040659 | MCCUE PLC ENERGIST ULTRA VARIABLE PULSED LIGHT SYSTEM | Jun 01, 2004 | Substantially Equivalent | MCCUE PLC |
| K032397 | DUAL YELLOW LASER, MODEL DUAL YELLOW D10B | May 27, 2004 | Substantially Equivalent | NORSELD PTY., LTD. |
| K041095 | PHOTOSILK PULSED LIGHT SYSTEM | May 26, 2004 | Substantially Equivalent | CYNOSURE, INC. |
| K040433 | SINON | May 19, 2004 | Substantially Equivalent | WAVELIGHT LASER TECHNOLOGIE AG |
| K040384 | MYDON C | May 14, 2004 | Substantially Equivalent | WAVELIGHT LASER TECHNOLOGIE AG |
| K040424 | LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY KIT, MODEL 1120 | May 11, 2004 | Substantially Equivalent | CLARUS MEDICAL, LLC. |
| K040294 | LASERPRO DIODE LASER SYSTEMS, MODELS 810, 940 & 980 | May 05, 2004 | Substantially Equivalent | PHOTOMEDEX, INC. |
| K030810 | COOLAN 300 | May 05, 2004 | Substantially Equivalent | COOLANALGESIA LTD. |
| K040289 | SMARTLITE D FREQUENCY DOUBLED ND:YAG LASER | Apr 30, 2004 | Substantially Equivalent | CYNOSURE, INC. |
| K040727 | CRYO 5 | Apr 23, 2004 | Substantially Equivalent | ZIMMER ELEKTROMEDIZIN GMBH |
| K040131 | COOLTOUCH; COOLTOUCH II; AND COOLTOUCH CT3 ND:YAG LASER SYSTEM | Apr 20, 2004 | Substantially Equivalent | NEW STAR LASERS, INC. |
| K033183 | RECLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0012 | Apr 15, 2004 | Substantially Equivalent | CURELIGHT LTD |
| K040055 | POLYLASE LP | Apr 07, 2004 | Substantially Equivalent | DDC TECHNOLOGIES, INC. |
| K032797 | DELIGHT DENTAL ER: YAG LASER SYSTEM | Apr 05, 2004 | Substantially Equivalent | HOYA PHOTONICS, INC. |
| K040234 | LASERPRO CO2 CARBON DIOXIDE LASER SYSTEM | Apr 02, 2004 | Substantially Equivalent | PHOTOMEDEX, INC. |
| K040081 | PALOMAR LUXV HANDPIECE | Apr 01, 2004 | Substantially Equivalent | PALOMAR MEDICAL TECHNOLOGIES, INC. |
| K033072 | LUCENTLITE, MODEL IMD 010 | Apr 01, 2004 | Substantially Equivalent | INDUSTRIAL & MEDICAL DESIGN, INC. |
| K034011 | GEMINI SURGICAL LASER SYSTEM & ACCESSORIES | Mar 30, 2004 | Substantially Equivalent | LASERSCOPE |
| K040005 | PROFILE 2000/3000 LASER SYSTEM | Mar 29, 2004 | Substantially Equivalent | SCITON, INC. |
| K040156 | IFL PROFESSIONAL SYSTEM, MODEL C100 | Mar 24, 2004 | Substantially Equivalent | CYDEN LIMITED |
| K032864 | CERALAS D 810 DIODE LASER SYSTEM, MODEL D15 | Mar 19, 2004 | Substantially Equivalent | BIOLITEC, INC. |
| K032863 | CERALAS D 980 DIODE LASER SYSTEM, MODELS D15, D25, D50 | Mar 19, 2004 | Substantially Equivalent | BIOLITEC, INC. |
| K033933 | POWERLITE 600 EX SYSTEM | Mar 16, 2004 | Substantially Equivalent | PRESWEDE AB |
| K033549 | STARLUX PULSED LIGHT SYSTEM | Mar 10, 2004 | Substantially Equivalent | PALOMAR MEDICAL PRODUCTS, INC. |
| K032459 | PROFILE 1320 LASER SYSTEM | Mar 09, 2004 | Substantially Equivalent | SCITON, INC. |
| K033251 | THE FRIENDLYLIGHT ND: YAG LASERS | Mar 02, 2004 | Substantially Equivalent | INNOTECH USA, INC. |
| K033259 | LIGHT AGE Q-CLEAR LASER, MODEL 701-1101 | Feb 25, 2004 | Substantially Equivalent | LIGHT AGE, INC. |
| K033962 | LAD (EPITURE EASYTOUCH), MODEL LAD-08 | Feb 20, 2004 | Substantially Equivalent | NORWOOD ABBEY , LTD. |
| K033354 | FEMTEC LASER MICROKERATOME | Feb 18, 2004 | Substantially Equivalent | 20/10 PERFECT VISION OPTISCHE GERATE GMBH |
| K034030 | APOGEE ELITE | Feb 09, 2004 | Substantially Equivalent | CYNOSURE, INC. |
| K030523 | WATERLASE | Jan 30, 2004 | Substantially Equivalent | BIOLASE TECHNOLOGY, INC. |
| K032514 | AC APPLICATOR, AURORA AC | Jan 27, 2004 | Substantially Equivalent | SYNERON MEDICAL LTD. |
| K032667 | FOCUS MEDICAL 532 HAND PIECE ADAPTER AND DYE PACK ACCESSORIES (RED OR YELLOW) | Jan 23, 2004 | Substantially Equivalent | FOCUS MEDICAL, LLC. |
| K033176 | TRISTAR AESTHETIC WORKSTATION LASER | Jan 21, 2004 | Substantially Equivalent | CYNOSURE, INC. |
| K033437 | SPHINX LASER SYSTEMS | Jan 20, 2004 | Substantially Equivalent | ALLMED SYSTEMS INC. |
| K033461 | CANDELA VBEAM PULSE DYE LASER SYSTEM | Jan 16, 2004 | Substantially Equivalent | CANDELA CORP. |
| K033331 | CANDELA CBEAM PULSE DYE LASER SYSTEM | Jan 16, 2004 | Substantially Equivalent | CANDELA CORP. |
| K033423 | REVOLIX LASER SYSTEMS | Jan 15, 2004 | Substantially Equivalent | ALLMED SYSTEMS INC. |
| K033799 | CLINICAL LASETTE P-200 | Dec 22, 2003 | Substantially Equivalent | CELL ROBOTICS, INC. |
| K032944 | YA-MAN LASER 21 | Dec 19, 2003 | Substantially Equivalent | YA-MAN LTD |
| K032846 | SPECTRA PULSED DIODE LASER, MODEL DR-1 | Dec 11, 2003 | Substantially Equivalent | SPECTRAGENICS, INC. |
| K032205 | RADIANCY ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT ASSEMBLY | Dec 11, 2003 | Substantially Equivalent | RADIANCY (ISRAEL) LTD. |
| K033586 | MODIFICATION TO AURORA DS | Dec 10, 2003 | Substantially Equivalent | SYNERON MEDICAL LTD. |
| K032735 | SPECTRA QT: Q-SWITCHED ND: YAG LASER SYSTEM | Dec 03, 2003 | Substantially Equivalent | MAX ENGINEERING LTD. |
| K030834 | CANDELA SMOOTHBEAM LASER SYSTEM | Dec 03, 2003 | Substantially Equivalent | CANDELA CORP. |
| K031671 | POLARIS WR | Dec 01, 2003 | Substantially Equivalent | SYNERON MEDICAL LTD. |
| K032383 | MULTICLEAR MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM | Nov 28, 2003 | Substantially Equivalent | CURELIGHT LTD |
| K033237 | VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER CONSOLE | Nov 20, 2003 | Substantially Equivalent | VASCULAR SOLUTIONS, INC. |
| K032260 | ARAMIS II DERMATOLOGICAL LASER | Nov 20, 2003 | Substantially Equivalent | QUANTEL MEDICAL |
| K032539 | CYNOSURE PHOTOGENICA SV LASER | Nov 17, 2003 | Substantially Equivalent | CYNOSURE, INC. |
| K024206 | AURA ISURGICAL LASER SYSTEM & ACCESSORIES | Nov 17, 2003 | Substantially Equivalent | LASERSCOPE |
| K032460 | PROFILE BBL SYSTEM | Nov 13, 2003 | Substantially Equivalent | SCITON, INC. |
| K031795 | RELIANT LASER SYSTEM | Nov 10, 2003 | Substantially Equivalent | RELIANT TECHNOLOGIES, INC. |
| K033172 | CANDELA GENTLEYAG FAMILY OF LASER SYSTEMS | Oct 30, 2003 | Substantially Equivalent | CANDELA CORP. |
| K031819 | DIO-DENT 10 DENTAL DIODE LASER | Oct 30, 2003 | Substantially Equivalent | MSQ (M2) LTD. |
| K032599 | MEDICAL LASER TECHNOLOGIES, LLC MTL ERBIUM:YAG LASER SYSTEM | Oct 29, 2003 | Substantially Equivalent | MEDICAL LASER TECHNOLOGIES, LLC |
| K033181 | SPR SYSTEM | Oct 24, 2003 | Substantially Equivalent | RADIANCY (ISRAEL) LTD. |
| K032704 | INNOVATECH ILLUMINATING LASER PROBE, MODEL 420-30 | Oct 24, 2003 | Substantially Equivalent | INNOVATECH SURGICAL INC. |
| K032703 | INNOVATECH STRAIGHT LASER PROBE, MODEL 420-10 | Oct 24, 2003 | Substantially Equivalent | INNOVATECH SURGICAL INC. |
| K032221 | ADEPT 1064/755 LASER | Oct 24, 2003 | Substantially Equivalent | ADEPT MEDICAL CONCEPTS |
| K032220 | ADEPT 1064/532 LASER | Oct 24, 2003 | Substantially Equivalent | ADEPT MEDICAL CONCEPTS |
| K032218 | ADEPT 1064/532/755 LASER | Oct 24, 2003 | Substantially Equivalent | ADEPT MEDICAL CONCEPTS |
| K032565 | CYNOSURE PHOTOGENICA VL | Oct 22, 2003 | Substantially Equivalent | CYNOSURE, INC. |
| K030539 | LASERSMILE | Oct 10, 2003 | Substantially Equivalent | BIOLASE TECHNOLOGY, INC. |
| K032357 | NOVUS TTX LASER AND DELIVERY DEVICES WITH ACCESSORIES | Oct 09, 2003 | Substantially Equivalent | LUMENIS, INC. |
| K031125 | CYNOSURE SMART FILE ND:YAG LASERS | Oct 09, 2003 | Substantially Equivalent | CYNOSURE, INC. |
| K032085 | GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000 | Oct 03, 2003 | Substantially Equivalent | NIDEK, INC. |
| K032805 | MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT | Oct 01, 2003 | Substantially Equivalent | VASCULAR SOLUTIONS, INC. |
| K032023 | W.O.M. LASER U100PLUS | Oct 01, 2003 | Substantially Equivalent | W.O.M. WORLD OF MEDICINE AG |
| K031440 | SMART CO2 (SMART US 20D, SMART CLINIC) SURGICAL LASER | Oct 01, 2003 | Substantially Equivalent | CYNOSURE, INC. |
| K031389 | CYNOSURE SMART 2940D ER:YAG LASER | Oct 01, 2003 | Substantially Equivalent | CYNOSURE, INC. |
| K031960 | INTRALASE FS LASER | Sep 29, 2003 | Substantially Equivalent | INTRALASE CORP. |
| K030846 | CANDELA SMOOTHBEAM LASER SYSTEM | Sep 16, 2003 | Substantially Equivalent | CANDELA CORP. |
| K031805 | BLU-U, MODEL 4170 | Sep 09, 2003 | Substantially Equivalent | DUSA PHARMACEUTICALS, INC. |
| K031954 | COOLTOUCH INCORPORATED MODELCT3 ND:YAG SURGICAL LASER SYSTEMS | Aug 21, 2003 | Substantially Equivalent | NEW STAR LASERS, INC. |
| K032204 | MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT | Aug 20, 2003 | Substantially Equivalent | VASCULAR SOLUTIONS, INC. |
| K032191 | OMNILIGHT FLUORESCENT PULSED LIGHT SYSTEM | Aug 20, 2003 | Substantially Equivalent | LUXSANO AB |
| K031489 | PITANGA | Aug 19, 2003 | Substantially Equivalent | SYNERON MEDICAL LTD. |
| K031993 | AURORA SR | Aug 01, 2003 | Substantially Equivalent | SYNERON MEDICAL LTD. |
| K031988 | AURORA DS | Aug 01, 2003 | Substantially Equivalent | SYNERON MEDICAL LTD. |
| K031451 | XTRACXL PLUS EXCIMER LASER SYSTEM, MODEL AL7000 | Aug 01, 2003 | Substantially Equivalent | PHOTO MEDEX, INC. |
| K030033 | LUMENIS FAMILY OF DISPOSABLE CONTACT TIP DELIVERY DEVICES | Jul 21, 2003 | Substantially Equivalent | LUMENIS, LTD. |
| K030426 | OMNILUX RED | Jul 17, 2003 | Substantially Equivalent | PHOTO THERAPEUTICS LIMITED |
| K030342 | LUMENIS FAMILY OF IPL SYSTEMS AND COMBINATION IPL/ND:YAG SYSTEMS | Jul 17, 2003 | Substantially Equivalent | LUMENIS, LTD. |
| K031690 | CYNOSURE YAG FAMILY LASER (PHOTOGENICA YAG AND ACCLAIM) | Jul 08, 2003 | Substantially Equivalent | CYNOSURE, INC. |
| K031258 | CYNOSURE PHOTOLIGHT PL | Jul 08, 2003 | Substantially Equivalent | CYNOSURE, INC. |
| K024204 | FOTONA FIDELIS PLUS ND:YAG LASER SYSTEM | Jul 07, 2003 | Substantially Equivalent | FOTONA D.D. |
| K031680 | SPECTRAPULSE | Jun 24, 2003 | Substantially Equivalent | PRIMARY TECHNOLOGY, LLC. |
| K024259 | PULSED LIGHT THERAPY SYSTEM, MODEL# UV-300 | Jun 20, 2003 | Substantially Equivalent | NEW STAR LASERS, INC. |
| K024189 | NLITE SYSTEM, MODEL#: A00-1025/A00-1033 | Jun 20, 2003 | Substantially Equivalent | ICN PHOTONICS LTD. |
| K030897 | SKINSTATION | Jun 19, 2003 | Substantially Equivalent | RADIANCY (ISRAEL) LTD. |
| K024093 | MODIFIED LUMENIS FAMILY OF INTENSE PULSED-LIGHT (IPL) AND COMBINATION IPL SYSTEMS AND ND:YAG LASER SYSTEMS | Jun 19, 2003 | Substantially Equivalent | LUMENIS, LTD. |
| K031233 | ANDIODYNAMICS, INC. ELVS PROCEDURE KIT | Jun 18, 2003 | Substantially Equivalent | ANGIODYNAMICS, INC. |
| K030883 | OMNILUX BLUE | Jun 18, 2003 | Substantially Equivalent | PHOTO THERAPEUTICS LIMITED |
| K030654 | VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT | Jun 18, 2003 | Substantially Equivalent | VASCULAR SOLUTIONS, INC. |
| K023881 | PROFILE 1064 LASER SYSTEM | Jun 13, 2003 | Substantially Equivalent | SCITON, INC. |
| K031488 | CYNOSURE APOGEE-TKS II DERMATOLOGICAL LASER | Jun 04, 2003 | Substantially Equivalent | CYNOSURE, INC. |
| K030700 | CERALAS D 10-60 810NM LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT | Jun 04, 2003 | Substantially Equivalent | BIOLITEC, INC. |
| K031317 | SMART 2940 D ER: YAG LASER | May 22, 2003 | Substantially Equivalent | CYNOSURE, INC. |
| K031184 | COOL TOUCH 3 | May 21, 2003 | Substantially Equivalent | NEW STAR LASERS, INC. |
| K030805 | MYTHOS 500 | May 21, 2003 | Substantially Equivalent | MSQ (M2) LTD. |
| K030527 | LUMENIS FAMILY OF IPL AND COMBINATION IPL/ND:YAG SYSTEMS | May 20, 2003 | Substantially Equivalent | LUMENIS |
| K030508 | DEPILASE TRIO LASE LASER SYSTEM | May 20, 2003 | Substantially Equivalent | DEPILASE GROUP LTD. |
| K030510 | DEPILASE TWIN YAG LASER SYSTEM | May 14, 2003 | Substantially Equivalent | DEPILASE GROUP LTD. |
| K030480 | L600 HAIR REMOVAL | May 14, 2003 | Substantially Equivalent | A&M TECHNOLOGY |
| K030453 | COOLTOUCH ND: YAG LASER SYSTEM | May 12, 2003 | Substantially Equivalent | NEW STAR LASERS, INC. |
| K031224 | SMARTXIDE | May 09, 2003 | Substantially Equivalent | CYNOSURE, INC. |
| K030506 | DEPILASE YAG LASE PLUS LASER SYSTEM | May 09, 2003 | Substantially Equivalent | DEPILASE GROUP LTD. |
| K030423 | POWERLITE 600 EP SYSTEM | May 09, 2003 | Substantially Equivalent | PRESWEDE AB |
| K023734 | ARAMIS II DERMATOLOGICAL LASER | May 06, 2003 | Substantially Equivalent | QUANTEL MEDICAL |
| K030959 | BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100 | Apr 25, 2003 | Substantially Equivalent | LASER PERIPHERALS LLC. |
| K030235 | F1 DIODE LASER SYSTEM | Apr 23, 2003 | Substantially Equivalent | OPUS MEDICAL, INC. |
| K030181 | INTERNATIONAL BIOPHYSICS CORPORATION (IBC) LASER PEEL SYSTEM | Apr 17, 2003 | Substantially Equivalent | INTERNATIONAL BIOPHYSICS CORP. |
| K030147 | LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS | Apr 15, 2003 | Substantially Equivalent | LUMENIS, LTD. |
| K023547 | DIOLASE 980 D LASER SYSTEM | Apr 15, 2003 | Substantially Equivalent | AMERICAN DENTAL TECHNOLOGIES, INC. |
| K030186 | POLRIS LV | Apr 14, 2003 | Substantially Equivalent | SYNERON MEDICAL LTD. |
| K024371 | CANDELA GENTLE LASE FAMILY OF LASER SYSTEM | Mar 31, 2003 | Substantially Equivalent | CANDELA CORP. |
| K023257 | ENDOSCOPIC LASER DELIVERY SYSTEM-LASERTX | Mar 28, 2003 | Substantially Equivalent | PROSURG, INC. |
| K024260 | CANDELA GENTLELASE FAMILY OF LASER SYSTEMS | Mar 21, 2003 | Substantially Equivalent | CANDELA CORP. |
| K023954 | ALTUS MEDICAL COOLGLIDE LASER SYSTEMS AND ACCESSORIES | Mar 18, 2003 | Substantially Equivalent | ALTUS MEDICAL, INC. |
| K022923 | CANDELA GENTLE YAG LASER SYSTEM | Mar 13, 2003 | Substantially Equivalent | CANDELA CORP. |
| K024335 | CANDELA GENTLELASE FAMILY OF LASER SYSTEMS | Mar 12, 2003 | Substantially Equivalent | CANDELA CORP. |
| K024061 | PEREGRINE STRAIGHT LASER PROBE, MODEL PD6000.00 | Mar 07, 2003 | Substantially Equivalent | PEREGRINE SURGICAL LTD. |
| K023899 | DUAL YELLOW LASER, MODEL D10B | Feb 20, 2003 | Substantially Equivalent | NORSELD PTY., LTD. |
| K022709 | MEDLITE Q-SWITHCED LASER | Feb 20, 2003 | Substantially Equivalent | CONTINUUM ELECTRO-OPTICS, INC. |
| K030338 | ICLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0002 | Feb 12, 2003 | Substantially Equivalent | CURELIGHT LTD |
| K024064 | POLARIS DS | Feb 10, 2003 | Substantially Equivalent | SYNERON MEDICAL LTD. |
| K022807 | MELADINE NATURAL MELANIN ENHANCER, PRODUCT NUMBER CT81602AA | Jan 29, 2003 | Substantially Equivalent | CREATIVE TECHNOLOGIES, INC. |
| K023967 | PALOMAR Q-YAG ND:YAG LASER SYSTEM | Jan 27, 2003 | Substantially Equivalent | PALOMAR MEDICAL TECHNOLOGIES, INC. |
| K023624 | SLT VENOUS FIBER DELIVERY SYSTEMS, MODEL: 0041-6772/0041-6781/0041-6752/0041-6761/0041-6912/0041-6921 | Jan 27, 2003 | Substantially Equivalent | SURGICAL LASER TECHNOLOGIES, INC. |
| K022951 | CANDELA GENTLE YAG LASER SYSTEM, VARIABLE PULSE YAG | Jan 27, 2003 | Substantially Equivalent | CANDELA CORP. |
| K022341 | TERABYTE 2000 HAIR REMOVER | Jan 27, 2003 | Substantially Equivalent | TERABYTE CO. |
| K022884 | CANDELA SMOOTHBEAM LASER SYSTEM | Jan 22, 2003 | Substantially Equivalent | CANDELA CORP. |
| K023464 | VIRIDIS TWIN OPHTHALMIC PHOTOCOAGULATOR | Jan 13, 2003 | Substantially Equivalent | QUANTEL MEDICAL |
| K021222 | LAD, MODEL LAD-01 | Jan 08, 2003 | Substantially Equivalent | NORWOOD ABBEY , LTD. |
| K024088 | CERALAS D 980 LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT, MODEL: D15 AND D25 | Jan 02, 2003 | Substantially Equivalent | BIOLITEC, INC. |
| K022466 | PROFILE 1320 LASER SYSTEM | Dec 31, 2002 | Substantially Equivalent | SCITON, INC. |
| K023962 | NEW STAR LASERS, INC. DOVE ND: YAG LASER SYSTEM, MODEL: NS-160 | Dec 24, 2002 | Substantially Equivalent | NEW STAR LASERS, INC. |
| K023193 | CANDELA GENTLE YAG LASER SYSTEM | Dec 20, 2002 | Substantially Equivalent | CANDELA CORP. |
| K022607 | SPECTRAPULSE | Dec 20, 2002 | Substantially Equivalent | PRIMARY TECHNOLOGY, LLC. |
| K023081 | PROLITE / PLASMALITE MPX PULSED LIGHT SYSTEM (PERMANENT HAIR REDUCTION) | Dec 16, 2002 | Substantially Equivalent | MEDICAL BIO CARE SWEDEN AB |
| K023041 | W.O.M. LASER U100 | Dec 11, 2002 | Substantially Equivalent | W.O.M. WORLD OF MEDICINE AG |
| K021548 | FOTONA DUALIS ND:YAG/ER:YAG LASER SYSTEM | Dec 06, 2002 | Substantially Equivalent | FOTONA D.D. |
| K023543 | EVLT KIT AND D15PLUS AND D30PLUS DIODE | Dec 02, 2002 | Substantially Equivalent | DIOMED, INC. |
| K022839 | FOTONA DUALIS PLUS ND:YAG LASER SYSTEM | Nov 25, 2002 | Substantially Equivalent | FOTONA D.D. |
| K022838 | FOTONA DUALIS ER:YAG/KTP LASER SYSTEM | Nov 25, 2002 | Substantially Equivalent | FOTONA D.D. |
| K022837 | FOTONA TANDEM LASER SYSTEM | Nov 25, 2002 | Substantially Equivalent | FOTONA D.D. |
| K022817 | COOLTOUCH ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH-II | Nov 22, 2002 | Substantially Equivalent | ICN PHARMACEUTICALS, INC. |
| K022464 | EQUILASE SYSTEM | Nov 21, 2002 | Substantially Equivalent | EQUILASERS, INC |
| K021444 | CYNOSURE PHOTOGENICA SV | Nov 20, 2002 | Substantially Equivalent | CYNOSURE, INC. |
| K022760 | MILLENNIUM MICROSURGICAL SYSTEM | Nov 18, 2002 | Substantially Equivalent | BAUSCH & LOMB, INC. |
| K022655 | TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATH | Nov 07, 2002 | Substantially Equivalent | TRIMEDYNE, INC. |
| K022610 | CLARUS STRAIGHT FIRING LASER FIBER, MODEL 1150, CLARUS SIDE FIRING LASER FIBER, MODEL 1160 | Nov 05, 2002 | Substantially Equivalent | CLARUS MEDICAL, LLC. |
| K022583 | FLASH 1 | Oct 31, 2002 | Substantially Equivalent | EMED, INC. |
| K022060 | LUMENIS ULTRAPULSE ENCORE CARBON DIOXIDE SURGICAL LASERS AND DELIVERY DEVICE ACCESSORIES | Oct 30, 2002 | Substantially Equivalent | LUMENIS, INC. |
| K020339 | DORNIER DIODE LASER FAMILY MEDILAS D, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEM | Oct 25, 2002 | Substantially Equivalent | DORNIER MEDTECH AMERICA, INC. |
| K023182 | INDIGO OPTIMA LASER SYSTEM, OPTIMA DIFFUSER-TIP FIBEROPTIC-BPH, OPTIMA BARE-TIP FIBEROPTIC,OPTIMA LASER CART WITH PRINTS | Oct 24, 2002 | Substantially Equivalent | ETHICON ENDO-SURGERY, INC. |
| K022381 | PROFILE 1320 LASER SYSTEM | Oct 18, 2002 | Substantially Equivalent | SCITON, INC. |
| K022378 | PLASMALITE PULSED LIGHT SYSTEM | Oct 18, 2002 | Substantially Equivalent | MEDICAL BIO CARE SWEDEN AB |
| K022351 | DIODENT DENTAL LASER SYSTEM | Oct 16, 2002 | Substantially Equivalent | CONTINUUM ELECTRO-OPTICS, INC. |
| K022338 | OPTICAL INTEGRITY GENERAL SHAPED FIBER | Oct 16, 2002 | Substantially Equivalent | OPTICAL INTEGRITY, INC. |
| K022327 | NOVUS SPECTRA | Oct 16, 2002 | Substantially Equivalent | LUMENIS, INC. |
| K020839 | QUANTUM, MODELS SR, HR, DL; VASCULIGHT, MODELS SR, HR, VS, VX, DL | Oct 11, 2002 | Substantially Equivalent | LUMENIS, INC. |
| K022228 | FAMILY OF IRIS MEDICAL ENDOPROBE HANDPIECES | Oct 08, 2002 | Substantially Equivalent | IRIDEX CORP. |
| K022226 | ALTUS MEDICAL FAMILY OF COOLGLIDE LASERS, MODELS COOLGLIDE I, COOLGLIDE II, AND FUTURE MODELS | Oct 08, 2002 | Substantially Equivalent | ALTUS MEDICAL, INC. |
| K014128 | CANDELA SMOOTHBEAM LASER SYSTEM | Oct 04, 2002 | Substantially Equivalent | CANDELA CORP. |
| K022266 | AURORA SR | Oct 03, 2002 | Substantially Equivalent | SYNERON MEDICAL LTD. |
| K022181 | NOVUS VARIA OPHTHALMIC LASER AND DELIVERY DEVICES WITH ACCESSORIES | Oct 01, 2002 | Substantially Equivalent | LUMENIS, INC. |
| K013974 | RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30; N/A 1500-A | Sep 23, 2002 | Substantially Equivalent | TRIMEDYNE, INC. |
| K021975 | LASERSYSTEM BEAUTYSTAR 532 | Sep 13, 2002 | Substantially Equivalent | ASCLEPION-MEDITEC AG |
| K021946 | CELL ROBOTICS ULTRA-LIGHT PEEL LASER SYSTEM | Sep 11, 2002 | Substantially Equivalent | CELL ROBOTICS, INC. |
| K021848 | CLARUS STRAIGHT FIRING LASER FIBER; CLARUS SIDE FIRING LASER FIBER; MODELS 1150, 1160 | Sep 03, 2002 | Substantially Equivalent | CLARUS MEDICAL, LLC. |
| K022569 | PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF VASCULAR LESIONS | Aug 29, 2002 | Substantially Equivalent | MEDICAL BIO CARE SWEDEN AB |
| K022568 | PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF UNWANTED HAIR | Aug 29, 2002 | Substantially Equivalent | MEDICAL BIO CARE SWEDEN AB |
| K022544 | DORNIER MEDILAS H LASER FIBER CABLES | Aug 21, 2002 | Substantially Equivalent | DORNIER MEDTECH AMERICA, INC. |
| K021696 | 20G SMA LASER FIBER, MODEL LF20; 25G SMA LASER FIBER, MODEL LF25 | Aug 20, 2002 | Substantially Equivalent | OPHTHALMED LLC |
| K021686 | LASER FIBER GF500 | Aug 20, 2002 | Substantially Equivalent | W.O.M. WORLD OF MEDICINE AG |
| K021724 | DORNIER DIODE LASER FAMILY, INCLUDING MEDILAS D FIBERTOM, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEMS | Aug 19, 2002 | Substantially Equivalent | DORNIER MEDTECH AMERICA, INC. |
| K021650 | ATHOSCAN FOR THE ATHOS LASER CONSTANS COOLING HAND PIECE FOR THE ATHOS LASER | Aug 16, 2002 | Substantially Equivalent | QUANTEL MEDICAL |
| K013623 | CLEARLIGHT PHOTOTHERAPHY SYSTEM, MODEL CL 420 | Aug 16, 2002 | Substantially Equivalent | CURELIGHT LTD |
| K013691 | CERALAS D DIODE LASER SYSTEM, MODEL # D50 | Aug 13, 2002 | Substantially Equivalent | BIOLITEC, INC. |
| K021550 | LUMENIS SELECTA DUET | Aug 09, 2002 | Substantially Equivalent | Ellex Medical Pty. Ltd. |
| K021508 | OPUSDUO EC DENTAL LASER SYSTEM | Aug 07, 2002 | Substantially Equivalent | OPUSDENT LTD. |
| K021304 | PROLITE PULSED LIGHT SYSTEM | Jul 23, 2002 | Substantially Equivalent | BIG SKY LASER TECHNOLOGIES, INC. |
| K021616 | DELIGHT DENTAL ER: YAG LASER SYSTEM | Jul 11, 2002 | Substantially Equivalent | CONTINUUM ELECTRO-OPTICS, INC. |
| K021149 | AURORA DS | Jul 09, 2002 | Substantially Equivalent | SYNERON MEDICAL LTD. |
| K021180 | CANDELA VBEAM PULSED DYE LASER SYSTEM | Jul 02, 2002 | Substantially Equivalent | CANDELA CORP. |
| K020021 | LYRA SURGICAL LASER SYSTEM AND ACCESSIORIES (ND:YAG CONFIGURATION) | Jul 02, 2002 | Substantially Equivalent | LASERSCOPE |
| K021227 | SOFTLASE G2-SURGICAL DIODE LASER SYSTEM | Jun 26, 2002 | Substantially Equivalent | ZAP LASERS, LLC |
| K020958 | CANDELA CBEAM PULSED DYE LASER SYSTEM | Jun 21, 2002 | Substantially Equivalent | CANDELA CORP. |
| K020941 | PALOMAR LUXG HANDPIECE | Jun 19, 2002 | Substantially Equivalent | PALOMAR |
| K020856 | SPATOUCH PHOTOEPILATION SYSTEM | Jun 13, 2002 | Substantially Equivalent | RADIANCY (ISRAEL) LTD. |
| K020835 | CERALAS D10-60 810NM DIODE LASER, MODELCERALAS DIO-60 | Jun 12, 2002 | Substantially Equivalent | BIOLITEC, INC. |
| K020729 | NLITE SYSTEM,MODEL A00-1051 | Jun 04, 2002 | Substantially Equivalent | ICN PHOTONICS LTD. |
| K014040 | FAMILY OF ALTUS MEDICAL MODIFIED COOLGLIDE AESTHETIC LASERS, MODELS COOLGLIDE I, II AND FUTURE MODELS | Jun 03, 2002 | Substantially Equivalent | ALTUS MEDICAL, INC. |
| K020673 | WAVE FORM MANUFACTURING PROLASE GENERAL SHAPED FIBER | May 30, 2002 | Substantially Equivalent | WAVE FORM MFG., INC. |
| K013021 | LIGHTLANCE LASER SKIN PERFORATOR | May 30, 2002 | Substantially Equivalent | INNOTECH USA, INC. |
| K020849 | APEX 800 LASER SYSTEM, MODEL APEX 800 | May 20, 2002 | Substantially Equivalent | IRIDEX CORP. |
| K020847 | XTRAC EXCIMER LASER SYSTEM, MODEL AL7000 | May 16, 2002 | Substantially Equivalent | PHOTO MEDEX, INC. |
| K020513 | EPY-50 | May 16, 2002 | Substantially Equivalent | DDC TECHNOLOGIES, INC. |
| K020453 | PALOMAR ESTELUX PULSED LIGHT SYSTEM AND PALOMAR COOLROLLER | May 10, 2002 | Substantially Equivalent | PALOMAR MEDICAL TECHNOLOGIES, INC. |
| K013300 | MAXIFLEX FIBER OPTIC ENERGY DELIVERY SYSTEM | Apr 16, 2002 | Substantially Equivalent | TECHNOLOGY DELIVERY SYSTEMS, INC. |
| K020697 | DEPILASE TWIN YAG LASER SYSTEM | Apr 12, 2002 | Substantially Equivalent | DEPILASE GROUP LTD. |
| K020099 | MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE | Apr 11, 2002 | Substantially Equivalent | BIOLITEC, INC. |
| K020072 | ATHOS LASER | Apr 09, 2002 | Substantially Equivalent | QUANTEL MEDICAL |
| K020071 | VIRIDIS DERMA LASER | Apr 05, 2002 | Substantially Equivalent | QUANTEL MEDICAL |
| K020973 | EX-308 EXCIMER LASER FOR PHOTOTHERAPY TREATMENT OF VITILIGO | Mar 29, 2002 | Substantially Equivalent | SURGILIGHT, INC. |
| K014272 | PERIOLASE ND:YAG DENTAL LASER SYSTEM | Mar 27, 2002 | Substantially Equivalent | MILLENNIUM DENTAL TECHNOLOGIES, INC. |
| K014253 | DERMACHILLER 4 | Mar 26, 2002 | Substantially Equivalent | PARADIGM TREX, LLC |
| K014236 | CLINICON WAVEGUIDE PLATFORM WITH INTERCONNECT FOR LUXAR ACCESSORIES | Mar 26, 2002 | Substantially Equivalent | CLINICON CORP. |
| K013201 | CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR | Mar 18, 2002 | Substantially Equivalent | CARDIOFOCUS, INC. |
| K014057 | DERMASTAR ER:YAG LASER SYSTEM | Mar 08, 2002 | Substantially Equivalent | ASCLEPION-MEDITEC AG |
| K014035 | COOLTOUCH AND COOLTOUCH-II ND:YAG LASER SYSTEMS | Mar 07, 2002 | Substantially Equivalent | COOLTOUCH CORP. |
| K020463 | DEPILASE YAG LASE PLUS LASER SYSTEM | Feb 27, 2002 | Substantially Equivalent | DEPILASE GROUP LTD. |
| K013941 | PULSION FS LASER KERATOME | Feb 27, 2002 | Substantially Equivalent | INTRALASE CORP. |
| K013216 | DIODENT DENTAL LASER SYSTEM | Feb 27, 2002 | Substantially Equivalent | CONTINUUM ELECTRO-OPTICS, INC. |
| K013940 | LASER SYSTEM YELLOWSTAR | Feb 26, 2002 | Substantially Equivalent | ASCLEPION-MEDITEC AG |
| K020412 | DEPILASE TWIN LASE LASER SYSTEM | Feb 22, 2002 | Substantially Equivalent | DEPILASE GROUP LTD. |
| K013825 | CANDELA SMOOTHBEAM LASER SYSTEM | Feb 15, 2002 | Substantially Equivalent | CANDELA CORP. |
| K014048 | CLINICON UNIVERSAL WAVEGUIDE HANDPIECE AND FIBER TIPS | Feb 11, 2002 | Substantially Equivalent | CLINICON CORP. |
| K013748 | CANDELA SCLERO LONG PULSE LASER (AKA VBEAM) | Feb 11, 2002 | Substantially Equivalent | CANDELA CORP. |
| K013864 | MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-60 | Feb 08, 2002 | Substantially Equivalent | NIDEK, INC. |
| K020107 | SMARTEPIL | Feb 07, 2002 | Substantially Equivalent | CYNOSURE, INC. |
| K012398 | DIOMED 15 DIODE LASER | Jan 22, 2002 | Substantially Equivalent | DIOMED, LTD. |
| K014234 | MEDLITE IV Q-SWITCHEDND: YAGLASER REPLACED BY THE MEDLITE C6 Q-SWICTHED ND: YAG LASER | Jan 17, 2002 | Substantially Equivalent | CONTINUUM ELECTRO-OPTICS, INC. |
| K013461 | NLITE SYSTEM,MODEL A00-1025 | Jan 17, 2002 | Substantially Equivalent | ICN PHOTONICS LTD. |
| K014130 | NLITE SYSTEM | Jan 08, 2002 | Substantially Equivalent | ICN PHOTONICS LTD. |
| K014100 | OPUS SPECTRUM (A MODEL OF OPUS 20), MODEL 2ND | Jan 08, 2002 | Substantially Equivalent | OPUSDENT LTD. |
| K013366 | PROLITE PULSED LIGHT SYSTEM FOR THE REMOVAL OF UNWANTED HAIR | Jan 08, 2002 | Substantially Equivalent | MEDICAL BIO CARE SWEDEN AB |
| K013365 | PROLITE PULSED LIGHT SYSTEM FOR THE TREATMENT OF PIGMENTED LESIONS AND THE REMOVAL OF TATTOOS | Jan 08, 2002 | Substantially Equivalent | MEDICAL BIO CARE SWEDEN AB |
| K011939 | FOTONA DUALIS, FOTONA DUALIS PLUS | Dec 27, 2001 | Substantially Equivalent | FOTONA D.D. |
| K013193 | MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE | Dec 21, 2001 | Substantially Equivalent | BIOLITEC, INC. |
| K011960 | LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS POCKETPRO OR POCKETPRO S4) | Dec 21, 2001 | Substantially Equivalent | LARES RESEARCH, INC. |
| K013901 | MALLEABLE SURGICAL LIGHTSTIC 180, MODEL 180 (1CM-9CM) | Dec 20, 2001 | Substantially Equivalent | CARDIOFOCUS, INC. |
| K013493 | INDIGO OPTIMA LASER SYSTEM | Dec 13, 2001 | Substantially Equivalent | ETHICON ENDO-SURGERY, INC. |
| K013047 | FOTONA DUALIS ND:YAG LASER SYSTEM, FOTONA TWINLIGHT ND:YAG LASER SYSTEM | Dec 06, 2001 | Substantially Equivalent | MOJCA VALIJAVEC |
| K013028 | PALOMAR SLP 1000 | Dec 06, 2001 | Substantially Equivalent | PALOMAR MEDICAL PRODUCTS, INC. |
| K012071 | ENT LASERVISION | Dec 03, 2001 | Substantially Equivalent | UNION MEDICAL USA |
| K010771 | PERIOLASE ND:YAG DENTAL LASER SYSTEM | Nov 27, 2001 | Substantially Equivalent | MILLENNIUM DENTAL TECHNOLOGIES, INC. |
| K012806 | CYNOSURE PHOTOGENICA VL | Nov 19, 2001 | Substantially Equivalent | CYNOSURE, INC. |
| K011322 | DORNIER SAPPHIREERBIUM HANDPIECE, DORNIER SAPPHIRESPOT HANDPIECE | Nov 19, 2001 | Substantially Equivalent | DORNIER MEDTECH AMERICA, INC. |
| K013499 | DIOMED 15 PLUS AND DIOMED 30PLUS LASERS | Nov 16, 2001 | Substantially Equivalent | DIOMED, INC. |
| K012790 | CYNOSURE PHOTOGENICA ER | Nov 16, 2001 | Substantially Equivalent | CYNOSURE, INC. |
| K013402 | VISULAS 532S | Nov 14, 2001 | Substantially Equivalent | CARL ZEISS, INC. |
| K012682 | REPROCESSED LASER PROBE | Nov 08, 2001 | Substantially Equivalent | STERILMED, INC. |
| K011174 | PARADIGM-FONTONA PEROVSKITE ND: YAP LASER SYSTEM AND ACCESSORIES | Nov 07, 2001 | Substantially Equivalent | FOTONA D.D. |
| K011070 | DRT4 LASER DOPPLER PERFUSION AND TEMPERATURE MONITOR | Nov 07, 2001 | Substantially Equivalent | MOOR INSTRUMENTS LTD. |
| K012552 | SCITON IMAGE HAIR REMOVAL LASER | Nov 05, 2001 | Substantially Equivalent | SCITON, INC. |
| K012545 | ARAMIS DERMATLOGIC LASER | Nov 05, 2001 | Substantially Equivalent | LUMEDICS, LTD. |
| K011175 | W.O.M. LASER U100 | Nov 01, 2001 | Substantially Equivalent | W.O.M. WORLD OF MEDICINE, GMBH |
| K013043 | CANDELA CLEARBEAM PULSED DYE LASER | Oct 11, 2001 | Substantially Equivalent | CANDELA CORP. |
| K011021 | LASER 20 | Oct 09, 2001 | Substantially Equivalent | YA-MAN LTD |
| K012127 | PULSEMASTER ERBIUM DENTAL LASER SYSTEM | Oct 04, 2001 | Substantially Equivalent | AMERICAN DENTAL TECHNOLOGIES, INC. |
| K010804 | MEGABEAM/CERALAS REUSEABLE HANDPIECE AND DISPOSABLE TIPS | Oct 04, 2001 | Substantially Equivalent | BIOLITEC, INC. |
| K010715 | AL-40 | Oct 04, 2001 | Substantially Equivalent | DDC TECHNOLOGIES, INC. |
| K012982 | COOLTOUCH VARIZOOM | Oct 02, 2001 | Substantially Equivalent | NEW STAR LASERS, INC. |
| K010618 | PALOMAR DERMALUX PULSED LIGHT SYSTEM | Sep 10, 2001 | Substantially Equivalent | PALOMAR |
| K011828 | CYNOSURE ACCLAIM DERMATOLOGY LASER | Sep 07, 2001 | Substantially Equivalent | CYNOSURE, INC. |
| K011769 | OPUS 10 (WITH TOOTH WHITENING APPLICATION), MODEL 2ND | Aug 30, 2001 | Substantially Equivalent | OPUSDENT LTD. |
| K011747 | PALOMAR LC 100 DIODE LASER | Aug 30, 2001 | Substantially Equivalent | PALOMAR MEDICAL TECHNOLOGIES, INC. |
| K011703 | LUMENIS VERSAPULSE POWERSUITE HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) SURGICAL LASERS AND DELIVERY DEVICES | Aug 29, 2001 | Substantially Equivalent | LUMENIS |
| K002890 | INTRALASE 600C LASER KERATOME | Aug 09, 2001 | Substantially Equivalent | INTRALASE CORP. |
| K011423 | INPULSE DENTAL LASER | Aug 07, 2001 | Substantially Equivalent | INCISIVE, LLC. |
| K011382 | XTRAC EXCIMER LASER SYSTEM, MODEL AL 7000 | Aug 02, 2001 | Substantially Equivalent | PHOTO MEDEX, INC. |
| K011207 | LASER PERIPHERALS REUSABLE HOLMIUM FIBER | Jul 24, 2001 | Substantially Equivalent | LASER PERIPHERALS, LLC. |
| K011092 | CANDELA SPTL-1E PULSED DYE LASER | Jul 09, 2001 | Substantially Equivalent | CANDELA CORP. |
| K011041 | WATERLASE, MILLENNIUM | Jul 03, 2001 | Substantially Equivalent | BIOLASE TECHNOLOGY, INC. |
| K011677 | MEDLITE Q-SWITCHED ND:YAG LASER REPLACED BY THE MEDLITE C3 Q-SWTICHED ND:YAG LASER | Jun 22, 2001 | Substantially Equivalent | CONTINUUM ELECTRO-OPTICS, INC. |
| K010928 | PROLITE VL PULSED LIGHT SYSTEM | Jun 19, 2001 | Substantially Equivalent | MEDICAL BIO CARE SWEDEN AB |
| K010927 | MODIFICATION TO PROLITE PULSED LIGHT SYSTEM | Jun 19, 2001 | Substantially Equivalent | MEDICAL BIO CARE SWEDEN AB |
| K011409 | SLT LASERPRO CTH HOLMIUM LASER SYSTEM | Jun 14, 2001 | Substantially Equivalent | SURGICAL LASER TECHNOLOGIES, INC. |
| K010885 | UNI-LASER 470 | Jun 07, 2001 | Substantially Equivalent | MEDART CORP. |
| K010580 | PALOMAR SLP 1000 | May 22, 2001 | Substantially Equivalent | PALOMAR MEDICAL TECHNOLOGIES, INC. |
| K003318 | PHOTON MULTI-PLATFORM SYSTEM, MODEL Z-12834-X & Z-13175-X | May 22, 2001 | Substantially Equivalent | PARADIGM MEDICAL INDUSTRIES, INC. |
| K010834 | LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES | May 21, 2001 | Substantially Equivalent | LASERSCOPE |
| K010689 | MEGABEAM/CERALAS NON STERILE FIBER OPTIC LASER DELIVERY SYSTEMS, MODEL 200,320,400 OR 600UM | May 18, 2001 | Substantially Equivalent | BIOLITEC, INC. |
| K010316 | COOLTOUCH VARIA ND:YAG LASER SYSTEM; COOLTOUCH VARIA-II ND:YAG LASER SYSTEM | May 01, 2001 | Substantially Equivalent | COOLTOUCH CORP. |
| K010284 | LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION) | May 01, 2001 | Substantially Equivalent | LASERSCOPE |
| K003440 | SOFTLASE - SURGICAL DIODE LASER SYSTEM | Apr 20, 2001 | Substantially Equivalent | ZAP LASERS, INC. |
| K010113 | LASER MECHANISMS LASER SCANNING SYSTEM | Apr 12, 2001 | Substantially Equivalent | LASER MECHANISMS, INC. |
| K010104 | CANDELA LONG PULSE ND:YAG | Apr 11, 2001 | Substantially Equivalent | CANDELA CORP. |
| K010046 | NUVOLASE 532 MEDICAL LASER SYSTEM | Apr 05, 2001 | Substantially Equivalent | AMERICAN LASER CORP. |
| K010005 | CYNOSURE PHOTOGENICA DL | Apr 02, 2001 | Substantially Equivalent | CYNOSURE, INC. |
| K004039 | CYNOSURE PHOTOGENICA NEO-V | Mar 29, 2001 | Substantially Equivalent | CYNOSURE, INC. |
| K004021 | F1 DIODE LASER SYSTEM | Mar 27, 2001 | Substantially Equivalent | OPUS MEDICAL, INC. |
| K004006 | SELECTA 7000 FREQUENCY DOUBLED, Q-SWITCHED ND:YAG OPHTHALMIC LASER | Mar 26, 2001 | Substantially Equivalent | LUMENIS, INC. |
| K003993 | DORNIER MEDILAS D SKINPULSE LASER SYSTEM (SKINPULSE) | Mar 26, 2001 | Substantially Equivalent | DORNIER SURGICAL PRODUCTS, INC. |
| K004014 | MD 30 COMPACT | Mar 16, 2001 | Substantially Equivalent | GENERAL PROJECT |
| K003953 | INDIGO DIFFUSER-TIP FIBEROPTIC WITH TEMPERATURE SENSING OPTION, MODEL LF001 | Mar 16, 2001 | Substantially Equivalent | ETHICON ENDO-SURGERY, INC. |
| K003952 | INDIGO LASEROPTIC TREATMENT SYSTEM | Mar 16, 2001 | Substantially Equivalent | ETHICON ENDO-SURGERY, INC. |
| K003955 | LASEREX INTEGRE, MODEL LP2532 | Mar 15, 2001 | Substantially Equivalent | Ellex Medical Pty. Ltd. |
| K003614 | LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM | Mar 13, 2001 | Substantially Equivalent | COHERENT STAR |
| K010041 | SLT DIFFUSER FIBER | Mar 07, 2001 | Substantially Equivalent | SURGICAL LASER TECHNOLOGIES, INC. |
| K003765 | LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION) | Mar 06, 2001 | Substantially Equivalent | LASERSCOPE |
| K010285 | CONTOUR PROFILE LASER | Mar 01, 2001 | Substantially Equivalent | SCITON, INC. |
| K003886 | PALOMAR SPALIGHT PULSED LIGHT SYSTEM | Mar 01, 2001 | Substantially Equivalent | PALOMAR MEDICAL TECHNOLOGIES, INC. |
| K003715 | COOLTOUCH ND:YAG LASER SYSTEM, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH II | Mar 01, 2001 | Substantially Equivalent | COOLTOUCH CORP. |
| K003705 | XTRAC EXCIMER LASER SYSTEM, MODEL AL7000 | Mar 01, 2001 | Substantially Equivalent | PHOTO MEDEX, INC. |
| K003885 | VISULAS YAG II | Feb 22, 2001 | Substantially Equivalent | CARL ZEISS, INC. |
| K003541 | DENLASER, MODEL 800 | Jan 25, 2001 | Substantially Equivalent | CAO GROUP, INC. |
| K003460 | PALOMAR CLEAR LIGHT ND: YAG LASER SYSTEM | Jan 25, 2001 | Substantially Equivalent | PALOMAR MEDICAL TECHNOLOGIES, INC. |
| K003385 | TWILITE, TWILITE WHITE | Jan 25, 2001 | Substantially Equivalent | BIOLASE TECHNOLOGY, INC. |
| K003202 | FAMILY OF ALTUS MEDICAL COOLGLIDE AESTHETIC LASERS, MODELS I & II | Jan 10, 2001 | Substantially Equivalent | ALTUS MEDICAL |
| K003151 | MICROPOBE SERIES OF LASERS AND ACCESSORIES | Jan 08, 2001 | Substantially Equivalent | ENDO OPTIKS, INC. |
| K003781 | COOLTOUCH VARIA-II ND:YAG LASER SYSTEM | Dec 20, 2000 | Substantially Equivalent | COOLTOUCH CORP. |
| K002308 | OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HOLMIUM LASER SYSTEM, MODEL 1210-VHP AND 1500-A | Dec 20, 2000 | Substantially Equivalent | TRIMEDYNE, INC. |
| K003147 | LYRA SERIES SURGICAL LASER SYSTEM (SL SERIES, ND:YAG CONFIGURATION) | Dec 15, 2000 | Substantially Equivalent | LASERSCOPE |
| K002899 | OPUS 20, MODEL 1ST | Dec 12, 2000 | Substantially Equivalent | OPUSDENT LTD. |
| K002884 | PARADIGM-FOTONA YAPLASE ND:YAP LASER SYSTEM AND ACCESSORIES | Dec 04, 2000 | Substantially Equivalent | FOTONA D.D. |
| K002853 | SCITON IMAGE HAIR REMOVAL LASER | Dec 04, 2000 | Substantially Equivalent | SCITON, INC. |
| K001211 | MODIFICATION TO INTRALASE 600C LASER KERATOME | Dec 04, 2000 | Substantially Equivalent | INTRALASE CORP. |
| K003046 | IMAGE VASCULAR LASER | Nov 24, 2000 | Substantially Equivalent | SCITON, INC. |
| K002649 | ARAMIS DERMATOLOGICAL LASER | Nov 21, 2000 | Substantially Equivalent | PALOMAR MEDICAL TECHNOLOGIES, INC. |
| K000023 | FRIENDLY LIGHT ER:YAG PULSED LASER | Nov 06, 2000 | Substantially Equivalent | INNOTECH USA, INC. |
| K002421 | CANDELA MID IR DIODE LASER SYSTEM | Nov 03, 2000 | Substantially Equivalent | CANDELA CORP. |
| K001676 | OMNIPULSE HOLMIUM LASER SYSTEM, OMNIPULSE-MAX HOLMIUM LASER SYSTEM, MODEL 1210, 1210-VHP, 1500-A | Nov 02, 2000 | Substantially Equivalent | TRIMEDYNE, INC. |
| K000317 | SPECTRA-VRM Q-SWITCHED ND:YAG LASER SYSTEM, SPECTRA-VRM | Oct 27, 2000 | Substantially Equivalent | TISSUE MEDICAL LASERS, INC. |
| K001990 | DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES | Oct 23, 2000 | Substantially Equivalent | DEPILASE GROUP LTD. |
| K000929 | PROLITE PULSED LIGHT SYSTEM | Oct 17, 2000 | Substantially Equivalent | MEDICAL BIO CARE SWEDEN AB |
| K002228 | PHOTON MODULAR WORKSTATION SYSTEM, MODELS Z-12834-X & Z-13175-X | Oct 06, 2000 | Substantially Equivalent | PARADIGM MEDICAL INDUSTRIES, INC. |
| K002296 | CERALAS G15 532NM FREQUENCY DOUBLED ND:YAG LASER, MODEL G1-G15 | Oct 02, 2000 | Substantially Equivalent | CERAMOPTEC, INC. |
| K001093 | CANDELA SPTL-1B PULSED DYE LASER | Sep 19, 2000 | Substantially Equivalent | CANDELA CORP. |
| K000727 | BUFFLIGHT CLT SURGICAL LASER SYSTEM | Sep 19, 2000 | Substantially Equivalent | Y-BEAM TECHNOLOGIES, INC. |
| K002072 | PROLITE VL PULSED LIGHT SYSTEM | Sep 11, 2000 | Substantially Equivalent | MEDICAL BIO CARE SWEDEN AB |
| K002032 | C02 LASER MULTIPULSE | Sep 11, 2000 | Substantially Equivalent | ASCLEPION-MEDITEC AG |
| K001784 | VIRIDIS LASER | Sep 11, 2000 | Substantially Equivalent | COSMOS MEDICAL TECHNOLOGY |
| K001704 | ATHOS | Aug 31, 2000 | Substantially Equivalent | COSMOS MEDICAL TECHNOLOGY |
| K000811 | NLITE SYSTEM, SLS MODEL NUMBER A00-1025 | Aug 25, 2000 | Substantially Equivalent | SLS BIOPHILE LTD. |
| K000158 | VEINLASE, MODEL E50-K8-B5, SPECTRUM K8, MODEL E50-K8-B9 | Aug 24, 2000 | Substantially Equivalent | FISMA, INC. |
| K001589 | CANDELA DYNAMIC COOLING DEVICE | Aug 18, 2000 | Substantially Equivalent | CANDELA CORP. |
| K002347 | COOLTOUCH II | Aug 17, 2000 | Substantially Equivalent | NEW STAR LASERS, INC. |
| K001975 | CERALAS D10 810NM LASER, MODEL CERALAS D10-60 | Aug 04, 2000 | Substantially Equivalent | CERAMOPTEC, INC. |
| K990119 | EPI-STAR SURGICAL LASER SYSTER | Jul 27, 2000 | Substantially Equivalent | NIDEK, INC. |
| K001527 | FOTONA FIDELIS ER: YAG LASER SYSTEM AND ACCESORIES | Jul 27, 2000 | Substantially Equivalent | FOTONA D.D. |
| K001746 | LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM (FAMILY OF PRODUCTS) | Jul 19, 2000 | Substantially Equivalent | COHERENT STAR |
| K001511 | O-LAS OPHTHALMIC PHOTODISRUPTOR | Jul 19, 2000 | Substantially Equivalent | A.R.C. LASER AG |
| K993328 | SURGILIGHT, INC EXCIMER LASER | Jul 18, 2000 | Substantially Equivalent | SURGILIGHT, INC. |
| K001322 | PERFORMER 30 HPS | Jun 30, 2000 | Substantially Equivalent | CORNELIA DAMSKY, INC. |
| K993154 | LASER PHOTOLYSIS SYSTEM, PHARO OPHTHALMIC SURGERY SYSTEM | Jun 29, 2000 | Substantially Equivalent | A.R.C. LASER CORP. |
| K992757 | CYNOSURE APOGEE-TKS DERMATOLOGICAL LASER | Jun 29, 2000 | Substantially Equivalent | CYNOSURE, INC. |
| K001031 | URANUS, COMFORTOUCH LASER SYSTEM | Jun 29, 2000 | Substantially Equivalent | LASER MAX MEDICAL TECHNOLOGIES CORP. |
| K000990 | OPUS 10 DENTAL DIODE LASER | Jun 23, 2000 | Substantially Equivalent | OPUSDENT LTD. |
| K000072 | DORNIER MEDILAS D SKINPULSE | Jun 12, 2000 | Substantially Equivalent | DORNIER SURGICAL PRODUCTS, INC. |
| K994116 | LASER SYSTEM MEDIOSTAR H (WITH AND WITHOUT SKIN COOLING SYSTEM) | Jun 01, 2000 | Substantially Equivalent | AESCULAP-MEDITEC NORTH AMERICA |
| K994260 | CANDELA GENTLELASE GL DERMATOLOGICAL LASER | May 26, 2000 | Substantially Equivalent | CANDELA CORP. |
| K001243 | DORNIER MEDILAS H | May 24, 2000 | Substantially Equivalent | DORNIER SURGICAL PRODUCTS, INC. |
| K994225 | PALOMAR SLP 2000 | May 18, 2000 | Substantially Equivalent | PALOMAR MEDICAL TECHNOLOGIES, INC. |
| K000693 | UMECO OPTIMA MULTILINE LASER SYSTEM | May 16, 2000 | Substantially Equivalent | MEDICAL LASER SOLUTIONS LLC. |
| K000503 | MEDART 520 COOLING SYSTEM | May 15, 2000 | Substantially Equivalent | MEDART CORP. |
| K993815 | UNI-LASER 430 | May 11, 2000 | Substantially Equivalent | MEDART CORP. |
| K001263 | SHARPLAN LASERS, INC. PULSED CTH:YAG HOLMIUM SURGICAL LASER, MODEL 2040 | May 05, 2000 | Substantially Equivalent | E S C SHARPLAN |
| K000805 | KAVO K.E.Y. LASER 1242 | May 04, 2000 | Substantially Equivalent | KAVO AMERICA |
| K000982 | A100 AESTHETIC DIODE LASER | May 01, 2000 | Substantially Equivalent | DIOMED, INC. |
| K992597 | LORAD LT-100 LASER TREATMENT SYSTEM | Apr 24, 2000 | Substantially Equivalent | FOCUS MEDICAL, LLC. |
| K000222 | UM-L25 | Apr 19, 2000 | Substantially Equivalent | UNION MEDICAL ENGENEERING CO., LTD. |
| K000106 | DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES | Apr 18, 2000 | Substantially Equivalent | FOTONA D.D. |
| K000192 | E3 MICROPROB SERIES OF LASERS AND ACCESSORIES | Apr 10, 2000 | Substantially Equivalent | MARTIN URAM, MD |
| K000498 | COHERENT LASERLINK Z-1000 SLIT LAMP LASER DELIVERY ADAPTER | Mar 13, 2000 | Substantially Equivalent | LUMENIS, INC. |
| K000490 | CYNOSURE PHOTOGENICA VLS-STAR | Mar 13, 2000 | Substantially Equivalent | CYNOSURE, INC. |
| K990718 | ORION SERIES SURGICAL LASER SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION) | Mar 08, 2000 | Substantially Equivalent | LASERSCOPE |
| K991798 | ACME MEDICAL AESTHETIC ND:YAG LASER | Mar 06, 2000 | Substantially Equivalent | ALTUS MEDICAL |
| K994014 | ESC INTENSE PULSED LIGHT SYSTEMS: EPILIGHT AND MULTILIGHT | Feb 24, 2000 | Substantially Equivalent | ESC MEDICAL SYSTEMS LTD. |
| K993834 | SURGICAL LIGHTSTIC, MODELS, 180 L, AND 180 C | Feb 04, 2000 | Substantially Equivalent | CARDIOFOCUS, INC. |
| K993911 | CERALAS D DIODE LASER SYSTEM, MODEL D15, D25,D50 | Feb 01, 2000 | Substantially Equivalent | CERAMOPTEC, INC. |
| K993828 | CERALAS D10 810NM DIODE LASER | Feb 01, 2000 | Substantially Equivalent | CERAMOPTEC, INC. |
| K992914 | EXCIMER LASER PHOTOTHERAPY SYSTEM, AL7000 | Jan 27, 2000 | Substantially Equivalent | ACCULASE, INC. |
| K991935 | EPILIGHT HAIR REMOVAL SYSTEM, PHOTODERM HR SYSTEM | Jan 27, 2000 | Substantially Equivalent | ESC MEDICAL SYSTEMS LTD. |
| K993671 | CANDELA SCLERO LONG PULSE DYE LASER | Jan 24, 2000 | Substantially Equivalent | CANDELA CORP. |
| K994273 | MODEL 1000 HOLMIUM LASER SYSTEM | Jan 20, 2000 | Substantially Equivalent | NEW STAR LASERS, INC. |
| K994437 | CYNOSURE PHOTOGENICA SPIR | Jan 18, 2000 | Substantially Equivalent | CYNOSURE, INC. |
| K994427 | CYNOSURE M2 DERMATOLOGY LASER FOR HAIR REMOVAL | Jan 18, 2000 | Substantially Equivalent | CYNOSURE, INC. |
| K993942 | LITESABER 2000 | Jan 18, 2000 | Substantially Equivalent | LASER DENTAL INNOVATIONS |
| K992482 | DELIGHT II HAIR REMOVAL SYSTEM (THE DELIGHT SYSTEM) | Dec 27, 1999 | Substantially Equivalent | RADIANCY, LTD. |
| K993209 | SOFTLIGHT Q-SWITCHED ND: YAG LASER WITH OPTIONAL BEAM-SHRINKING HANDPIECE ACCESSORY | Dec 23, 1999 | Substantially Equivalent | THERMOLASE CORP. |
| K994010 | INNOVAQUARTZ GENERAL SHAPE LASER FIBER | Dec 17, 1999 | Substantially Equivalent | INNOVAQUARTZ |
| K993153 | INTRALASE 600C LASER KERATOME | Dec 17, 1999 | Substantially Equivalent | INTRALASE CORP. |
| K992298 | IRIDERM, MODEL APEX 800 | Dec 09, 1999 | Substantially Equivalent | IRIDEX CORP. |
| K993285 | AURORA SL | Nov 18, 1999 | Substantially Equivalent | PREMIER LASER SYSTEMS, INC. |
| K992866 | OPTILITE IX LASER SURGERY ACCESSORIES | Nov 18, 1999 | Substantially Equivalent | CONVERGENT LASER TECHNOLOGIES |
| K992824 | LASEREX ND:YAG OPHTHALMIC LASER (LQ2106), ALCON ND:YAG OPHTHALMIC LASER (3000LE), LASEREX ND:YAG OPHTHALMIC LASER, MODEL | Nov 17, 1999 | Substantially Equivalent | Ellex Medical Pty. Ltd. |
| K991993 | PHACOLASE ER: YAG LASER | Nov 17, 1999 | Substantially Equivalent | AESCULAP-MEDITEC GMBH |
| K993146 | DORNIER SCANNER HANDPIECE | Nov 08, 1999 | Substantially Equivalent | DORNIER SURGICAL PRODUCTS, INC. |
| K992574 | OMNIPULSE HOLMIUM LASER SYSTEM MODEL 1210, OMNIPULSE-MAX HOLMIUM LASER SYSTEM MODELS 1210-VHP, 1500A | Oct 29, 1999 | Substantially Equivalent | TRIMEDYNE, INC. |
| K992707 | MCL 29 DERMABLATE ER:YAG LASER SYSTEM | Oct 19, 1999 | Substantially Equivalent | AESCULAP-MEDITEC NORTH AMERICA |
| K993002 | CERALAS D 980NM DIODE LASER SYSTEM, MODEL D15 | Oct 14, 1999 | Substantially Equivalent | CERAMOPTEC, INC. |
| K992536 | TECHNOSANAT KRYO TSK 2005 | Oct 08, 1999 | Substantially Equivalent | TECHNOSANAT INNOVATIVE MEDIZINTECHNIK GMBH |
| K992374 | AURORA HL | Sep 22, 1999 | Substantially Equivalent | PREMIER LASER SYSTEMS, INC. |
| K992814 | CYNOSURE ACCOLADE LASER | Sep 15, 1999 | Substantially Equivalent | CYNOSURE, INC. |
| K992630 | THERMALIGHT 2000 | Sep 10, 1999 | Substantially Equivalent | JENNIFERMAXX, INC. |
| K991994 | TWILIGHT | Sep 10, 1999 | Substantially Equivalent | BIOLASE TECHNOLOGY, INC. |
| K992765 | CYNOSURE DIODERM | Sep 08, 1999 | Substantially Equivalent | CYNOSURE, INC. |
| K992472 | SUREGUIDE CO2 LASER BEAM DELIVERY SYSTEM | Sep 08, 1999 | Substantially Equivalent | CLINICON CORP. |
| K992013 | DEL2940 DENTAL ERBIUM LASER, DELITE DENTAL ERBIUM LASER | Sep 08, 1999 | Substantially Equivalent | CONTINUUM BIOMEDICAL, INC. |
| K992773 | CERALAS D10 810NM DIODE LASER | Sep 01, 1999 | Substantially Equivalent | CERAMOPTEC, INC. |
| K990903 | LYRA SERIES SURGICAL SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION) | Aug 27, 1999 | Substantially Equivalent | LASERSCOPE |
| K992620 | BLULAZE | Aug 20, 1999 | Substantially Equivalent | PREMIER LASER SYSTEMS, INC. |
| K992508 | TSX PROBE, OCULAR CONTACT PROBE;TSX PROBE,OCULAR CONTACT PROBE,SMA | Aug 19, 1999 | Substantially Equivalent | INSTRUMENTS FOR MEDICINE AND DIAGNOSTICS |
| K982860 | UM-L20/ UM-L30 | Aug 13, 1999 | Substantially Equivalent | UNION MEDICAL ENGENEERING CO., LTD. |
| K991634 | FOTONA NOVALIS R RUBY LASER SYSTEM | Aug 10, 1999 | Substantially Equivalent | FOTONA D.D. |
| K991632 | FOTONA NOVALIS ER: YAG LASER SYSTEM | Aug 10, 1999 | Substantially Equivalent | FOTONA D.D. |
| K991628 | MODIFIED LX-20 CO2 LASER SYSTEM FAMILY, LX-20SA | Aug 09, 1999 | Substantially Equivalent | ESC MEDICAL SYSTEMS, INC. |
| K992061 | PULSTAR | Jul 30, 1999 | Substantially Equivalent | LASERMED, INC. |
| K990914 | POLARIS DIODE LASER SYSTEM AND ACCESSORIES | Jul 30, 1999 | Substantially Equivalent | XINTEC CORPORATION |
| K990680 | DENTEC LD 15 DIODE LASER | Jul 30, 1999 | Substantially Equivalent | DENTEK LASERSYSTEMS PRODUKTIONS GES.M.B.H. |
| K991659 | UNI-LASER 425P DIODE LASER SYSTEM & ACCESSORIES | Jul 29, 1999 | Substantially Equivalent | MEDART CORP. |
| K991464 | DENTAL 200, DENTAL 300, DENTAL 400, MODELS E-20, E-60, E-50 | Jul 20, 1999 | Substantially Equivalent | FISMA, INC. |
| K992230 | OMNITIP SIDE FIRING SWITCHABLE TIP WITH SUCTION/IRRIGATION, MODEL 20371-HP | Jul 12, 1999 | Substantially Equivalent | TRIMEDYNE, INC. |
| K992084 | CYNOSURE SURESCAN WITH THE CO3 ER: YAG LASER | Jul 12, 1999 | Substantially Equivalent | CYNOSURE, INC. |
| K992083 | SCATTERFREE LATERAL EMITTING FIBER | Jul 12, 1999 | Substantially Equivalent | LASER PERIPHERALS LLC. |
| K991297 | UNI-LASER 450P CO2 LASER SYSTEM & ACCESSORIES | Jul 12, 1999 | Substantially Equivalent | MEDART CORP. |
| K991285 | LASER SYSTEM RUBYSTAR WITH Q-SWITCH AND NORMAL MODE | Jul 12, 1999 | Substantially Equivalent | AESCULAP-MEDITEC NORTH AMERICA |
| K991234 | THE ACME MEDICAL AESTHETIC ND:YAG LASER | Jun 28, 1999 | Substantially Equivalent | ACME MEDICAL, INC. |
| K991891 | CERALAS DIODE LASER SYSTEM, MODEL CERALAS D15 | Jun 24, 1999 | Substantially Equivalent | CERAMOPTEC, INC. |
| K991183 | DORNIER LASERTRODE FIBER | Jun 09, 1999 | Substantially Equivalent | DORNIER SURGICAL PRODUCTS, INC. |
| K990243 | FOTONA FIDELIS ER:YAG LASER SYSTEM & ACCESSORIES | Jun 09, 1999 | Substantially Equivalent | FOTONA D.D. |
| K983984 | COOLTOUCH V ND:YAG | Jun 07, 1999 | Substantially Equivalent | LASER AESTHETICS, INC. |
| K990902 | MODIFICATION OF MLT R694 RUBY LASER SYSTEM | May 27, 1999 | Substantially Equivalent | MEDICAL LASER TECHNOLOGIES LTD. |
| K990568 | SCRAMBLED ENDOOTO LASER PROBE, STRAIGHT TIP, MODEL 59.02, SCRAMBLED ENDOOTO LASER PROBE BENT TIP, MODEL 59.01 | May 14, 1999 | Substantially Equivalent | SYNERGETICS, INC. |
| K991258 | NOVUS VERDI DELIVERY SYSTEMS | May 13, 1999 | Substantially Equivalent | LUMENIS, INC. |
| K984486 | PULSEMASTER DENTAL LASER SYSTEM | May 13, 1999 | Substantially Equivalent | AMERICAN DENTAL TECHNOLOGIES, INC. |
| K990748 | EDGE SYSTEMS STERILE TUBING | May 04, 1999 | Substantially Equivalent | EDGE SYSTEMS CORP. |
| K990452 | ORLIGHT 2000 SURGICAL LASER SYSTEM | Apr 29, 1999 | Substantially Equivalent | YBEAM TECHNOLOGIES, INC. |
| K990947 | MODIFIED VERSAPULSE SELECT SINGLE WAVELENGTH, HO: YAG AND DUAL WAVELENGTH, HO: YAG/ND: YAG SURGICAL LASERS AND DELIVERY | Apr 27, 1999 | Substantially Equivalent | LUMENIS, INC. |
| K990417 | DERMACOOL | Apr 14, 1999 | Substantially Equivalent | OPTOMED CORP. |
| K982940 | LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM | Apr 08, 1999 | Substantially Equivalent | STAR MEDICAL TECHNOLOGIES, INC. |
| K990174 | ATLAS-ELITE,MODEL E-80,CORIUM 200,CORIUM 400, MODEL E-90, ELITE, MODEL E-80-II, ELITE ULTRA, MODEL E-80-IV | Apr 01, 1999 | Substantially Equivalent | FISMA, INC. |
| K983524 | LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS PEIOLASE FOR LASERENAP) | Apr 01, 1999 | Substantially Equivalent | LARES RESEARCH, INC. |
| K990851 | INDIGO LASEROPTIC TREATMENT SYSTEM | Mar 30, 1999 | Substantially Equivalent | INDIGO MEDICAL, INC. |
| K984591 | DORNIER MEDILAS H/2 | Mar 26, 1999 | Substantially Equivalent | DORNIER SURGICAL PRODUCTS, INC. |
| K990780 | NUVOLASE 532 CUTANEOUS LASER SYSTEM | Mar 22, 1999 | Substantially Equivalent | AMERICAN LASER MEDICAL |
| K990725 | NUVOLASE 532 LASER SYSTEM | Mar 22, 1999 | Substantially Equivalent | AMERICAN LASER CORP. |
| K980840 | LOKKI DT | Mar 15, 1999 | Substantially Equivalent | HILLARD W. WELCH |
| K984424 | AURA DYE LASER SYSTEM (ADLS) | Mar 05, 1999 | Substantially Equivalent | LASERSCOPE |
| K982980 | LIGHTSHEER LONG PULSE RUBY LASER | Mar 04, 1999 | Substantially Equivalent | PALOMAR MEDICAL PRODUCTS, INC. |
| K990014 | DIOSCAN | Feb 26, 1999 | Substantially Equivalent | DIOMED, INC. |
| K984339 | MEDART 455 SCANNER SYSTEM | Feb 18, 1999 | Substantially Equivalent | DEL MAR TECHNOLOGIES, INC. |
| K990043 | SMOOTHLASE ALEXANDRITE LASER SYSTEM | Feb 11, 1999 | Substantially Equivalent | LEISEGANG MEDICAL, INC. |
| K983054 | MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND: YAG LASER | Feb 10, 1999 | Substantially Equivalent | CONTINUUM BIOMEDICAL, INC. |
| K984601 | CANDELA GENTLELASE II DERMATOLOGICAL LASER | Feb 04, 1999 | Substantially Equivalent | CANDELA CORP. |
| K984349 | DORNIER MEDILAS R | Feb 04, 1999 | Substantially Equivalent | DORNIER |
| K982119 | DIODE LASER | Feb 04, 1999 | Substantially Equivalent | ESC MEDICAL SYSTEMS LTD. |
| K983950 | CERALAS DIODE LASER SYSTEM (MODEL H) | Feb 03, 1999 | Substantially Equivalent | CERAMOPTEC, INC. |
| K983868 | OPMI TWINER SURGICAL MICROSCOPE | Jan 29, 1999 | Substantially Equivalent | CARL ZEISS, INC. |
| K983100 | KAVO KEY LASER 1242 | Jan 27, 1999 | Substantially Equivalent | KAVO AMERICA |
| K984517 | CYNOSURE ERASURE LASER | Jan 20, 1999 | Substantially Equivalent | CYNOSURE, INC. |
| K983673 | LASETTE | Jan 15, 1999 | Substantially Equivalent | CELL ROBOTICS, INC. |
| K983654 | CYBER-LASE 2000 CURING AND WHITENING LASER | Jan 12, 1999 | Substantially Equivalent | ICS OF NORTH AMERICA, INC. |
| K983977 | LIGHT AGE EPICARE ALEXANDRITE LASER | Jan 07, 1999 | Substantially Equivalent | LIGHT AGE, INC. |
| K983965 | CO2 LASER COUPLER | Dec 22, 1998 | Substantially Equivalent | LASER, INC. |
| K984110 | LASERSCOPE COOLSPOT | Dec 18, 1998 | Substantially Equivalent | LASERSCOPE |
| K983543 | ACCU-PULSE 1000 CO2 SURGICAL LASER SYSTEM | Dec 16, 1998 | Substantially Equivalent | ARGUS PHOTONICS GROUP |
| K982316 | LASEAWAY ALEXANDRITE LASER SYSTEM | Dec 16, 1998 | Substantially Equivalent | SILVER CREEK, INC. |
| K980475 | UNIPULSE CO2 SURGICAL LASER SYSTEM | Dec 16, 1998 | Substantially Equivalent | NIDEK, INC. |
| K983463 | SURECAUT DIAMOND LASER KNIFE | Dec 11, 1998 | Substantially Equivalent | CLINICON CORP. |
| K981746 | CELL ROBOTICS' LASETTE | Dec 07, 1998 | Substantially Equivalent | CELL ROBOTICS, INC. |
| K983215 | MULTIPULSE CO2 LASER | Dec 04, 1998 | Substantially Equivalent | AESCULAP-MEDITEC GMBH |
| K983963 | DORNIER MEDILA H | Nov 25, 1998 | Substantially Equivalent | DORNIER MEDTECH AMERICA, INC. |
| K983020 | COMPACT KTP LASER | Nov 25, 1998 | Substantially Equivalent | COSMOS MEDICAL TECHNOLOGY |
| K981379 | AURORA | Nov 23, 1998 | Substantially Equivalent | PREMIER LASER SYSTEMS, INC. |
| K983058 | CERALAS D LASER SYSTEM, MODEL # CERALAS D15 | Oct 21, 1998 | Substantially Equivalent | CERAMOPTEC, INC. |
| K982548 | MLT 30 LASER | Oct 19, 1998 | Substantially Equivalent | MEDICAL LASER TECHNOLOGIES LTD. |
| K983211 | CENTAURI | Oct 09, 1998 | Substantially Equivalent | PREMIER LASER SYSTEMS, INC. |
| K982113 | UMECO OPTIMA 694 RUBY LASER SYSTEM | Sep 30, 1998 | Substantially Equivalent | UMECO, INC. |
| K982230 | LASETTE LASER SKIN PERFORATOR | Sep 24, 1998 | Substantially Equivalent | CELL ROBOTICS, INC. |
| K980398 | KAPLAN PENDULASER 115 SURGICAL LASER WITH OPTOSCAN II | Sep 22, 1998 | Substantially Equivalent | OPTOMEDIC MEDICAL TECHNOLOGIES LTD. |
| K982827 | DERMA K ER:YAG/CO2 LASER | Sep 14, 1998 | Substantially Equivalent | ESC MEDICAL SYSTEMS, INC. |
| K982629 | DORNIER MEDILAS D | Sep 14, 1998 | Substantially Equivalent | DORNIER SURGICAL PRODUCTS, INC. |
| K981143 | DILKES LASER/SUCTION CANNULAE | Sep 14, 1998 | Substantially Equivalent | EXMOOR PLASTICS LTD. |
| K983034 | CYNOSURE CO3 ER:YAG LASER | Sep 10, 1998 | Substantially Equivalent | CYNOSURE, INC. |
| K982031 | OCULIGHT GL WITH THE DERMATOLOGY HANDPIECE | Sep 08, 1998 | Substantially Equivalent | IRIDEX CORP. |
| K981952 | COMBINATION ND:YAG AND FREQUENCY DOUBLED SOLID STATE GREEN LASER | Sep 01, 1998 | Substantially Equivalent | INSTRUMENTS FOR MEDICINE AND DIAGNOSTICS |
| K980559 | PEGASUS ND:YAG LASER SYSTEM | Aug 24, 1998 | Substantially Equivalent | PREMIER LASER SYSTEMS, INC. |
| K982295 | NIDEK LIGHTSCAN | Aug 06, 1998 | Substantially Equivalent | NIDEK, INC. |
| K981627 | PROTEGE II ER: YAG LASER SYSTEM AND ACCESSOIES (UPGRADE) | Jul 31, 1998 | Substantially Equivalent | XINTEC CORPORATION |
| K980389 | MEGABEAM REUSABLE FIBER OPTIC HANDPIECE AND NEEDLES | Jul 29, 1998 | Substantially Equivalent | CERAMOPTEC, INC. |
| K980517 | EPILASER NORMAL MODE RUBY LASER | Jul 21, 1998 | Substantially Equivalent | PALOMAR MEDICAL PRODUCTS, INC. |
| K981438 | DORNIER MEDILAS E | Jul 20, 1998 | Substantially Equivalent | DORNIER SURGICAL PRODUCTS, INC. |
| K981718 | DORNIER MEDILAS H | Jul 17, 1998 | Substantially Equivalent | DORNIER SURGICAL PRODUCTS, INC. |
| K972575 | 800 SERIES SURGICAL LASER SYSTEM ORION SERIES SURGICAL LASER SYSTEM ANGLED DELIVERY DEVICES | Jul 17, 1998 | Substantially Equivalent | LASERSCOPE |
| K970069 | DUAL HOOK FIBEROPTIC DELIVERY SYSTEM | Jul 17, 1998 | Substantially Equivalent | IHD, INC. |
| K974586 | AURORA DIODE LASER SYSTEM | Jul 15, 1998 | Substantially Equivalent | PREMIER LASER SYSTEMS, INC. |
| K981351 | CANDELA GENTLELASE GL DERMATOLOGICAL LASER | Jul 13, 1998 | Substantially Equivalent | CANDELA CORP. |
| K981350 | ALEXIS ALEXANDRITE LASER SYSTEM AND ACCESSORIES | Jul 09, 1998 | Substantially Equivalent | XINTEC CORPORATION |
| K980538 | LASER LANCET LB100 | Jul 09, 1998 | Substantially Equivalent | TRANSMEDICA INTL., INC. |
| K980501 | SKINTONER SYSTEM | Jul 08, 1998 | Substantially Equivalent | FULLER RESEARCH CORP. |
| K981149 | LASETTE LASER SKIN PERFORATOR | Jun 29, 1998 | Substantially Equivalent | CELL ROBOTICS, INC. |
| K980753 | CHROMOSCAN SCANNING SYSTEM | Jun 29, 1998 | Substantially Equivalent | MEHL/BIOPHILE INTL., INC. |
| K981126 | CERALAS G FREQUENCY DOUBLED ND: YAG LASER SYSTEMS, CERALAS G3 | Jun 25, 1998 | Substantially Equivalent | CERAMOPTEC, INC. |
| K974641 | FUTURELASE 3000/3002 ERBIUM LASER SYSTEM | Jun 08, 1998 | Substantially Equivalent | BUCKMAN CO., INC. |
| K981447 | DIO-LIGHT 60 LASER SYSTEM | Jun 05, 1998 | Substantially Equivalent | NIDEK, INC. |
| K980838 | REUSABLE MEGABEAM FIBER OPTIC DELIVERY SYSTEM | Jun 02, 1998 | Substantially Equivalent | CERAMOPTEC, INC. |
| K980710 | SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 755 DP ALEXANDRITE LASER SYSTEM | May 22, 1998 | Substantially Equivalent | SCHWARTZ ELECTRO-OPTICS, INC. |
| K980685 | MODIFIED VERSAPULSE SELECT HO:YAG AND HO:YAG/ND:YAG LASERS | May 20, 1998 | Substantially Equivalent | LUMENIS, INC. |
| K974536 | PHOTODERM HR SYSTEM | May 20, 1998 | Substantially Equivalent | ESC MEDICAL SYSTEMS LTD. |
| K980547 | NIDEK PRIMA MODEL GYC-1500/2000 | May 13, 1998 | Substantially Equivalent | NIDEK, INC. |
| K971207 | SOFTLIGHT Q-SWITCHED (ND:YAG) LASER | May 13, 1998 | Substantially Equivalent | THERMOLASE CORP. |
| K980420 | LIGHTSHEER | May 04, 1998 | Substantially Equivalent | PALOMAR MEDICAL PRODUCTS, INC. |
| K980784 | SURETOUCH | Apr 29, 1998 | Substantially Equivalent | SAHAR TECHNOLOGIES, INC. |
| K974674 | CYNOSURE PHOTOLIGHT FLASHLAMP SYSTEM | Apr 29, 1998 | Substantially Equivalent | CYNOSURE, INC. |
| K981090 | LASERLITE DIODE SURGICAL LASER | Apr 21, 1998 | Substantially Equivalent | LASERLITE, LLC. |
| K980361 | DERMABLATE ER: YAG LASER SYSTEM | Apr 21, 1998 | Substantially Equivalent | AESCULAP-MEDITEC NORTH AMERICA |
| K974057 | DENTEK LD 15 LASERSYSTEM | Apr 21, 1998 | Substantially Equivalent | DENTEK LASERSYSTEMS PRODUKTIONS GES.M.B.H. |
| K972548 | SLT CL MD CONTACT LASER SYSTEM | Apr 21, 1998 | Substantially Equivalent | SURGICAL LASER TECHNOLOGIES, INC. |
| K980537 | ND: YAG ACCESSORY FOR PHOTODERM SYSTEM | Apr 15, 1998 | Substantially Equivalent | ESC MEDICAL SYSTEMS LTD. |
| K980187 | MLT R694 RUBY LASER SYSTEM | Apr 03, 1998 | Substantially Equivalent | MEDICAL LASER TECHNOLOGIES LTD. |
| K980142 | FEATHERLITE DIODE LASER | Apr 03, 1998 | Substantially Equivalent | LASERLITE, LLC. |
| K980560 | FOTONA SKINPLUS LASER SYSTEM | Mar 27, 1998 | Substantially Equivalent | FOTONA D.D. |
| K974896 | LASERSCOPE EL LASER SYSTEM AND ACCESSORIES | Mar 27, 1998 | Substantially Equivalent | LASERSCOPE |
| K974878 | E3 MICROPROBE | Mar 27, 1998 | Substantially Equivalent | MARTIN URAM, MD |
| K980561 | DERMIUM | Mar 19, 1998 | Substantially Equivalent | PREMIER LASER SYSTEMS, INC. |
| K980313 | SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASE | Mar 19, 1998 | Substantially Equivalent | SCHWARTZ ELECTRO-OPTICS, INC. |
| K980001 | JENASCAN | Mar 19, 1998 | Substantially Equivalent | JENOPTIK LASER, OPTIK, SYSTEME GMBH |
| K974732 | NIDEK MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-7000 | Mar 18, 1998 | Substantially Equivalent | NIDEK, INC. |
| K980201 | DIO-LIGHT LASER SYSTEM | Mar 16, 1998 | Substantially Equivalent | NIDEK, INC. |
| K980160 | EPILASER I UPGRADE KIT | Mar 10, 1998 | Substantially Equivalent | PALOMAR MEDICAL PRODUCTS, INC. |
| K974789 | COHERENT ULTRAPULSE S SERIES CO2 SURGICAL LASERS MODEL C AND L | Mar 09, 1998 | Substantially Equivalent | LUMENIS, INC. |
| K980156 | SLT SELECT FIBER DELIVERY SYSTEM AND CONTACT TIPS | Feb 27, 1998 | Substantially Equivalent | SURGICAL LASER TECHNOLOGIES, INC. |
| K974900 | CYNOSURE PHOTOGENICA 532 LASER | Feb 27, 1998 | Substantially Equivalent | CYNOSURE, INC. |
| K980131 | ALEX TA2 ERASER | Feb 17, 1998 | Substantially Equivalent | LIGHT AGE, INC. |
| K974381 | CANDELA GENTLELASE GL DERMATOLOGICAL LASER | Feb 10, 1998 | Substantially Equivalent | CANDELA CORP. |
| K974229 | LS-905 FIBERCHOICE ADAPTER SYSTEM | Feb 10, 1998 | Substantially Equivalent | LASER PERIPHERALS LLC. |
| K973867 | SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 755 LASER SYSTEM | Feb 10, 1998 | Substantially Equivalent | SCHWARTZ ELECTRO-OPTICS, INC. |
| K973172 | RESPOSABLE BARE FIBERS | Feb 03, 1998 | Substantially Equivalent | TRIMEDYNE, INC. |
| K974142 | HM-RUBY | Jan 28, 1998 | Substantially Equivalent | AMERICAN LASERS, INC. |
| K974633 | SCANTECH LASER SCANNER | Jan 16, 1998 | Substantially Equivalent | PHANTOM TECHNOLOGIES, INC. |
| K974460 | LITE TOUCH ERBIUM LASER TREATMENT SYSTEM | Jan 16, 1998 | Substantially Equivalent | LORAD CORP. |
| K974346 | STARLIGHT PULSED DIODE ARRAY LASER SYSTEM | Jan 16, 1998 | Substantially Equivalent | STAR MEDICAL TECHNOLOGIES, INC. |
| K974039 | SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASE | Jan 12, 1998 | Substantially Equivalent | SCHWARTZ ELECTRO-OPTICS, INC. |
| K973828 | PRIMA KTP LASER SYSTEM | Jan 05, 1998 | Substantially Equivalent | NIDEK, INC. |
| K973764 | TEMPERATURE DIAGNOSTIC ACCESSORY | Dec 31, 1997 | Substantially Equivalent | NEW STAR LASERS, INC. |
| K973719 | MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND:YAG LASER | Dec 23, 1997 | Substantially Equivalent | CONTINUUM BIOMEDICAL, INC. |
| K963969 | INDIGO PORTABLE LASER SYSTEM WITH TEMPERATURE FEEDBACK -MODEL IDL 830 (POWER OPTIONS : 25, 20, 15 & 10 WATTS) INDIGO FIB | Dec 23, 1997 | Substantially Equivalent | INDIGO MEDICAL, INC. |
| K973603 | SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 1064/532 LASER SYSTEM | Dec 19, 1997 | Substantially Equivalent | SCHWARTZ ELECTRO-OPTICS, INC. |
| K972915 | ERBIUM 2000 LASER FAMILY | Dec 19, 1997 | Substantially Equivalent | PHANTOM TECHNOLOGIES, INC. |
| K971118 | ARAGO | Dec 16, 1997 | Substantially Equivalent | PREMIER LASER SYSTEMS, INC. |
| K973576 | EPULSE MODEL 2940 ER:ASER ER:YAG LASER SYSTEM | Dec 09, 1997 | Substantially Equivalent | EPULSE TECHNOLOGIES, INC. |
| K973470 | COHERENT POPEYE OPHTHALMIC LASER SYSTEM, COHERENT POPEYE OPHTHALMIC LASER SYSTEM IN COMBINATION WITH THE COHERENT ARGONS | Dec 09, 1997 | Substantially Equivalent | LUMENIS, INC. |
| K973354 | SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000) | Dec 04, 1997 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K972767 | CANDELA GENTLELASE GL DERMATOLOGICAL VASCULAR LESION LASER | Dec 04, 1997 | Substantially Equivalent | CANDELA CORP. |
| K973324 | STARLIGHT PULSED DIODE ARRAY LASER SYSTEM | Dec 03, 1997 | Substantially Equivalent | STAR MEDICAL TECHNOLOGIES, INC. |
| K973498 | CYNOSURE PHOTOGENICA ER LASER | Nov 13, 1997 | Substantially Equivalent | CYNOSURE, INC. |
| K971912 | PROTEGE ER:YAG LASER SYSTEM AND ACCESSORIES | Nov 03, 1997 | Substantially Equivalent | XINTEC CORPORATION |
| K970143 | C4 | Oct 29, 1997 | Substantially Equivalent | CLINICON CORP. |
| K973431 | LASETTE | Oct 28, 1997 | Substantially Equivalent | CELL ROBOTICS, INC. |
| K972872 | DERMA K LASER SYSTEM | Oct 28, 1997 | Substantially Equivalent | ESC MEDICAL SYSTEMS LTD. |
| K972028 | DERMASCAN SURGICAL LASER SCANNER | Oct 24, 1997 | Substantially Equivalent | ESC MEDICAL SYSTEMS LTD. |
| K972765 | NUVOLASE 720 SYSTEM FOR OPHTHALMOLOGY LASER | Oct 21, 1997 | Substantially Equivalent | AMERICAN LASER MEDICAL |
| K972561 | NUVOLASE 660 LASER SYSTEM FOR OPHTHALMOLOGY | Oct 06, 1997 | Substantially Equivalent | AMERICAN LASER MEDICAL |
| K970475 | MM-RUBY | Sep 29, 1997 | Substantially Equivalent | AMERICAN LASERS, INC. |
| K971821 | UNICA 315 M CO2 SURGICAL LASER SYSTEM | Sep 25, 1997 | Substantially Equivalent | RELIANT TECHNOLOGIES, INC. |
| K972368 | FOTONA SKINLIGHT PLUS ND: YAG SYSTEM | Sep 23, 1997 | Substantially Equivalent | MEDICAL LASER SOLUTIONS |
| K972347 | MODIFIED COHERENT VERSAPULSE AESTHETIC SURGICAL LASER | Sep 19, 1997 | Substantially Equivalent | LUMENIS, INC. |
| K972325 | PULSEMASTER 1000 ST DENTAL LASER SYSTEM | Sep 19, 1997 | Substantially Equivalent | AMERICAN DENTAL TECHNOLOGIES, INC. |
| K970808 | MEDLITE IV Q-SWITCHED, FREQUENCY DOUBLED, ND:YAG LASER | Sep 05, 1997 | Substantially Equivalent | CONTINUUM BIOMEDICAL, INC. |
| K972099 | SHARPLAN EPITOUCH RUBY LASER SYSTEM | Aug 27, 1997 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K972002 | CYNOSURE DERMATOLOGY LASER COOLING TIP | Aug 27, 1997 | Substantially Equivalent | CYNOSURE, INC. |
| K971903 | SCANNING DEVICE ACCESSORY FOR USE WITH THE CB DIODE/532 ND:YAG LASER | Aug 21, 1997 | Substantially Equivalent | CONTINUUM BIOMEDICAL, INC. |
| K971874 | SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000) | Aug 18, 1997 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K971879 | SCANNING DEVICE ACCESSORY FOR USE WITH THE CB ERBIUM/2.94 ER:YAG LASER | Aug 14, 1997 | Substantially Equivalent | CONTINUUM BIOMEDICAL, INC. |
| K971830 | ACCU-PULSE CARBON DIOXIDE LASER SYSTEM | Aug 14, 1997 | Substantially Equivalent | ARGUS PHOTONICS GROUP |
| K965124 | LASETTE | Aug 14, 1997 | Substantially Equivalent | CELL ROBOTICS, INC. |
| K971737 | CYNOSURE PHOTOGENICA LPIR DERMATOLOGICAL LASER | Aug 08, 1997 | Substantially Equivalent | CYNOSURE, INC. |
| K964831 | SURESCAN | Aug 08, 1997 | Substantially Equivalent | CLINICON CORP. |
| K971814 | IMPROVEMENTS TO THE MEHL RUBY LASER | Aug 01, 1997 | Substantially Equivalent | MEHL/BIOPHILE INTL., INC. |
| K972272 | LASER PERIPHERALS HOLMIUM BARE FIBERS | Jul 29, 1997 | Substantially Equivalent | LASER PERIPHERALS LLC. |
| K971843 | LASERSCOPE VELA ERBIUM:YAG LASER SYSTEM AND ACCESSORIES | Jul 23, 1997 | Substantially Equivalent | LASERSCOPE |
| K971648 | SHARPLAN ERBIUM: YAG LASER (4020) | Jul 23, 1997 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K971743 | SHARPLAN CO2 SURGICAL LASER SYSTEM | Jul 18, 1997 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K971459 | DERMALASE | Jul 18, 1997 | Substantially Equivalent | ENDO TECHNIC CORP. |
| K965128 | CYNOSURE PHOTOGENICA VLV CUTANEOUS VASCULAR LESION LASER | Jul 14, 1997 | Substantially Equivalent | CYNOSURE, INC. |
| K970461 | CELL ROBOTICS ER: YAG SURGICAL LASER | Jul 11, 1997 | Substantially Equivalent | CELL ROBOTICS, INC. |
| K971404 | SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940/ERBIUM CRYSTALASE (FORMERLY TRILASE 2940 ERBIUM LASER | Jul 09, 1997 | Substantially Equivalent | SCHWARTZ ELECTRO-OPTICS, INC. |
| K963249 | EPILIGHT HAIR REMOVAL SYSTEM | Jul 07, 1997 | Substantially Equivalent | ESC MEDICAL SYSTEMS LTD. |
| K971250 | LASERSCOPE MICROBEAM IV MICROMANIPULATOR | Jun 30, 1997 | Substantially Equivalent | LASERSCOPE |
| K971193 | LASEAWAY LONG PULSE AND Q-SWITCHED RUBY LASER SYSTEM | Jun 24, 1997 | Substantially Equivalent | POLYTEC PI, INC. |
| K971065 | DENTICA PULSED ND: YAG LASER SYSTEMS AND ACCESSORIES | Jun 17, 1997 | Substantially Equivalent | XINTEC CORPORATION |
| K971024 | SOFTSCAN | Jun 17, 1997 | Substantially Equivalent | SAHAR TECHNOLOGIES, INC. |
| K964818 | ORION SERIES SURGICAL LASER SYSTEM (Q-SWITCHED ND:YAG CONFIGURATION) | Jun 17, 1997 | Substantially Equivalent | LASERSCOPE |
| K970934 | CB ERBIUM/2.94(TM) ER:YAG LASER | Jun 11, 1997 | Substantially Equivalent | CONTINUUM BIOMEDICAL, INC. |
| K965180 | STRAIGHTFIRE REUSABLE OPTICAL FIBERS (400,600,800,1000) | Jun 05, 1997 | Substantially Equivalent | MYRIADLASE, INC. |
| K971539 | NOVATIP FAMILY OF LASER HANDPIECE TIPS | Jun 03, 1997 | Substantially Equivalent | XANOVA CORP. |
| K970804 | TRU-PULSE CO2 SURGICAL LASER | Jun 03, 1997 | Substantially Equivalent | TISSUE TECHNOLOGIES, INC. |
| K970243 | CYNOSURE DLS-10-810 DIODE LASER GENERAL PHOTOCOAGULATOR | Jun 03, 1997 | Substantially Equivalent | CYNOSURE, INC. |
| K970948 | 800 SERIES SURGICAL LASER SYSTEM AND ACCCESSORIES | May 21, 1997 | Substantially Equivalent | LASERSCOPE |
| K970667 | NUVO-LASE 660 LASER SYSTEM | May 13, 1997 | Substantially Equivalent | AMERICAN LASER MEDICAL |
| K963340 | MEDLITE ND:YAG LASER SYSTEM: NEW DYE ACCESSORY HANDPIECE | May 12, 1997 | Substantially Equivalent | CONTINUUM BIOMEDICAL, INC. |
| K970757 | FOTONA SKINSCAN | May 09, 1997 | Substantially Equivalent | MEDICAL LASER SOLUTIONS |
| K933841 | CENTAURI | May 05, 1997 | Substantially Equivalent | PREMIER LASER SYSTEMS, INC. |
| K932683 | CENTAURI | May 05, 1997 | Substantially Equivalent | PREMIER LASER SYSTEMS, INC. |
| K963996 | (FSI) LAPAROSCOPIC PROBE FOR ALL FSI ULE FF101 FIBERS. MODEL FSI FF101-LP-XXX, WHERE XXX = FIBER DIAMETERS 100, 200, 400 | Apr 24, 1997 | Substantially Equivalent | FULL SPECTRUM, INC. |
| K963991 | FSI LAPAROSCOPIC PROBE FOR ALL FSI ULE-OVERCLAD FF201 FIBERS | Apr 24, 1997 | Substantially Equivalent | FULL SPECTRUM, INC. |
| K970422 | RIGHT ANGLE LASER FIBERS;OPTILASE ND:YAG LASER;OPTILASE PL100 ND LASER SYSTEMS | Apr 21, 1997 | Substantially Equivalent | TRIMEDYNE, INC. |
| K964585 | RESPOSABLE OMNI TIP(TM) SWITCHABLE TIPS (MULTIPLE) | Apr 17, 1997 | Substantially Equivalent | TRIMEDYNE, INC. |
| K964253 | DERMA 20 LASER SYSTEM | Apr 11, 1997 | Substantially Equivalent | ESC MEDICAL SYSTEMS LTD. |
| K955653 | VENISECT LASER LANCET | Apr 11, 1997 | Substantially Equivalent | VENISECT, INC. |
| K970157 | LASERSCOPE AUTOMATIC EYE PROTECTION FILTER | Apr 07, 1997 | Substantially Equivalent | LASERSCOPE |
| K970637 | ACCUCURE 1000 | Apr 02, 1997 | Substantially Equivalent | LASERMED, INC. |
| K964074 | DIOLITE 532 | Apr 01, 1997 | Substantially Equivalent | IRIDERM DIV. |
| K970361 | LASER EYE GOGGLES | Mar 18, 1997 | Substantially Equivalent | STEFANOVSKY & ASSOC. |
| K970017 | NIDEK CYBERSCAN | Mar 18, 1997 | Substantially Equivalent | NIDEK, INC. |
| K964128 | MCL 29 DERMABLATE ERBIUM LASER SYSTEM | Mar 17, 1997 | Substantially Equivalent | AESCULAP-MEDITEC GMBH |
| K961380 | CPC PROBE | Mar 17, 1997 | Substantially Equivalent | CARL ZEISS, INC. |
| K965015 | TOPAZ 30 SURGICAL LASER SYSTEM | Mar 14, 1997 | Substantially Equivalent | ESC MEDICAL SYSTEMS, INC. |
| K962791 | NEW STAR MODEL 130 6-WATT ND: YAG LASER SYSTEM | Mar 13, 1997 | Substantially Equivalent | NEW STAR LASERS, INC. |
| K962109 | SLS CHROMOS 694 QD RUBY LASER TO BE RENAMED MEHL QD RUBY LASER SYSTEM FOR HAIR REMOVAL | Mar 13, 1997 | Substantially Equivalent | CLASSY LADY BY MEHL OF PUERTO RICO, INC. |
| K961269 | PULSEMASTER | Mar 10, 1997 | Substantially Equivalent | AMERICAN DENTAL TECHNOLOGIES, INC. |
| K962446 | SHARPLAN RUBY LASER SYSTEM | Mar 07, 1997 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K963947 | EPILASER NORMAL MODE RUBY LASER | Mar 05, 1997 | Substantially Equivalent | SPECTRUM MEDICAL TECHNOLOGIES, INC. |
| K964353 | CYBERLASE CO2 LASER SYSTEM | Feb 28, 1997 | Substantially Equivalent | NIDEK, INC. |
| K963081 | INDIGO MEDICAL MODEL IDL 830 & MODEL IDL 830E LASER SYSTEMS FOR GENERAL GYNECOLOGICAL APPLICATIONS | Feb 21, 1997 | Substantially Equivalent | INDIGO MEDICAL, INC. |
| K964760 | DORNIER MEDILAS FIBER TOME LASER | Feb 19, 1997 | Substantially Equivalent | DORNIER MEDTECH AMERICA, INC. |
| K964486 | ACCUCURE 3000 | Feb 18, 1997 | Substantially Equivalent | LASERMED, INC. |
| K964684 | SOFTOUCH | Feb 14, 1997 | Substantially Equivalent | SAHAR TECHNOLOGIES, INC. |
| K963683 | TRU-PULSE LASER (MODIFIED) | Feb 12, 1997 | Substantially Equivalent | TISSUE TECHNOLOGIES, INC. |
| K964520 | PARASCAN SCANNING DEVICE | Feb 10, 1997 | Substantially Equivalent | LASERSCOPE |
| K964497 | CERALAS DIODE LASER SYSTEM (CERALAS D15) | Feb 06, 1997 | Substantially Equivalent | CERAMOPTEC, INC. |
| K961560 | ECLIPSE 2000 | Jan 27, 1997 | Substantially Equivalent | CARDIOGENES |
| K963339 | COHERENT ULTRAPULSE CO2 SURGICAL LASERS | Jan 22, 1997 | Substantially Equivalent | COHERENT MEDICAL GROUP |
| K962632 | OMNIPULSE/OMNIPULSE-MAX | Jan 16, 1997 | Substantially Equivalent | TRIMEDYNE, INC. |
| K962902 | FOTONA SKINLIGHT LASER SYSTEM | Jan 10, 1997 | Substantially Equivalent | MEDICAL LASER SOLUTIONS |
| K962965 | LIGHTSTIC MODEL 360 | Jan 09, 1997 | Substantially Equivalent | RARE EARTH MEDICAL, INC. |
| K964076 | LASERSCOPE ERBIUM; YAG LASER SYSTEM AND ACCESSORIES | Jan 08, 1997 | Substantially Equivalent | LASERSCOPE |
| K964031 | DCL8 ENHANCED PULSED ND:YAG LASER SYSTEM | Dec 23, 1996 | Substantially Equivalent | SLT-J LTD. |
| K963094 | CYNOSURE PHOTOGENICA LP DERMATOLOGICAL VASCULAR LESION LASER | Dec 16, 1996 | Substantially Equivalent | CYNOSURE, INC. |
| K964211 | DAVOL PLUME FILTER (5541420) | Dec 02, 1996 | Substantially Equivalent | DAVOL, INC., SUB. C.R. BARD, INC. |
| K963389 | FLEX-LASE 600 SERIES ION LASER SYSTEM | Nov 26, 1996 | Substantially Equivalent | AMERICAN LASER MEDICAL |
| K963193 | ACCU-BEAM LASER BLOCK 301513BG385/BEAM SPLITTERS 301513BG39 | Nov 13, 1996 | Substantially Equivalent | TRANSAMERICAN TECHNOLOGIES INTL. |
| K963124 | PC LASER WITH SMART PLUG (PC EDO & DENTAL 200) | Nov 08, 1996 | Substantially Equivalent | FISMA, INC. |
| K962068 | LIGHTSTIC MODEL 180 | Nov 08, 1996 | Substantially Equivalent | RARE EARTH MEDICAL, INC. |
| K963229 | SHARPLAN MODELS 20C, 30C, AND 40C CO2 LASERS | Nov 05, 1996 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K961935 | SHARPLAN LASERS, INC. SILKTOUCH CO2 FLASH SCANNER | Nov 01, 1996 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K961710 | AOC MEDICAL SYSTEM MODEL PHASE II 25 SURGICAL DIODE LASER SYSTEM | Nov 01, 1996 | Substantially Equivalent | APPLIED OPTRONICS CORP. |
| K961705 | AOC MEDICAL SYSTEM MODEL PHASE II 50 SURGICAL DIODE LASER SYSTEM | Nov 01, 1996 | Substantially Equivalent | APPLIED OPTRONICS CORP. |
| K962993 | CYNOSURE PHOTOAPPEAL CO2 SURGICAL LASERS | Oct 31, 1996 | Substantially Equivalent | CYNOSURE, INC. |
| K962948 | CERALAS G ND;YAG LASER SYSTEM (CERALAS G) | Oct 25, 1996 | Substantially Equivalent | CERAMOPTEC, INC. |
| K962592 | OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR, OR EQUIVALENT LASER SYSTEMS | Sep 23, 1996 | Substantially Equivalent | ALCON LABORATORIES |
| K962354 | DIOMED 15, 30, 60 SURGICAL DIODE LASER | Sep 11, 1996 | Substantially Equivalent | LIFESTREAM INT'L, INC. |
| K961006 | MEDLITE/755 ALEXANDRITE LASER SYSTEM | Sep 11, 1996 | Substantially Equivalent | CONTINUUM BIOMEDICAL, INC. |
| K960772 | PHOTODERM PL. | Sep 11, 1996 | Substantially Equivalent | ESC MEDICAL SYSTEMS LTD. |
| K962242 | SURESCAN | Sep 03, 1996 | Substantially Equivalent | CLINICON CORP. |
| K962974 | SHARPLAN LASERS, INC. AF ACUSPOT MICROMANIPULATOR (713) | Aug 21, 1996 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K960636 | LASERSONICS ND:YAG CYLINDRICALLY DIFFUSING STERILE DISPOSABLE FIBER | Aug 21, 1996 | Substantially Equivalent | HERAEUS SURGICAL, INC. |
| K961682 | ARGON CURING LASER | Aug 15, 1996 | Substantially Equivalent | PREMIER LASER SYSTEMS, INC. |
| K961748 | MEDLITE/ERBIUM LASER SYSTEM | Jul 26, 1996 | Substantially Equivalent | CONTINUUM BIOMEDICAL, INC. |
| K955612 | RD-1200H NORMAL MODE RUBY LASER SYSTEM | Jul 09, 1996 | Substantially Equivalent | SPECTRUM MEDICAL TECHNOLOGIES, INC. |
| K961516 | LASER PERIPHERALS INC. BARE FIBER | Jun 27, 1996 | Substantially Equivalent | LASER PERIPHERALS LLC. |
| K961279 | SHARPLAN LASERS, INC. RUBY LASER SYSTEM | Jun 18, 1996 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K955662 | CANDELA Q-SWITCHED ALEXANDRITE LASERS | Jun 14, 1996 | Substantially Equivalent | CANDELA LASER CORP. |
| K961136 | PULSEMASTER | Jun 03, 1996 | Substantially Equivalent | AMERICAN DENTAL TECHNOLOGIES, INC. |
| K960905 | SDL DIODE LASER SYSTEM | Jun 03, 1996 | Substantially Equivalent | SLT-J LTD. |
| K960086 | DCL8 ENHANCED PULSED ND:YAG LASER SYSTEM | Jun 03, 1996 | Substantially Equivalent | SLT-J LTD. |
| K961079 | LASER PERIPHERALS INC. SCATTERFREE FIBER | May 22, 1996 | Substantially Equivalent | LASER PERIPHERALS LLC. |
| K960821 | SLT FUMICH PROBE GUIDE | May 16, 1996 | Substantially Equivalent | SURGICAL LASER TECHNOLOGIES, INC. |
| K960867 | FREQUENCY DOUBLED ND:YAG PHOTOCOAGULATOR(VIRIDIS) FREQUENCY DOUBLED ND:YAG PHOTOCOAGULATOR(EVERGREEN 532) | May 14, 1996 | Substantially Equivalent | B.V. INTL. S.A. |
| K960768 | LASER FIBER DELIVERY/CLEANING CATHETER | May 14, 1996 | Substantially Equivalent | COOK UROLOGICAL, INC. |
| K960820 | SHARPLAN LASERS, INC. SILKTOUCH XJ SCANNER | May 10, 1996 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K960521 | SHARPLAN LASERS, INC. SILKTOUCH FLASH SCANNER | Apr 26, 1996 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K960475 | MODIFIED LUXAR LX-20 FAMILY CO2 LASER SYSTEM | Apr 26, 1996 | Substantially Equivalent | LUXAR CORP. |
| K960579 | CYNOSURE PHOTOGENICA VL CUTANEOUS VASCULAR LESION LASER | Apr 23, 1996 | Substantially Equivalent | CYNOSURE, INC. |
| K960413 | COHERENT SLIMLINE SINGLE LUMEN ASPIRATION NEEDLE KIT | Apr 04, 1996 | Substantially Equivalent | LUMENIS, INC. |
| K960032 | COHERENT VERSAPULSE AESTHETIC SURGICAL LASERS | Apr 01, 1996 | Substantially Equivalent | COHERENT MEDICAL GROUP |
| K954905 | CB DIODE/532 LASER SYSTEM | Mar 29, 1996 | Substantially Equivalent | CONTINUUM BIOMEDICAL, INC. |
| K951935 | PRODIGY SUPERPULSE ND:YAG SURGICAL LASER SYSTEMS & ACCESSORIES | Mar 25, 1996 | Substantially Equivalent | XINTEC CORPORATION |
| K951876 | PROTEGE ER:YAG SURGICAL LASER SYSTEM AND ACCESSORIES | Mar 25, 1996 | Substantially Equivalent | XINTEC CORPORATION |
| K954597 | RIGHT ANGLE LASER FIBERS | Mar 11, 1996 | Substantially Equivalent | TRIMEDYNE, INC. |
| K955862 | FULL SPECTRUM ULE-OVERCLAD FIBER: MODEL 201 | Mar 01, 1996 | Substantially Equivalent | FULL SPECTRUM, INC. |
| K955621 | SHARPLAN LASERS, INC SILKTOUCH 2 FLASH SCANNER | Feb 27, 1996 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K955131 | MEDLITE LASER SYSTEM | Feb 20, 1996 | Substantially Equivalent | CONTINUUM BIOMEDICAL, INC. |
| K955758 | INDIGO MEDICAL MODEL IDL 830E | Feb 16, 1996 | Substantially Equivalent | INDIGO MEDICAL, INC. |
| K953851 | CERALAS F ND:YAG LASER SYSTEM | Feb 16, 1996 | Substantially Equivalent | CERAMOPTEC, INC. |
| K955734 | LASERSONICS PARASCAN DOSIMETER DEVICE | Feb 13, 1996 | Substantially Equivalent | HERAEUS SURGICAL, INC. |
| K954727 | SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM (MODIFICATION) | Feb 05, 1996 | Substantially Equivalent | SURGICAL LASER TECHNOLOGIES, INC. |
| K953585 | SCHWARTZ ELECTRO-OPTICES, INC. TRILASE 2100/20 HOLMIUM LASER | Feb 05, 1996 | Substantially Equivalent | SCHWARTZ ELECTRO-OPTICS, INC. |
| K954934 | CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASE | Feb 02, 1996 | Substantially Equivalent | CANDELA LASER CORP. |
| K954013 | TRILASE 2940 ERBIUM LASER | Jan 31, 1996 | Substantially Equivalent | SCHWARTZ ELECTRO-OPTICS, INC. |
| K955861 | MICROQUARTZ MEDICAL TYPE B SIDE-FIRING LASER FIBER | Jan 26, 1996 | Substantially Equivalent | MICROQUARTZ MEDICAL, INC. |
| K955014 | APPLIED OPTRONICS MODEL AOC 25 SURGICAL DIODE | Jan 26, 1996 | Substantially Equivalent | APPLIED OPTRONICS CORP. |
| K955007 | APPLIED OPTRONICS MODEL AOC 5060 SURGFICAL DIODE LASER SYSTEM | Jan 26, 1996 | Substantially Equivalent | APPLIED OPTRONICS CORP. |
| K953670 | ACCUSCAN MODEL C CO2 LASER SCANNER | Jan 26, 1996 | Substantially Equivalent | RELIANT TECHNOLOGIES, INC. |
| K954195 | INDIGO PORTABLE LASER SYSTEM, INDDIGO FIBEROPTICS | Jan 25, 1996 | Substantially Equivalent | INDIGO MEDICAL, INC. |
| K954911 | OMEGA ULTRASCAN | Jan 24, 1996 | Substantially Equivalent | GYNE-TECH INSTRUMENT CORP. |
| K954904 | MICROQUARTZ MEDICAL GENERAL SHAPE LASER FIBER | Jan 22, 1996 | Substantially Equivalent | MICROQUARTZ MEDICAL, INC. |
| K952489 | 6 WATT HOLMIUM LASER SYSTEM | Jan 22, 1996 | Substantially Equivalent | NEW STAR LASERS, INC. |
| K955006 | ECLIPSE 2100 | Jan 17, 1996 | Substantially Equivalent | CARDIOGENES |
| K954834 | CERALAS G FREQUENCY DOUBLED ND;YAG LASER SYSTEM | Jan 17, 1996 | Substantially Equivalent | CERAMOPTEC, INC. |
| K951910 | ODYSSEY HO:YAG SURGICAL LASER SYSTEMS & ACCESSORIES | Dec 27, 1995 | Substantially Equivalent | XINTEC CORPORATION |
| K954931 | NEO-MED DLS-1100 | Dec 18, 1995 | Substantially Equivalent | NEO-LABORATORIES, LLC. |
| K954460 | ILT SURGICAL LASER | Dec 18, 1995 | Substantially Equivalent | ION LASER TECHNOLOGY |
| K954316 | AURORA SURGICAL DIODE LASER SYSTEM W/ACCESSORIES | Dec 15, 1995 | Substantially Equivalent | PREMIER LASER SYSTEMS, INC. |
| K953800 | MLT 20 | Nov 29, 1995 | Substantially Equivalent | MEDICAL LASER TECHNOLOGY, INC. |
| K951760 | OPTILITE VIII LASER SURGERY ACCESSORIES | Nov 29, 1995 | Substantially Equivalent | XINTEC CORPORATION |
| K950826 | AM RUBY | Nov 29, 1995 | Substantially Equivalent | AMERICAN LASERS, INC. |
| K952277 | SHARPLAN MODEL 2040 PULSED CTH:YAG SURGICAL LASER SYSTEM | Nov 16, 1995 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K953794 | SHARPLAN LASERS, INC. SURGICAL DIODE LASER | Nov 14, 1995 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K952682 | LOKKI DT | Nov 14, 1995 | Substantially Equivalent | LOKKI |
| K954544 | LASER GAS MIXTURE | Oct 30, 1995 | Substantially Equivalent | LIQUID TECHNOLOGY CORP. |
| K953917 | LASESONICS LOW POWER CO2 LASER SYSTEM | Oct 26, 1995 | Substantially Equivalent | HERAEUS SURGICAL, INC. |
| K953412 | CANDELA MODEL PLTL-1 LASER SYSTEM | Oct 24, 1995 | Substantially Equivalent | CANDELA LASER CORP. |
| K951117 | LIHTAN 532 LASER | Oct 18, 1995 | Substantially Equivalent | BUCKMAN CO., INC. |
| K952661 | SLT THERMALITE DIODE LASER SERIES, DIODE 980, 810, 940 | Oct 06, 1995 | Substantially Equivalent | SURGICAL LASER TECHNOLOGIES, INC. |
| K952047 | LMT 40 AA LASER SURGICAL SYSTEM | Oct 03, 1995 | Substantially Equivalent | LASER MAX MEDICAL TECHNOLOGIES CORP. |
| K952046 | LMT 20 AA LASER SURGICAL SYSTEM | Oct 03, 1995 | Substantially Equivalent | LASER MAX MEDICAL TECHNOLOGIES CORP. |
| K952045 | LMT 20 HH LASER SURGIVAL SYSTEM | Oct 03, 1995 | Substantially Equivalent | LASER MAX MEDICAL TECHNOLOGIES CORP. |
| K950996 | DORNIER THERMAFOCUS 360 FIBER | Oct 03, 1995 | Substantially Equivalent | DAIMLER-BENZ AEROSPACE |
| K953065 | ULTRABRIGHT (MICROQUARTZ MEDICAL SIDE-FIRING LASER FIBER) | Sep 27, 1995 | Substantially Equivalent | MICROQUARTZ MEDICAL, INC. |
| K952796 | ADVANCED LASER MULTILINE SYSTEM, ALY | Sep 18, 1995 | Substantially Equivalent | ADVANCED LASER SERVICES CORP. |
| K953494 | TAPERTIP MULTISUE HOLMIUM ARTHROSCOPIC HANDPIECE, VARIOUS ENDFIRING MODELS, WITH/OUT A STERILIZABLE INSTRUMENT TRAY | Sep 14, 1995 | Substantially Equivalent | TRIMEDYNE, INC. |
| K952755 | POWERSCULPTOR PROBES | Sep 14, 1995 | Substantially Equivalent | CARDIOGENES |
| K953933 | MED-TECH LASER GAS MIXTURE | Sep 01, 1995 | Substantially Equivalent | MEDICAL TECHNICAL GASES INC.. |
| K953174 | MICROQUATZ MEDICAL LINEAR MODULATOR ACCESSORY | Aug 28, 1995 | Substantially Equivalent | MICROQUARTZ MEDICAL, INC. |
| K953074 | MODIFIED LUXAR LX-20 FAMILY CO2 LASER SYSTEM | Aug 28, 1995 | Substantially Equivalent | LUXAR CORP. |
| K952974 | QUADRALASE (MICROQUARTZ MEDICAL ADJUSTABLE SIDE-FIRING LASER FIBER) | Aug 28, 1995 | Substantially Equivalent | MICROQUARTZ MEDICAL, INC. |
| K952554 | SCHWARTZ ELECTRO-OPTICS, INC. TRILASE LASER SYSTEM | Aug 28, 1995 | Substantially Equivalent | SCHWARTZ ELECTRO-OPTICS, INC. |
| K950825 | AM-YAG | Aug 28, 1995 | Substantially Equivalent | AMERICAN LASERS, INC. |
| K953658 | CORSSFIRE PLUS | Aug 21, 1995 | Substantially Equivalent | CARDIOGENES |
| K952216 | SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM & WCE DIFFUSER FLAT PROBE DF 2 | Aug 18, 1995 | Substantially Equivalent | SURGICAL LASER TECHNOLOGIES, INC. |
| K950684 | CYNOSURE PHOTOGENICA T10 TATTOO REMOVAL LASER | Aug 16, 1995 | Substantially Equivalent | CYNOSURE, INC. |
| K953424 | ECLIPSE 3200 | Aug 11, 1995 | Substantially Equivalent | CARDIOGENES |
| K950120 | SMART PLUG | Aug 11, 1995 | Substantially Equivalent | HGM, INC. |
| K952118 | ELMER | Aug 07, 1995 | Substantially Equivalent | BIOLOGICAL TECHNOLOGY CORP. |
| K950493 | PHOTODERM VL. | Aug 07, 1995 | Substantially Equivalent | ESC, ENERGY SYSTEMS CORP. |
| K952754 | SACS, INDEPENDENT FIBER COOLANT SYSTEM | Jul 31, 1995 | Substantially Equivalent | SURGICAL LASER TECHNOLOGIES, INC. |
| K952733 | SIDEFIRE - TIPPED REUSABLE OPTICAL FIBERS | Jul 31, 1995 | Substantially Equivalent | MYRIADLASE, INC. |
| K952636 | MEDLITE LASER SYSTEM | Jul 31, 1995 | Substantially Equivalent | CONTINUUM BIOMEDICAL, INC. |
| K952049 | TRU-PULSE PULSED CO2 SURGICAL LASER SYSTEM | Jul 21, 1995 | Substantially Equivalent | TISSUE TECHNOLOGIES, INC. |
| K951562 | OMNIPULSE-MAX HOLMIUM LASER | Jul 21, 1995 | Substantially Equivalent | TRIMEDYNE, INC. |
| K952813 | SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM | Jul 20, 1995 | Substantially Equivalent | SURGICAL LASER TECHNOLOGIES, INC. |
| K952772 | MEGABEAM ENDO-ENT PROBE | Jul 17, 1995 | Substantially Equivalent | CERAMOPTEC, INC. |
| K952299 | SURGISCAN SCANNER | Jul 17, 1995 | Substantially Equivalent | NORCROSS SCIENTIFIC |
| K951775 | CERALAS DIODE LASER SYSTEM (MODEL CERALAS D50) | Jul 17, 1995 | Substantially Equivalent | CERAMOPTEC, INC. |
| K951714 | CABOT MEDICAL-SURGITEK ULTRAGOLD PLUS SIDE-FIRING UROLOGIC LASER FIBER | Jul 11, 1995 | Substantially Equivalent | CABOT MEDICAL CORP. |
| K951812 | MODIFIED COHERENT ULTRAPULSE CO2 SURGICAL LASERS | Jul 07, 1995 | Substantially Equivalent | LUMENIS, INC. |
| K952598 | GX-PAN PANORAMIC DENTAL X-RAY SYSTEM | Jun 29, 1995 | Substantially Equivalent | GENDEX CORP. |
| K950215 | ACUTOME(R) 150 MULTI-WAVELENGTH COLOR-CORRECTED(TM) LASER HANDPIECE | Jun 15, 1995 | Substantially Equivalent | RELIANT LASER CORP. |
| K952340 | MEGABEAM ASPIRATING ENDOCULAR PROBE | Jun 12, 1995 | Substantially Equivalent | CERAMOPTEC, INC. |
| K951165 | SHARPLAN MODEL 3100 ND:YAG SURGICAL LASER SYSTEM | Jun 12, 1995 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K952301 | LASER GAS MIXTURE | Jun 01, 1995 | Substantially Equivalent | AIRGAS MANAGEMENT, INC. |
| K952162 | MEDICAL MIXTURE-LASER GAS MIXTURES | Jun 01, 1995 | Substantially Equivalent | STANDARD WELDERS SUPPLY CO. |
| K952113 | TBN-TIPPED OPTICAL FIBER | Jun 01, 1995 | Substantially Equivalent | MYRIADLASE, INC. |
| K951204 | SHARPLAN MODEL 712 ACUSPOT MICROMANIPULATOR | Jun 01, 1995 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K945564 | MODEL 550-DC CROSSFIRE(TM) | Jun 01, 1995 | Substantially Equivalent | ECLIPSE, INC. |
| K952006 | ACCU-BEAM FIBER OPTIC HANDPIECE | May 31, 1995 | Substantially Equivalent | TTI MEDICAL |
| K951933 | UROTEK RE-USABLE FIBEROPTIC CABLE | May 26, 1995 | Substantially Equivalent | ENERGY LIFE SYSTEMS CORP. |
| K950831 | ALEXLAZR | May 26, 1995 | Substantially Equivalent | CANDELA LASER CORP. |
| K945614 | ADD POWER FAMILY , MICRO ADDSTAT | May 15, 1995 | Substantially Equivalent | LASERSCOPE |
| K931490 | SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM FAMILY | May 05, 1995 | Substantially Equivalent | SURGICAL LASER TECHNOLOGIES, INC. |
| K944558 | ELLMAN VAPOR-VAC II | Apr 28, 1995 | Substantially Equivalent | NORTH AMERICAN TECHNICAL SERVICES CORP. |
| K943411 | ACCUCURE 3000 | Apr 25, 1995 | Substantially Equivalent | LASERMED |
| K951215 | LASERSONICS ULTRALINE III STERILE DISPOSABLE FIBER | Apr 18, 1995 | Substantially Equivalent | HERAEUS SURGICAL, INC. |
| K950819 | SLT SIDEFIRING REFRACTIVE FIBER (HIGH POWER DENSITY FIBER) | Apr 18, 1995 | Substantially Equivalent | SURGICAL LASER TECHNOLOGIES, INC. |
| K951034 | AURA LASER SYSTEM | Apr 13, 1995 | Substantially Equivalent | LASERSCOPE |
| K950725 | SHARPLAN MODEL 1015 CO2 LASER | Apr 06, 1995 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K950019 | THERMOLASE LT-100 ND:YAG LASER HAIR REMOVAL SYSTEM; THERMOLASE LT-100;LT-100 | Apr 03, 1995 | Substantially Equivalent | THERMOLASE CORP. |
| K951045 | LASER GAS MIXTURE | Mar 31, 1995 | Substantially Equivalent | LIQUID CARBONIC INDUSTRIAL GASES |
| K950351 | CL-5500 (UNMODIFIED DEVICE) PRECISION CURING UNIT (PCU) (MODIFIED OPTION) | Mar 24, 1995 | Substantially Equivalent | ION LASER TECHNOLOGY |
| K950313 | KAPLAN PENDULASER 115 - A 15W CO2 SURGICAL LASER | Mar 24, 1995 | Substantially Equivalent | OPTOMEDIC MEDICAL TECHNOLOGIES LTD. |
| K946386 | CANDELA RUBY LAZE Q-SWITCHED RUBY LASER | Mar 24, 1995 | Substantially Equivalent | CANDELA LASER CORP. |
| K942622 | LASEAWAY Q-SWITCHED ND:YAG LASER SYSTEM | Mar 24, 1995 | Substantially Equivalent | MDI, INC. |
| K945228 | 125MM HANDPIECE | Mar 20, 1995 | Substantially Equivalent | PLC MEDICAL SYSTEMS, INC. |
| K946304 | COHERENT FAMILY OF CO2 SURGICAL LASER SCANNER HANDPIECES | Mar 15, 1995 | Substantially Equivalent | LUMENIS, INC. |
| K944437 | DISPOSABLE LASER SWEEP TIP | Mar 14, 1995 | Substantially Equivalent | RELIANT TECHNOLOGIES, INC. |
| K943716 | LASERSONICS SURGICAL LASER SYSTEMS AND ACCESSORIES | Mar 14, 1995 | Substantially Equivalent | HERAEUS SURGICAL, INC. |
| K950710 | MICROQUARTZ MEDICAL SIDE-FIRING LASER FIBER | Mar 10, 1995 | Substantially Equivalent | MICROQUARTZ MEDICAL, INC. |
| K950662 | DERMASTAT, MICRONSPOT, MACROSPOT, FOCALSTAT | Mar 10, 1995 | Substantially Equivalent | LASERSCOPE |
| K950661 | CANDELA 10MM CIRCULAR SPOT LASER HANDPIECE | Mar 10, 1995 | Substantially Equivalent | CANDELA LASER CORP. |
| K945156 | SLASE 210 PLUS HOLMIUM LASER SYSTEM | Mar 09, 1995 | Substantially Equivalent | NEW STAR LASERS, INC. |
| K943292 | CANDELA SPTL VARIABLE PULSE/TUNABLE PULSED DYE LASERS | Mar 09, 1995 | Substantially Equivalent | CANDELA LASER CORP. |
| K943638 | USDL MODEL SELECT 1000 FREQUENCY DOUBLED ND:YAG LASER SYSTEM | Mar 06, 1995 | Substantially Equivalent | UNITED STATES DENTAL LASER, INC. |
| K943201 | CLEAN AIR | Feb 28, 1995 | Substantially Equivalent | WALLACH SURGICAL DEVICES, INC. |
| K950505 | 50MM HANDPIECE | Feb 24, 1995 | Substantially Equivalent | PLC MEDICAL SYSTEMS, INC. |
| K950248 | LASERSPRAY(TM) | Feb 24, 1995 | Substantially Equivalent | BIOLASE TECHNOLOGY, INC. |
| K945648 | ACCU-BEAM C02 LASER HANDPIECE | Feb 24, 1995 | Substantially Equivalent | TTI MEDICAL |
| K945178 | TOUCH FOCUS 200MM DEFOCUSING HANDPIECE | Feb 24, 1995 | Substantially Equivalent | PLC MEDICAL SYSTEMS, INC. |
| K946336 | MEGABEAM FIBER OPTIC DELIVERY SYSTEM | Feb 10, 1995 | Substantially Equivalent | HOGAN & HARTSON |
| K931286 | SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM | Feb 06, 1995 | Substantially Equivalent | SURGICAL LASER TECHNOLOGIES, INC. |
| K945888 | MODIFIED LUXAR LX-20 FAMILY C02 LASER SYSTEM | Jan 27, 1995 | Substantially Equivalent | LUXAR CORP. |
| K944928 | PY30, PY60, PY80 | Jan 27, 1995 | Substantially Equivalent | HUTTINGER MEDIZINTECHNIK GMBH & CO KG |
| K945181 | GENERA 100 SURGICAL SYSTEM | Jan 20, 1995 | Substantially Equivalent | XINTEC CORPORATION |
| K945560 | UROTEK LASER CATHETER | Jan 18, 1995 | Substantially Equivalent | ENERGY LIFE SYSTEMS CORP. |
| K945126 | ECLIPSE 3200 | Jan 18, 1995 | Substantially Equivalent | CARDIOGENES |
| K944965 | OPTILITE VI FIBEROPTIC ACCESSORIES | Jan 06, 1995 | Substantially Equivalent | XINTEC CORPORATION |
| K944704 | OPTILITE (TM) VII FIBEROPTIC ACCESSORIES ROTALASE (TM) ANGLE DELIVERY SYSTEMSN AND ACCESSORIES | Jan 06, 1995 | Substantially Equivalent | XINTEC CORPORATION |
| K946002 | ORIGIN PREPERITONEAL DISSECTION BALLOON SYSTEM (PDBS)--EXTRA | Jan 05, 1995 | Substantially Equivalent | ORIGIN MEDSYSTEMS, INC. |
| K944758 | SUNRISE TECHNOLOGIES MODEL 5020 PLDD KIT | Dec 27, 1994 | Unknown | CARDIOGENES |
| K944749 | OPTICA 100 SUPERPULSED LASER SYSTEM | Dec 22, 1994 | Substantially Equivalent | XINTEC CORPORATION |
| K942935 | ACUTOME 100 COLOR-CORRECTED CO2 LASER HANDPIECE | Dec 19, 1994 | Substantially Equivalent | RELIANT TECHNOLOGIES, INC. |
| K945563 | CONVERTIBLE CONTACT SIDE-FIRING REFRACTIVE FIBER (C-SRF(TM)) | Dec 15, 1994 | Substantially Equivalent | ENERGY LIFE SYSTEMS CORP. |
| K944474 | OPTILITE V FIBEROPTIC ACCESSORIES | Dec 15, 1994 | Substantially Equivalent | XINTEC CORPORATION |
| K941838 | MULTIPLE CO2 LAERS | Dec 15, 1994 | Substantially Equivalent | MATTIOLI ENGINEERING, SRL |
| K943045 | UNIMAX MODEL 2500 MULTIWAVELENGTH COLOR CORRECTED | Dec 13, 1994 | Substantially Equivalent | RELIANT TECHNOLOGIES, INC. |
| K942729 | LIHTAN 4100 KRYPTON | Dec 13, 1994 | Substantially Equivalent | LIHTAN TECHNOLOGIES, INC. |
| K945587 | CANDELA ELLIPTICAL SPOT HANDPIECE | Dec 08, 1994 | Substantially Equivalent | CANDELA LASER CORP. |
| K940173 | CANDELA Q-SWITCHED ALEXANDRITE LASER | Dec 07, 1994 | Substantially Equivalent | CANDELA LASER CORP. |
| K943527 | MEGABEAM LATERAL FIRE | Dec 05, 1994 | Substantially Equivalent | CERAMOPTEC, INC. |
| K943543 | MEDICAL OPTICS CO2 SURGICAL LASER SYSTEMS | Dec 02, 1994 | Substantially Equivalent | MEDICAL OPTIONS, INC. |
| K931445 | KTP/532, KTP/YAG AND KTP/YAG XP | Dec 02, 1994 | Substantially Equivalent | LASER SURGICAL SYSTEMS |
| K945054 | ENDOCARE PROLASE I ADVANCED LASER DELIVERY SYSTEM | Nov 28, 1994 | Substantially Equivalent | CYTOCARE, INC. |
| K944204 | LATERALASE, MODIFIED | Nov 28, 1994 | Substantially Equivalent | TRIMEDYNE, INC. |
| K942868 | ACUTOME 2000 COLOR-CORRECTED LAPAROSCOPIC C02 LASER COUPLER AND SLEEVES | Nov 14, 1994 | Substantially Equivalent | RELIANT LASER CORP. |
| K944630 | MODEL 230-SAS LASER DELIVERY PROBE | Nov 09, 1994 | Substantially Equivalent | MNLASE, INC. |
| K944153 | ECLIPSE 3200 | Nov 09, 1994 | Substantially Equivalent | CARDIOGENES |
| K944977 | COAXIAL ENDOSTAT | Nov 08, 1994 | Substantially Equivalent | LASERSCOPE |
| K944346 | LASERSONICS RADIANCE DIODE LASER SYSTEMS AND ACCESSORIES | Nov 08, 1994 | Substantially Equivalent | HERAEUS SURGICAL, INC. |
| K921995 | CANDELA H:ERB LASER | Nov 07, 1994 | Substantially Equivalent | CANDELA LASER CORP. |
| K944629 | MODEL 230-SAC LASER DELIVERY PROBE | Nov 03, 1994 | Substantially Equivalent | MNLASE, INC. |
| K944628 | MODEL 220-SS LASER DELIVERY PROBE | Nov 03, 1994 | Substantially Equivalent | MNLASE, INC. |
| K944627 | MODEL 220-SC CURVED ENDOPHOTOCOAGULATOR LASER | Nov 03, 1994 | Substantially Equivalent | MNLASE, INC. |
| K944626 | MODEL 210-AS ASPIRATING ENDOPHOTOCOAGULATOR LASER | Nov 03, 1994 | Substantially Equivalent | MNLASE, INC. |
| K944625 | MODEL 210-AC ASPIRATING ENDOPHOTOCOAGULATOR LASER | Nov 03, 1994 | Substantially Equivalent | MNLASE, INC. |
| K944471 | STRAIGHT ENDOPHOTOCOAGULATOR LASER PROBE | Nov 03, 1994 | Substantially Equivalent | MNLASE, INC. |
| K944470 | CURVED ENDOPHOTOCOAGULATOR LASER PROBE | Nov 03, 1994 | Substantially Equivalent | MNLASE, INC. |
| K941559 | PARADERM -585M DERMATOLOGICAL LASER | Nov 03, 1994 | Substantially Equivalent | PARADIGM LASERS, INC. |
| K945143 | DENTAL LASER FIBER SYSTEM | Nov 01, 1994 | Substantially Equivalent | INCISIVE TECHNOLOGIES, INC. |
| K944632 | MODEL 120-SS LASER DELIVERY PROBE | Nov 01, 1994 | Substantially Equivalent | MNLASE, INC. |
| K944631 | MODEL 120-SC LASER DELIVERY PROBE | Nov 01, 1994 | Substantially Equivalent | MNLASE, INC. |
| K944624 | MODEL 130-SAC ASPIRATING ENDOPHOTOCOAGULATOR LASER | Nov 01, 1994 | Substantially Equivalent | MNLASE, INC. |
| K944623 | MODEL 130-SAS ASPIRATING ENDOPHOTOCOAGULATOR LASER | Nov 01, 1994 | Substantially Equivalent | MNLASE, INC. |
| K944622 | MODEL 110-AS ASPIRATING ENDOPHOTOCOAGULATOR LASER | Nov 01, 1994 | Substantially Equivalent | MNLASE, INC. |
| K944621 | MODEL 110-AC ASPIRATING ENDOPHOTOCOAGULATOR LASER | Nov 01, 1994 | Substantially Equivalent | MNLASE, INC. |
| K944472 | CURVD ENDOPHOTOCOGULATOR LASER PROBE | Nov 01, 1994 | Substantially Equivalent | MNLASE, INC. |
| K944282 | LASER DELIVERY PROBE | Nov 01, 1994 | Substantially Equivalent | MNLASE, INC. |
| K944151 | OPTICAL FIBER FOR ENT APPLICATIONS | Nov 01, 1994 | Substantially Equivalent | CARDIOGENES |
| K933057 | MULTILITE ERBIUM:YAG SURGICAL LASER SYSTEM | Nov 01, 1994 | Substantially Equivalent | CONTINUUM ELECTRO-OPTICS, INC. |
| K944317 | GENESIS 2000 | Oct 11, 1994 | Substantially Equivalent | ION LASER TECHNOLOGY |
| K944206 | GENESIS 2000 | Oct 11, 1994 | Substantially Equivalent | ION LASER TECHNOLOGY |
| K944091 | THE HOOK-CURVED CLOSED END/ELECT FIBER LASER DELIV SYS | Oct 07, 1994 | Substantially Equivalent | LCA, INC. |
| K944090 | CANDELA ALEX LAZR Q-SWITCHED ALEXANDRITE LASER | Sep 30, 1994 | Substantially Equivalent | CANDELA LASER CORP. |
| K943479 | GENEMED YAG 1000 MEDICAL LASER | Sep 29, 1994 | Substantially Equivalent | GENEMED, INC. |
| K942934 | CONBIO CUB-D10 COOPER LASER SYSTEM | Sep 27, 1994 | Substantially Equivalent | CONTINUUM BIOMEDICAL, INC. |
| K943171 | CROSSFIRE(TM) (705-10650) | Sep 20, 1994 | Substantially Equivalent | CARDIOGENES |
| K942786 | KARL STORZ LASER ACCESSORIES | Sep 16, 1994 | Substantially Equivalent | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| K920596 | FULL SPECTRUM ULE FIBER, MODEL FF101 | Sep 06, 1994 | Substantially Equivalent | GERALD J. SHIRK, M.D. |
| K942542 | SLASE 210 PLUS HOLMIUM LASER SYSTEM | Sep 01, 1994 | Substantially Equivalent | SUNRISE TECHNOLOGIES, INC. |
| K934811 | PLTL-1 & PLDL-1 510NM PULSED DYE LASERS | Sep 01, 1994 | Substantially Equivalent | CANDELA LASER CORP. |
| K942759 | OPTICON(TM) CONNECTOR ADAPTER II | Aug 31, 1994 | Substantially Equivalent | XINTEC CORPORATION |
| K934501 | LASER PHOTONICS ML755 DERMABLASER | Aug 30, 1994 | Substantially Equivalent | LASER PHOTONICS, INC. |
| K943526 | MEGABEAM LATERAL FIRE FIBER OPTIC DELIVERY SYSTEM | Aug 26, 1994 | Substantially Equivalent | CERAMOPTEC, INC. |
| K943445 | MEGABEAM FIBER OPTIC DELIVERY SYSTEM | Aug 26, 1994 | Substantially Equivalent | CERAMOPTEC, INC. |
| K943444 | MEGABEAM LATERAL FIRE | Aug 26, 1994 | Substantially Equivalent | CERAMOPTEC, INC. |
| K942204 | ARGON CURING LASER | Aug 26, 1994 | Substantially Equivalent | BIO-LASER TECHNOLOGY, INC. |
| K934208 | SLT PRISM/REFRACTING PROBE | Aug 26, 1994 | Substantially Equivalent | SURGICAL LASER TECHNOLOGIES, INC. |
| K933918 | SHARPLAN MODEL 1080S CO2 SURGICAL LASER | Aug 25, 1994 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K943409 | SIDE-FIRING UROLOGIC REFRACTIVE FIBER | Aug 23, 1994 | Substantially Equivalent | ENERGY LIFE SYSTEMS CORP. |
| K942865 | LASER GAS MIXTURE | Aug 23, 1994 | Substantially Equivalent | NORDAN SMITH WELDING SUPPLIES |
| K935631 | CONBIO MEDALEX LASER SYSTEM | Aug 23, 1994 | Substantially Equivalent | CONTINUUM BIOMEDICAL, INC. |
| K943693 | PULSEMASTER S SERIES | Aug 22, 1994 | Substantially Equivalent | INCISIVE TECHNOLOGIES, INC. |
| K941841 | SMARTSCAN | Aug 15, 1994 | Substantially Equivalent | LASERSCOPE |
| K943491 | RIGHT ANGLE UROLOGIC LASER FIBER | Aug 05, 1994 | Substantially Equivalent | SURGITEK |
| K942217 | PULSEJET DENTAL LASER SYSTEM | Aug 03, 1994 | Substantially Equivalent | INCISIVE TECHNOLOGIES, INC. |
| K915236 | IRIS G-PROBE | Jul 28, 1994 | Substantially Equivalent | IRIDERM DIV. |
| K942152 | CANDELA Q-SWITCHED, FREQUENCY DOUBLED ND;YAG LASER SY | Jul 25, 1994 | Substantially Equivalent | CANDELA LASER CORP. |
| K943311 | ECLIPSE 3200 | Jul 22, 1994 | Substantially Equivalent | CARDIOGENES |
| K942343 | LASEAWAY Q-SWITCHED RUBY LASER SYSTEM | Jul 08, 1994 | Substantially Equivalent | POLYTEC PI, INC. |
| K933318 | COHERENT VERSAPULSE 2.1U /1.06U COMPACT SURGICAL LASER, MODELS A & B | Jul 08, 1994 | Substantially Equivalent | LUMENIS, INC. |
| K942182 | MEGABEAM DENTAL FIBER | Jul 06, 1994 | Substantially Equivalent | CERAM OPTEC, INC. |
| K942439 | ZEISS OPMILAS 144 SURGICAL LASERS | Jul 01, 1994 | Substantially Equivalent | ZEISS HUMPHREY SYSTEM |
| K941312 | SHARPLAN SWIFTLASE 765/766/767 FLASHSCAN | Jun 30, 1994 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K941419 | DISPOSABLE SPINAL INTRODUCER SHEATH | Jun 21, 1994 | Substantially Equivalent | TRIMEDYNE, INC. |
| K932883 | OPTILASE MODEL 1000-100 ND: YAG LASER SYSTEM | Jun 21, 1994 | Substantially Equivalent | TRIMEDYNE, INC. |
| K940461 | ALEXANTRIPTOR | Jun 02, 1994 | Substantially Equivalent | SERVICETRENDS, INC. |
| K940636 | CONBIO MEDLITE Q-SWITCHED ND:YAG LASER SYSTEM | May 31, 1994 | Substantially Equivalent | CONTINUUM BIOMEDICAL, INC. |
| K940607 | CONBIO MEDLITE Q-SWITCHED ND:YAG LASER SYSTEM | May 31, 1994 | Substantially Equivalent | CONTINUUM BIOMEDICAL, INC. |
| K941909 | MEGA BEAM LATERAL FIRE | May 23, 1994 | Substantially Equivalent | HOGAN & HARTSON |
| K936109 | SHARPLAN MODEL 1120 CO2 SURGICAL LASER | May 17, 1994 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K935563 | SHARPLAN SURGICAL CO2 LASERS AND ACCESSORIES | May 17, 1994 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K934211 | CYTOCARE DIODE LASER SYSTEM | May 17, 1994 | Substantially Equivalent | CYTOCARE, INC. |
| K941694 | ISL QC 2000 LASER | May 12, 1994 | Substantially Equivalent | INTELLIGENT SURGICAL LASERS, INC. |
| K934865 | OMNIPULSE MODEL 1210-VHP HO:YAG LASER SYSTEM | May 12, 1994 | Substantially Equivalent | TRIMEDYNE, INC. |
| K932981 | COHERENT VERSAPULSE 2.1 HOLMIUM SURGICAL LASERS | May 02, 1994 | Substantially Equivalent | COHERENT MEDICAL GROUP |
| K934706 | CANDELA PLTL-1 LASER SYSTEM: PIGMENTED LESION LASER AND TATULAZR | Apr 29, 1994 | Substantially Equivalent | CANDELA LASER CORP. |
| K933245 | ULTRALINE II STERILE DISPOSABLE FIBER | Apr 21, 1994 | Substantially Equivalent | HERAEUS LASERSONICS, INC. |
| K933211 | D'AMICO\PEYMAN FLUTED ENDOPROBE | Apr 19, 1994 | Substantially Equivalent | IRIDERM DIV. |
| K935495 | PF404/409/410/411/416/418 W/PF319:0/319:1/319:2 | Apr 18, 1994 | Substantially Equivalent | PERIMED, INC. |
| K934209 | SLT REFLECTING PROBE | Apr 08, 1994 | Substantially Equivalent | SURGICAL LASER TECHNOLOGIES, INC. |
| K933362 | SHARPLAN CO2 SURGICAL LASER | Apr 07, 1994 | Substantially Equivalent | LASER INDUSTRIES LTD. |
| K934486 | COOL LASER OPTICS (CLO) UNIT | Mar 24, 1994 | Substantially Equivalent | CYRUSCHESS |
| K935305 | CYNOSURE PHOTOTOME SURGICAL DIODE LASER | Mar 18, 1994 | Substantially Equivalent | CYNOSURE, INC. |
| K932062 | OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR | Mar 18, 1994 | Substantially Equivalent | ALCON LABORATORIES |
| K931762 | CANDELA SPTL PULSED DYE LASERS | Mar 15, 1994 | Substantially Equivalent | CANDELA LASER CORP. |
| K925178 | PEGASUS | Mar 14, 1994 | Substantially Equivalent | PREMIER LASER SYSTEMS, INC. |
| K926543 | SHARPLAN ND:YAG SURGICAL LASER, MODEL 3060 SHARPLASER 60 | Mar 09, 1994 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K924258 | MEGABEAM RADIAL EMIT SHAPE FIBER OPTIC DELIV SYST | Mar 09, 1994 | Substantially Equivalent | CERAMOPTEC, INC. |
| K933140 | RQM-1005 INTEGULASER RUBY MEDICAL LASER SYSTEM | Mar 02, 1994 | Substantially Equivalent | LASER PHOTONICS, INC. |
| K935775 | LASERSONICS CLEARPULSE MODELS 50, 70 & 100 CO2 SURGICAL LASER SYSTEMS | Mar 01, 1994 | Substantially Equivalent | HERAEUS SURGICAL, INC. |
| K933525 | DIOMED 25 25W SURGICAL DIODE LASER | Mar 01, 1994 | Substantially Equivalent | DIO-MED CORP. |
| K932730 | EXCEL'S EST-30 HO:YAG LASER SYSTEM | Mar 01, 1994 | Substantially Equivalent | EXCEL TECH. LTD. |
| K931264 | INFINITECH OTOPROBE | Mar 01, 1994 | Substantially Equivalent | INFINITECH, INC. |
| K925414 | LATERALASE CATHETER | Mar 01, 1994 | Substantially Equivalent | TRIMEDYNE, INC. |
| K925124 | TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASE SYST | Mar 01, 1994 | Substantially Equivalent | TRIMEDYNE, INC. |
| K922497 | OPTILASE ND:YAG MODELS 1000/4000 SURG LASER SYSTEM | Mar 01, 1994 | Substantially Equivalent | TRIMEDYNE, INC. |
| K922496 | TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASER SYST | Mar 01, 1994 | Substantially Equivalent | TRIMEDYNE, INC. |
| K933880 | SL SERIES SURGICAL LASER SYSTEMS | Feb 25, 1994 | Substantially Equivalent | LASERSCOPE |
| K923605 | MODIFIED SHARPLAN 1041 | Feb 23, 1994 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K933016 | CANDELA PLTL-1 LASER SYSTEM | Feb 09, 1994 | Substantially Equivalent | CANDELA LASER CORP. |
| K934389 | UROTEK LASER CATHETER | Feb 03, 1994 | Substantially Equivalent | ENERGY LIFE SYSTEMS CORP. |
| K934089 | BIO QUANTUM TECHNOLOGIES, INC. HAND-HELD CO2 LASER SYSTEM MODEL HH-550S | Feb 03, 1994 | Substantially Equivalent | BIO QUANTUM TECHNOLOGIES, INC. |
| K932723 | CONBIO CUB-D10 COPPER LASER SYSTEM | Feb 03, 1994 | Substantially Equivalent | BUCKMAN CO., INC. |
| K935258 | HYBRID SURGICAL DEVICE MODIFICATION | Jan 13, 1994 | Substantially Equivalent | LCA, INC. |
| K933007 | SLASE 210 & SLASE 210 PLUS HOLMIUM LASER SYSTEMS | Jan 10, 1994 | Substantially Equivalent | SUNRISE TECHNOLOGIES, INC. |
| K931305 | ECLIPSE 3200 FOR USE IN UROLOGY APPLICATIONS | Jan 07, 1994 | Substantially Equivalent | CARDIOGENES |
| K934008 | MEGABEAM LATERAL FIRE FIBER OPTIC DELIVERY SYST | Jan 03, 1994 | Substantially Equivalent | CERAMOPTEC, INC. |
| K935310 | MEDICAL LASER MIXTURE | Dec 23, 1993 | Substantially Equivalent | ACETYLENE GAS CO. |
| K935034 | LASER GAS MIXTURE | Dec 14, 1993 | Substantially Equivalent | TRI-GAS, INC. |
| K932376 | ZEISS OPMILAS 144 SURGICAL LASERS | Dec 14, 1993 | Substantially Equivalent | CARL ZEISS, INC. |
| K930611 | TRUE FLOW(TM) VALVE | Dec 01, 1993 | Substantially Equivalent | GM ENGINEERING, INC. |
| K934935 | ECLIPSE LAZERBLADE(TM) FIBEROPTIC DELIVERY SYSTEM | Nov 22, 1993 | Substantially Equivalent | CARDIOGENES |
| K933715 | BOSTON SCIENTIFIC CORPORATION SIDE FIRING LASER GUIDE | Nov 22, 1993 | Substantially Equivalent | BOSTON SCIENTIFIC CORP. |
| K926452 | ZEISS VISULAS YAG II LASER | Nov 22, 1993 | Substantially Equivalent | CARL ZEISS, INC. |
| K925726 | ALLOY SCALPEL HANDPIECES, MODIFICATION | Nov 22, 1993 | Substantially Equivalent | LCA, INC. |
| K911288 | ORION | Nov 16, 1993 | Substantially Equivalent | PFIZER LASER SYSTEMS |
| K910826 | ORION YAG LASER SYSTEM OPHTHALMOLOGY | Nov 16, 1993 | Substantially Equivalent | PFIZER LASER SYSTEMS |
| K930582 | SHARPLAN SHARPLASE LATERAL ND:YAG FIBER | Nov 02, 1993 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K931776 | DIOMED 25 25W SURGICAL DIODE LASER | Oct 19, 1993 | Substantially Equivalent | DIO-MED CORP. |
| K933322 | ZEISS OPMILAS 144 SURGICAL LASERS | Oct 15, 1993 | Substantially Equivalent | CARL ZEISS, INC. |
| K932421 | SURGILASE/OP 15, 20, 25, 30, 40, 50 CO2 SURG. LASE | Oct 15, 1993 | Substantially Equivalent | SURGILASE, INC. |
| K932156 | MULTILINE; DLY-1 | Oct 15, 1993 | Substantially Equivalent | DERMA-LASE CO. |
| K932272 | CLOSED END/ELECTROCAUTERY FIBEROPT LASER DELIV SYS | Oct 12, 1993 | Substantially Equivalent | LC ENT. |
| K924720 | VISIDISC KITS, SPINESCOPE | Oct 08, 1993 | Substantially Equivalent | LASERSCOPE |
| K931070 | CLOSED END FIBEROPTIC LASER DELIVERY SYSTEM | Oct 05, 1993 | Substantially Equivalent | LCA, INC. |
| K923575 | COHERENT VERSAPLUSE 2.1 HOLMIUM SURG. LASERS | Sep 29, 1993 | Substantially Equivalent | COHERENT MEDICAL GROUP |
| K933333 | HGM SCANMAN PLUS | Sep 23, 1993 | Substantially Equivalent | HGM, INC. |
| K931978 | SHARPLASE SHORT FIBER ND:YAG DELIVERY SYSTEM | Sep 23, 1993 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K931212 | DIOMED 25 25W SURGICAL DIODE LASER | Sep 23, 1993 | Substantially Equivalent | DIO-MED CORP. |
| K932468 | NOVUS MULTIWAVELENGTH | Sep 22, 1993 | Substantially Equivalent | COHERENT MEDICAL GROUP |
| K914519 | DIOMED 25 SURGICAL DIODE LASER, GYNECOLOGY APPLIC | Sep 16, 1993 | Substantially Equivalent | DIO-MED CORP. |
| K925642 | ZEISS DIODE-PUMPED SOLID STATE LASER | Sep 13, 1993 | Substantially Equivalent | CARL ZEISS, INC. |
| K931101 | ECLIPSE 2100(TM) MODEL 32, MODIFICATION | Aug 25, 1993 | Substantially Equivalent | CARDIOGENES |
| K931499 | Q-11 OPHTHALMIC LASER | Aug 19, 1993 | Substantially Equivalent | HGM, INC. |
| K930975 | DERMA-LASE DLA-1 LASER | Aug 19, 1993 | Substantially Equivalent | DERMA-LASE CO. |
| K930793 | MULTILINE; DLY-1 | Aug 19, 1993 | Substantially Equivalent | DERMA-LASE CO. |
| K920865 | SHARPLAN 2100,3000,SHARPLASER 65, 40 | Aug 02, 1993 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K930981 | ACCULITE(TM) OTOPROBE | Jul 28, 1993 | Substantially Equivalent | COHERENT MEDICAL GROUP |
| K930099 | LASER HANDPIECE SHROUD | Jul 28, 1993 | Substantially Equivalent | I.C. MEDICAL, INC. |
| K930098 | SPECULUM SMOKE EVACUATOR TUBING | Jul 28, 1993 | Substantially Equivalent | I.C. MEDICAL, INC. |
| K926210 | ECLIPSE 3200 | Jul 28, 1993 | Substantially Equivalent | CARDIOGENES |
| K933017 | MODEL 5030 SUCTION HANDPIECE SYSTEM | Jul 26, 1993 | Substantially Equivalent | SUNRISE TECHNOLOGIES, INC. |
| K931306 | ECLIPSE 3200 FOR USE IN ORTHO SURG/ARTH APPL JOINT | Jul 23, 1993 | Substantially Equivalent | CARDIOGENES |
| K932065 | DLASE 300 UPGRADE | Jul 22, 1993 | Substantially Equivalent | INCIRT TECH., INC. |
| K931774 | UPGRADED PACKAGE FOR DLASE 300 PULSED DENTAL LASER | Jul 22, 1993 | Substantially Equivalent | SUNRISE TECHNOLOGIES, INC. |
| K926224 | DIOMEDICS SURGI LIGHT/LIGHT TOUCH OPTICAL FIBERS | Jul 22, 1993 | Substantially Equivalent | DIOMEDICS, INC. |
| K924213 | ECLIPSE 2100(TM), MODIFICATION | Jul 13, 1993 | Substantially Equivalent | ELIPSE SURGICAL TECHNOLOGIES, INC. |
| K924588 | ZEISS LASER INDIRECT OPHTHALMOSCOPE | Jul 09, 1993 | Substantially Equivalent | CARL ZEISS, INC. |
| K925908 | AP01 AND AP02 | Jul 02, 1993 | Substantially Equivalent | SURGICAL LASER TECHNOLOGIES, INC. |
| K931051 | MODEL 110 ND:YAG LASER | Jun 25, 1993 | Substantially Equivalent | EXCEL TECH. LTD. |
| K925840 | ECLIPSE 3200 | Jun 25, 1993 | Substantially Equivalent | CARDIOGENES |
| K930543 | E-25 KRYPTON ION LASER (SURGICA K5) | Jun 22, 1993 | Substantially Equivalent | HGM, INC. |
| K924647 | DLR-1 DERMA-LASE RUBY LASER/DLR-1/DERMA-LASE SYST | Jun 04, 1993 | Substantially Equivalent | DERMA-LASE CO. |
| K930879 | 2.5 WATT PULSED DENTAL LASER SYSTEM | May 21, 1993 | Substantially Equivalent | SUNRISE TECHNOLOGIES, INC. |
| K930789 | 8-WATT PULSED DENTAL LASER SYSTEM | May 21, 1993 | Substantially Equivalent | SUNRISE TECHNOLOGIES, INC. |
| K924943 | ECLIPSE 3200(TM) HO:YAG LASER FOR PERCU DISKETOMY | May 17, 1993 | Substantially Equivalent | CARDIOGENES |
| K923599 | OPTILITE FIBEROPTIC DELIVERY SYSTEMS | May 17, 1993 | Substantially Equivalent | XINTEC CORPORATION |
| K924457 | MICROMANIPULATOR | May 07, 1993 | Substantially Equivalent | LASER ENGINEERING, INC. |
| K930361 | ASI CYSTOLASE LASER CYSTOSCOPE | Apr 29, 1993 | Substantially Equivalent | ADVANCED SURGICAL INTERVENTION, INC. |
| K930210 | ACL-5500 | Apr 23, 1993 | Substantially Equivalent | ILT SYSTEMS, INC. |
| K924424 | UNIMEDIX HOLMIUM FIBER | Apr 23, 1993 | Substantially Equivalent | UNIMEDIX, INC. |
| K924160 | HYBRID SURGICAL DEVICE | Apr 23, 1993 | Substantially Equivalent | LCA, INC. |
| K913566 | ARTHROSCOPIC LUMBAR MECHANICAL AND LASER DISCECTOM | Apr 20, 1993 | Substantially Equivalent | ALFRED O. BONATI, M.D. |
| K924664 | SURGILASE FIBERLASE CO2 LASER WAVEGUIDE | Apr 15, 1993 | Substantially Equivalent | SURGILASE, INC. |
| K930159 | OPTICON(TM) CONNECTOR ADAPTER | Apr 07, 1993 | Substantially Equivalent | XINTEC CORPORATION |
| K924537 | LPI ML210 HOLMIUM SURGICAL LASER | Apr 07, 1993 | Substantially Equivalent | LASER PHOTONICS, INC. |
| K922935 | CONBIO-MEDLITE Q-SWITCHED ND:YAG LASER SYSTEM | Apr 07, 1993 | Substantially Equivalent | BUCKMAN CO., INC. |
| K922577 | CONBIO-MEDLITE(TM) Q-SWITCHED ND:YAG LASER SYSTEM | Apr 07, 1993 | Substantially Equivalent | CONTINUUM BIOMEDICAL, INC. |
| K923274 | ZEISS VISULAS DIODE LASER | Apr 05, 1993 | Substantially Equivalent | CARL ZEISS, INC. |
| K930490 | SLT MULTIDIMENSIONAL CONTACT LASER SYST A4060C | Mar 31, 1993 | Substantially Equivalent | SURGICAL LASER TECHNOLOGIES, INC. |
| K923991 | ZOE LASER, CONTACT ND:YAG LASER SYSTEM | Mar 31, 1993 | Substantially Equivalent | LCA, INC. |
| K923191 | SWITCHABLE TIP SYSTEM | Mar 31, 1993 | Substantially Equivalent | TRIMEDYNE, INC. |
| K920334 | LASERPHOTONICS ML300 STONELASER ALEXANDRITE LITH. | Mar 31, 1993 | Substantially Equivalent | LASER PHOTONICS, INC. |
| K922213 | LASER-ASSISTED DISK DECOMPRESSION ACCESSORY PACK | Mar 20, 1993 | Substantially Equivalent | TRIMEDYNE, INC. |
| K924120 | MOLDED FIBER CAP DELIVERY SYSTEM | Mar 19, 1993 | Substantially Equivalent | LCA, INC. |
| K925549 | SLASE 210 PLUS HOLMIUM LASER SYSTEM | Mar 09, 1993 | Substantially Equivalent | SUNRISE TECHNOLOGIES, INC. |
| K910825 | ORION YAG LASER SYSTEM EAR, NOSE, & THROAT APPLIC. | Feb 26, 1993 | Substantially Equivalent | PFIZER LASER SYSTEMS |
| K924644 | ENDOSTATS, MICROSTATS, ACCUSTATS | Feb 23, 1993 | Substantially Equivalent | LASERSCOPE |
| K921549 | DORNIER FIBERTOME 100 WATT SURGICAL LASER | Feb 18, 1993 | Substantially Equivalent | DORNIER MEDTECH AMERICA, INC. |
| K924166 | OPTILINK(TM) LPM (LASER POWER MODULATOR) | Feb 05, 1993 | Substantially Equivalent | XINTEC CORPORATION |
| K914520 | DIOMED 25 SURGICAL DIODE LASER, UROLOGY APPLICAT | Jan 22, 1993 | Substantially Equivalent | DIO-MED CORP. |
| K924729 | EXCEL TRIPULSE MODEL3000 | Jan 15, 1993 | Substantially Equivalent | EXCEL TECH. LTD. |
| K924158 | CANDELA LASSER SYSTEMS MODIFIED | Jan 15, 1993 | Substantially Equivalent | CANDELA LASER CORP. |
| K914521 | DIOMED 25 SURGICAL DIODE LASER, GEN SURG APPLICAT | Jan 15, 1993 | Substantially Equivalent | DIO-MED CORP. |
| K923855 | SHARPULSE | Dec 24, 1992 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K922807 | FIBERLIFE | Dec 15, 1992 | Substantially Equivalent | LASER SURGICAL SYSTEMS |
| K923896 | HERCULES MODEL 5060 AND 5100 ND:YAG LASER SYSTEMS | Nov 25, 1992 | Substantially Equivalent | HERAEUS LASERSONICS, INC. |
| K922901 | INCISOR I PULSED ND:YAG LASER SYSTEM | Nov 20, 1992 | Substantially Equivalent | BUCKMAN CO., INC. |
| K923953 | MEGABEAM | Nov 17, 1992 | Substantially Equivalent | CERAMOPTEC, INC. |
| K924214 | ECLIPSE 2100(TM) MODEL 32 | Nov 16, 1992 | Substantially Equivalent | CARDIOGENES |
| K922881 | CLARUS MODELS 1100, 1101, 1102, 1103 LASER DISC | Nov 16, 1992 | Unknown | CLARUS MEDICAL SYSTEMS, INC. |
| K914334 | ALCON(R) FX2(TM) PHOTOCOAGULATOR | Nov 13, 1992 | Substantially Equivalent | ALCON LABORATORIES |
| K920708 | MULTILASE 2500 A | Nov 05, 1992 | Substantially Equivalent | TEKNOMED, INC. |
| K913917 | MULTILASE 2100 C, 2100 D | Nov 05, 1992 | Substantially Equivalent | TEKNOMED, INC. |
| K923539 | AMERICAN DENTAL LASER SINGLE USE CONTACT 320 HANDP | Oct 28, 1992 | Substantially Equivalent | AMERICAN DENTAL LASER, INC. |
| K923341 | ZEISS VISULAS ARGON LASER | Oct 28, 1992 | Substantially Equivalent | CARL ZEISS, INC. |
| K921990 | ASI UROPLASTY LASER CYSTOSCOPE | Oct 28, 1992 | Substantially Equivalent | ADVANCED SURGICAL INTERVENTION, INC. |
| K923683 | CYNOSURE PHOTOGENICA T TATTOO REMOVAL LASER | Oct 15, 1992 | Substantially Equivalent | CYNOSURE, INC. |
| K921300 | MODEL PC ARGON ION LASER | Oct 06, 1992 | Substantially Equivalent | HGM MEDICAL LASER SYSTEMS, INC. |
| K921708 | CYTOCARE LASER CATHETER FOR UROLOGY | Oct 01, 1992 | Substantially Equivalent | CYTOCARE, INC. |
| K922917 | ENDOPROBES | Sep 28, 1992 | Substantially Equivalent | ENDOOPTIKS, INC. |
| K914678 | ODYSSEY HO:YAG SURGICAL LASER SYSTEM | Sep 21, 1992 | Substantially Equivalent | XINTEC CORPORATION |
| K913990 | KTP/532 & KTP/YAG | Sep 02, 1992 | Substantially Equivalent | LASERSCOPE |
| K921843 | CYNOSURE PHOTODENT, INTRAORAL SURGICAL LASER | Aug 14, 1992 | Substantially Equivalent | CYNOSURE, INC. |
| K920673 | PERCUDISC PLDD DELIVERY SYSTEM/PROCEDURE KIT | Aug 13, 1992 | Unknown | PERCUDISC, INC. |
| K922663 | IRIS OCULIGHT SL | Aug 11, 1992 | Substantially Equivalent | IRIDERM DIV. |
| K921841 | CYNOSURE PHOTOGENICA P PIGMENTED LESION LASER | Aug 04, 1992 | Substantially Equivalent | CYNOSURE, INC. |
| K923050 | ND:YAG LASER-12 | Aug 03, 1992 | Substantially Equivalent | LASER ENDO TECHNIC |
| K921096 | LASER-6 | Jul 28, 1992 | Substantially Equivalent | LASER ENDO TECHNIC |
| K913244 | KTP/532 & KTP/YAG SURGICAL LASERS | Jul 28, 1992 | Substantially Equivalent | CHARLES L. ROSE AND CO., INC. |
| K914918 | LASERSCOPE'S MICROSPOT DERMASTAT | Jul 24, 1992 | Substantially Equivalent | LASERSCOPE |
| K914136 | COHERENT VERSAPULSE(TM) 2.1XE/2.1L HOLMI SURG LASE | Jul 21, 1992 | Substantially Equivalent | COHERENT MEDICAL GROUP |
| K921840 | CYNOSURE PHOTOTRIPTER LASER | Jul 16, 1992 | Substantially Equivalent | CYNOSURE, INC. |
| K922634 | SLT LASER DELIVERY SYSTEM | Jul 15, 1992 | Substantially Equivalent | SURGICAL LASER TECHNOLOGIES, INC. |
| K922375 | EXCEL DUOPULSE MODEL 3000 COMBINATION HO/ER:YAG | Jul 08, 1992 | Substantially Equivalent | EXCEL TECH. LTD. |
| K921842 | CYNOSURE PHOTGENICA V CUTANEOUS VAS. LESION LASER | Jul 08, 1992 | Substantially Equivalent | CYNOSURE, INC. |
| K920967 | ZEISS MULTI YAG LASER | Jul 08, 1992 | Substantially Equivalent | CARL ZEISS, INC. |
| K921320 | ELIOS DIODE OPHTHALMIC LASER | Jul 02, 1992 | Substantially Equivalent | MARCO OPHTHALMIC, INC. |
| K921298 | MODEL MM-2405 AND MM-2410 COPPER VAPOR LASER | Jul 02, 1992 | Substantially Equivalent | CJ LASER CORP. |
| K921380 | LASERSCOPE'S DISPOSABLE LAPAROSTAT W/ FIBER DIVER | Jun 25, 1992 | Substantially Equivalent | LASERSCOPE |
| K915679 | EXCEL DUOPAULSE MODEL 2000 | Jun 24, 1992 | Substantially Equivalent | EXCEL TECH. LTD. |
| K921807 | ULTRALINE STERILE DISPOSABLE FIBER | Jun 18, 1992 | Substantially Equivalent | HERAEUS LASERSONICS, INC. |
| K921671 | SURGILASE FIBERLASE VCO2 LASER WAVEGUIDE | Jun 18, 1992 | Substantially Equivalent | SURGICAL PRODUCTS CORP. |
| K912067 | POLARIS, GYNECOLOGY INDICATIONS | Jun 16, 1992 | Substantially Equivalent | PFIZER LASER SYSTEMS |
| K915651 | OMNIMED HOLMIUM LASER AND DELIVERY SYSTEM | Jun 15, 1992 | Substantially Equivalent | SUMMIT TECHNOLOGY, INC. |
| K915631 | LPI ML 100/532 AND ML 532 SURGICAL LASER | Jun 15, 1992 | Substantially Equivalent | LASER PHOTONICS, INC. |
| K915578 | ND;YAG SURGICAL LASER SYSTEMS | Jun 15, 1992 | Substantially Equivalent | HERAEUS LASERSONICS, INC. |
| K921146 | SHARPLAN CO2 SURG. LASER, MO. 1039 SURGICENTER 40 | Jun 08, 1992 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K920659 | DAVOL ENDO-FLO LASER PROBE AND ACCESSORIES | Jun 05, 1992 | Substantially Equivalent | DAVOL, INC. |
| K920062 | CANDELA PLTL-1 LASER SYSTEM: PIGMENTED LESION LAS. | Jun 05, 1992 | Substantially Equivalent | CANDELA LASER CORP. |
| K921038 | ECLIPSE 2100 | Jun 04, 1992 | Substantially Equivalent | CARDIOGENES |
| K920597 | HANDI-LASE CO2 SURGICAL LASER INSTRUMENT | Jun 04, 1992 | Substantially Equivalent | SORENSON LABORATORIES, INC. |
| K920821 | UNIMAX MODEL 2000 COLOR-CORRECTED MICROSPOT CO2 | May 21, 1992 | Substantially Equivalent | RELIANT LASER CORP. |
| K920004 | PBI MULTILASE D COPPER VAPOR LASER | May 14, 1992 | Substantially Equivalent | WM.I.KERN & CO., INC. |
| K921596 | SHARPLAN C02 ULTRASWIFT VAPORIZATION ENDPIECE | May 13, 1992 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K914991 | VERSAPULSE(TM) TWOPOINTONE/XE HOLMIUM SURG LASERS | May 06, 1992 | Substantially Equivalent | COHERENT MEDICAL GROUP |
| K920934 | HALOCATH LASER CATHETERS | Apr 29, 1992 | Substantially Equivalent | TRIMEDYNE, INC. |
| K920589 | ANGLED DELIVERY DEVICE | Apr 29, 1992 | Substantially Equivalent | LASERSCOPE |
| K910422 | MODEL RD-1200 RUBY LASER SYSTEM | Apr 21, 1992 | Substantially Equivalent | SPECTRUM MEDICAL TECHNOLOGIES, INC. |
| K910152 | ORION | Apr 15, 1992 | Substantially Equivalent | PFIZER LASER SYSTEMS |
| K920584 | SCULPTURED ENDOSTAT | Apr 10, 1992 | Substantially Equivalent | LASERSCOPE |
| K920120 | ND:YAG SURGICAL LASER | Apr 10, 1992 | Substantially Equivalent | CARL ZEISS, INC. |
| K915656 | CARBON DIOXIDE CO2 LASER | Apr 10, 1992 | Substantially Equivalent | ION LASER TECHNOLOGY |
| K914197 | ALLOY SCALPEL HANDPIECES | Apr 10, 1992 | Substantially Equivalent | LASER, INC. |
| K914679 | PRODIGY ND:YAG SURGICAL LASER SYSTEM | Apr 07, 1992 | Substantially Equivalent | XINTEC CORPORATION |
| K920632 | SIDE FIRING FIBERS | Apr 02, 1992 | Substantially Equivalent | TRIMEDYNE, INC. |
| K920625 | LATERALASE | Apr 02, 1992 | Substantially Equivalent | TRIMEDYNE, INC. |
| K920529 | ZEISS MULTIYAG LASER | Apr 02, 1992 | Substantially Equivalent | CARL ZEISS, INC. |
| K915169 | EXCEL MODEL XLT-TWO HOLMIUM:YAG LASER SYSTEM | Apr 02, 1992 | Substantially Equivalent | EXCEL TECH. LTD. |
| K915117 | MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEM | Apr 02, 1992 | Substantially Equivalent | TRIMEDYNE, INC. |
| K914518 | KTP/YAG AND KTP/YAG PLUS | Apr 02, 1992 | Substantially Equivalent | LASERSCOPE |
| K915583 | CO2 LASER AND WAVEGUIDE DELIVERY SYSTEMS FOR THOR. | Mar 27, 1992 | Substantially Equivalent | HERAEUS LASERSONICS, INC. |
| K914827 | LPI ML210 HOLMIUM SURGICAL LASER, MODIFICATION | Mar 27, 1992 | Substantially Equivalent | LASER PHOTONICS, INC. |
| K920553 | MYRIADLASE SIDEFIRE-TIPPED OPTICAL FIBER | Mar 26, 1992 | Substantially Equivalent | MYRIAD LASE, INC. |
| K915840 | ZEISS MULTIYAG LASER | Mar 23, 1992 | Substantially Equivalent | CARL ZEISS, INC. |
| K920107 | ADL 800 ND:YAG LASER SYSTEM FOR INTRAORAL TIS. SUR | Mar 13, 1992 | Substantially Equivalent | SUNRISE TECHNOLOGIES, INC. |
| K920106 | ADL 400 ND;YAG LASER SYSTEM FOR INTRORAL SOFT TIS. | Mar 13, 1992 | Substantially Equivalent | SUNRISE TECHNOLOGIES, INC. |
| K913839 | OPTICA 25 ND:YAG DENTAL LASER SYSTEM | Mar 13, 1992 | Substantially Equivalent | XINTEC CORPORATION |
| K915561 | ZEISS MULTIYAG LASER | Mar 11, 1992 | Substantially Equivalent | CARL ZEISS, INC. |
| K914455 | SHARPLAN MODELS 100 SERIES C02 LASERS/ACCESSORIES | Mar 11, 1992 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K915497 | CONBIO MEDLITE Q-SWITCHED ND:YAG LASER SYSTEM | Mar 06, 1992 | Substantially Equivalent | CONTINUUM BIOMEDICAL, INC. |
| K915085 | DL100 C02 SURGICAL LASER SYSTEM | Feb 28, 1992 | Substantially Equivalent | MNLASE, INC. |
| K912618 | LASER SYSTEMS FOR PERCUTANEOUS LUMBAR DISCECTOMY | Feb 27, 1992 | Substantially Equivalent | HERAEUS LASERSONICS, INC. |
| K914849 | EXCEL MODEL XLT-ONE ND:YAG LASER SYSTEM | Feb 25, 1992 | Substantially Equivalent | EXCEL TECH. LTD. |
| K915354 | LATERALASE | Feb 24, 1992 | Substantially Equivalent | TRIMEDYNE, INC. |
| K913290 | MULTILASE 2100 A | Feb 21, 1992 | Substantially Equivalent | TEKNOMED, INC. |
| K912879 | MODEL SLASE 210 HOLMIUM (THC:YAG) LASER SYSTEM | Feb 21, 1992 | Substantially Equivalent | SUNRISE TECHNOLOGIES, INC. |
| K915768 | SURGI LIGHT ND:YAG LASER SYSTEM MODEL 904030 | Feb 11, 1992 | Substantially Equivalent | SURGICAL LASER PRODUCTS, INC. |
| K915370 | COPPER VAPOR LASER SYSTEM | Feb 07, 1992 | Substantially Equivalent | METATECH CORP. |
| K915000 | ACU-GUARD | Jan 27, 1992 | Substantially Equivalent | ACUDERM, INC. |
| K915223 | METAL ENCLOSED SIDE FIRING FIBERS | Jan 23, 1992 | Substantially Equivalent | TRIMEDYNE, INC. |
| K913256 | DERMA-LASE RUBY LASER - MODEL DLR-1 | Jan 22, 1992 | Substantially Equivalent | DERMA-LASE CO. |
| K912813 | SIRIUS | Dec 31, 1991 | Substantially Equivalent | PFIZER LASER SYSTEMS |
| K910823 | PERCUDISC(TM) SYSTEM | Dec 30, 1991 | Substantially Equivalent | PERCUDISC, INC. |
| K914396 | SURGI LIGHT NON-CONTACT FIBERS | Dec 23, 1991 | Substantially Equivalent | LIFESTREAM INT'L, INC. |
| K914952 | MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEM | Dec 20, 1991 | Substantially Equivalent | TRIMEDYNE, INC. |
| K913606 | CHRYS XX CO2 SURGICAL LASER SYSTEM | Dec 19, 1991 | Substantially Equivalent | JAMAR MEDICAL SYSTEMS |
| K915352 | LASER FIBEROPTIC DELIVERY SYSTEM | Dec 17, 1991 | Substantially Equivalent | SUNRISE TECHNOLOGIES, INC. |
| K914726 | ILT CO2 SURGICAL LASER FOR ORAL SOFT TISSUE PROCED | Dec 17, 1991 | Substantially Equivalent | ION LASER TECHNOLOGY |
| K914175 | MICROSURGE LASER FIBER WITH SMA CONNECTOR | Dec 17, 1991 | Substantially Equivalent | MICROSURGE, INC. |
| K913887 | C02 LASER WAVEGUIDE | Dec 09, 1991 | Substantially Equivalent | HERAEUS LASERSONICS, INC. |
| K914089 | SHARPLAN SHARPLASE FAMILY OF HANDSWITCHED ND:YAG | Dec 06, 1991 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K914423 | OPTIFIBER | Dec 02, 1991 | Substantially Equivalent | MINIMAL INVASIVE THERAPY AND DIAGNOSTICS, INC. |
| K913758 | KTP/532 AND KTP/YAG | Nov 20, 1991 | Substantially Equivalent | LASERSCOPE |
| K913430 | IRIS OCULIGHT(R) SLX | Nov 15, 1991 | Substantially Equivalent | IRIDERM DIV. |
| K914677 | MODEL DLASE 500 ND:YAG LASE SYS:INTRA SFT TIS SURG | Nov 08, 1991 | Substantially Equivalent | SUNRISE TECHNOLOGIES, INC. |
| K914568 | MODEL DLASER 1000 ND;YAG LASER SYSTEM | Nov 07, 1991 | Substantially Equivalent | SUNRISE TECHNOLOGIES, INC. |
| K911926 | POLARIS, OPHTHALMOLOGY | Nov 07, 1991 | Substantially Equivalent | PFIZER LASER SYSTEMS |
| K910530 | CARBON DIOXIDE LASER SYSTEMS W/WAVEGUIDE DELIVERY | Oct 31, 1991 | Substantially Equivalent | HERAEUS LASERSONICS, INC. |
| K912987 | CRYSTAL FOCUS EMER LASER PHOTO VIS RED OPER MODE | Oct 28, 1991 | Substantially Equivalent | DOUGLAS JAMES DONALDSON COMPLIANCE SERVICES |
| K913465 | NIDEK MODELS AC-2100 & 2200 | Oct 21, 1991 | Substantially Equivalent | NIDEK, INC. |
| K913569 | COMPAC A, ELITE A, ELITE A PLUS, SURGICA A | Oct 17, 1991 | Substantially Equivalent | HGM MEDICAL LASER SYSTEMS, INC. |
| K913191 | DORNIER LASER LITHOTRIPTER IMPACT | Oct 16, 1991 | Substantially Equivalent | DORNIER MEDTECH AMERICA, INC. |
| K912063 | POLARIS, ORAL INDICATION | Oct 16, 1991 | Substantially Equivalent | PFIZER LASER SYSTEMS |
| K912703 | OPTICA 60 ND;YAG SURGICAL LASER SYSTEM | Oct 11, 1991 | Substantially Equivalent | XINTEC CORPORATION |
| K911925 | POLARIS, GASTROENTEROLOGY/UROLOGY/PULMONARY, GI/GU | Oct 11, 1991 | Substantially Equivalent | PFIZER LASER SYSTEMS |
| K910341 | POLARIS | Oct 11, 1991 | Substantially Equivalent | PFIZER LASER SYSTEMS |
| K913127 | COHERENT NOVUS 3000 ARGON PHOTOCOAGULATOR | Oct 08, 1991 | Substantially Equivalent | COHERENT MEDICAL GROUP |
| K913109 | LATERALASE(TM) CATHETER WITH THERMAL FEEDBACK | Oct 08, 1991 | Substantially Equivalent | TRIMEDYNE, INC. |
| K914104 | ENDOSTAT | Sep 27, 1991 | Substantially Equivalent | LASERSCOPE |
| K913918 | HERAEUS LASERSONICS TACTILASE STERILE DISPOS FIBER | Sep 25, 1991 | Substantially Equivalent | HERAEUS LASERSONICS, INC. |
| K910037 | COHERENT HOLMIUM:YAG SURGICAL LASER | Sep 25, 1991 | Substantially Equivalent | COHERENT MEDICAL GROUP |
| K910027 | CRYSTAL FOCUS EMERALD LASER SLT MCX 1.5 CONVEX PRO | Sep 25, 1991 | Substantially Equivalent | BIOVISION, INC. |
| K912793 | SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM (CLS) | Sep 18, 1991 | Substantially Equivalent | SURGICAL LASER TECHNOLOGIES, INC. |
| K913564 | HERCULES 5000 AND HERCULES 5040 ND:YAG LASER SYSTE | Sep 16, 1991 | Substantially Equivalent | HERAEUS LASERSONICS, INC. |
| K912628 | AIR ARGON ION LASERS VARIOUS MODELS | Sep 13, 1991 | Substantially Equivalent | HGM MEDICAL LASER SYSTEMS, INC. |
| K913513 | LATERALASE STERILE DISPOSABLE FIBER | Sep 11, 1991 | Substantially Equivalent | HERAEUS LASERSONICS, INC. |
| K913488 | STI CONTACT 200 FIBEROPTIC DELIVERY SYSTEM | Sep 10, 1991 | Substantially Equivalent | SUNRISE TECHNOLOGIES, INC. |
| K913037 | SHARPLAN SHARPLASE FAMILY ND:YAG SCULPTED FIBERS | Sep 06, 1991 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K912538 | KTP/YAG PLUS | Sep 06, 1991 | Substantially Equivalent | LASERSCOPE |
| K911457 | TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASER SYST | Sep 05, 1991 | Substantially Equivalent | TRIMEDYNE, INC. |
| K912792 | SHARPLAN ND:YAG SURG.LASER,MODEL 3040 SHARPLASER | Aug 29, 1991 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K912918 | IRIS OCULIGHT DIODE LASER ADDING SLIT LAMP ADAPTER | Aug 23, 1991 | Substantially Equivalent | IRIDERM DIV. |
| K912332 | MICROSURGE LASER FIBER HOLDER | Aug 21, 1991 | Substantially Equivalent | MICROSURGE, INC. |
| K912284 | BIOVISION ENDOCULAR PROBE ACCESS DELIV SYST, MODIF | Aug 19, 1991 | Substantially Equivalent | DOUGLAS JAMES DONALDSON COMPLIANCE SERVICES |
| K910062 | 02-10,001 | Aug 16, 1991 | Substantially Equivalent | LASER ENGINEERING, INC. |
| K911830 | LASERSCOPE(R) KTP/532 AND KTP/YAG SURGICAL LASER | Aug 14, 1991 | Substantially Equivalent | LASERSCOPE |
| K912029 | ULTRAPULSE(TM) CARBON DIOXIDE SURGICAL LASER | Aug 13, 1991 | Substantially Equivalent | COHERENT MEDICAL GROUP |
| K911987 | LUXUS 132 ND: YAG SURGICAL LASER SYSTEM | Aug 13, 1991 | Substantially Equivalent | HERAEUS LASERSONICS, INC. |
| K910272 | HGM COMBINATION ND:YAG & SOLID STATE GREEN | Aug 09, 1991 | Substantially Equivalent | HGM MEDICAL LASER SYSTEMS, INC. |
| K905802 | CENTAURI/PEGASUS | Jul 19, 1991 | Substantially Equivalent | PFIZER LASER SYSTEMS |
| K912438 | MODELS 5,8,20,20S ARGON ION LASERS | Jul 17, 1991 | Substantially Equivalent | HGM MEDICAL LASER SYSTEMS, INC. |
| K904632 | CENTAURI YAG LASER SYST, GYNECOLOGY | Jul 11, 1991 | Substantially Equivalent | PFIZER LASER SYSTEMS |
| K911150 | SOREX SAFE-AIR | Jun 28, 1991 | Substantially Equivalent | SOREX MEDICAL |
| K910602 | HGM ARGON ION & SOLID LIGHT LASER FOR DENTISTRY | Jun 24, 1991 | Substantially Equivalent | HGM MEDICAL LASER SYSTEMS, INC. |
| K903418 | LATERALASE TM | Jun 24, 1991 | Substantially Equivalent | TRIMEDYNE, INC. |
| K895363 | BIOVISION EMERALD LASER PHOTOCOAGULATOR | Jun 24, 1991 | Substantially Equivalent | F.I.T. OF FRANCE |
| K904631 | CENTAURI YAG LASER SYST, NEUROSURGERY | Jun 18, 1991 | Substantially Equivalent | PFIZER LASER SYSTEMS |
| K905737 | CENTAURI/PEGASUS | Jun 17, 1991 | Substantially Equivalent | PFIZER LASER SYSTEMS |
| K911852 | COMPULSE CO2 SURGICAL LASER SYS. | Jun 07, 1991 | Substantially Equivalent | LASER ENGINEERING, INC. |
| K911408 | CROSSFIRE LASER ASSISTED ASPIRATION CANNULA | Jun 03, 1991 | Substantially Equivalent | HERAEUS LASERSONICS, INC. |
| K910898 | SURGICA(TM) H | May 31, 1991 | Substantially Equivalent | HGM MEDICAL LASER SYSTEMS, INC. |
| K910200 | LASER-35 | May 09, 1991 | Substantially Equivalent | ENDO TECHNIC CORP. |
| K910496 | CARBON DIOXIDE LASER SYSTEMS W/ARTHOGUIDE CO2 DEL. | May 06, 1991 | Substantially Equivalent | HERAEUS LASERSONICS, INC. |
| K911523 | MODIFICATION TO MODEL 90-1460 LASER ADAPTER | Apr 22, 1991 | Substantially Equivalent | LIFESTREAM INT'L, INC. |
| K910894 | HERAEUS LASERSONIC, INC STERILE DISPOSABLE FIBERS | Apr 22, 1991 | Substantially Equivalent | HERAEUS LASERSONICS, INC. |
| K905676 | MD CO2 SURGICAL LASER SYSTEM/GEN. SURGERY AND ORTH | Apr 22, 1991 | Substantially Equivalent | LASER ENGINEERING, INC. |
| K904841 | LPI YAG MODEL 1003 SURGICAL LASER SYST/MODIFIED | Apr 19, 1991 | Substantially Equivalent | LASER PHOTONICS, INC. |
| K904068 | LUXAR MODEL LX-20 CO2 LASER | Apr 15, 1991 | Substantially Equivalent | LUXAR CORP. |
| K910233 | LASER PHOTONICS ML-210 HOLMIUM:YAG MEDI LASE SYST | Apr 12, 1991 | Substantially Equivalent | LASER PHOTONICS, INC. |
| K910114 | OPTILITE (TM) FIBEROPTIC DELIVERY SYSTEMS AND ACCE | Apr 09, 1991 | Substantially Equivalent | XINTEC CORPORATION |
| K910137 | PLP LAPAROSCOPIC CHOLECYSTECTOMY SET | Apr 08, 1991 | Substantially Equivalent | PRECISION LASER PRODUCTS, INC. |
| K910051 | SHARPLAN ND:YAG SURG LASER, 3065, SHARPLASER 65 | Apr 08, 1991 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K904420 | DISPOSABLE FIBER OPTIC DELIVERY SYSTEM | Apr 08, 1991 | Substantially Equivalent | FIBER DELIVERY CONCEPTS, INC. |
| K910726 | LIGHT-TOUCH AND SURGI LIGHT FIBERS | Mar 29, 1991 | Substantially Equivalent | LIFESTREAM INT'L, INC. |
| K905708 | TRIMEDYNE MODEL 1210 OMNIPULSE LASER SYSTEM | Mar 28, 1991 | Substantially Equivalent | TRIMEDYNE, INC. |
| K904930 | SURGICAL CARBON DIOXIDE LASER SYST MODEL 20-CH | Mar 21, 1991 | Substantially Equivalent | DIRECTED ENERGY, INC. |
| K905511 | CODMAN NEUROLASE LASER SYSTEM/MODIFICATION | Mar 05, 1991 | Substantially Equivalent | I.L. MED, INC. |
| K903838 | OPTILASE (TM) MODEL 900 ARGON | Mar 05, 1991 | Substantially Equivalent | TRIMEDYNE, INC. |
| K905424 | KTP DISC KIT | Mar 04, 1991 | Substantially Equivalent | LASERSCOPE |
| K905006 | SURGILASE SL 150 SURGICAL LASER SYSTEM | Feb 21, 1991 | Substantially Equivalent | SURGILASE, INC. |
| K904700 | ENDOCOAGULATOR KRS568(TM) LASER | Feb 19, 1991 | Substantially Equivalent | HGM MEDICAL LASER SYSTEMS, INC. |
| K904266 | AUTODERM SCANNER CONTROL CONSOLE | Feb 19, 1991 | Substantially Equivalent | CHARLES I. ROSE & CO., INC. |
| K903131 | LASERMATIC SUPERCOMBO(TM) SURGICAL LASER SYSTEM | Feb 19, 1991 | Substantially Equivalent | LASERMATIC, INC. |
| K905072 | ALTAIR | Feb 07, 1991 | Substantially Equivalent | PFIZER LASER SYSTEMS |
| K903639 | NIDEK DC-3000 DIODE LASER PHOTOCOAGULATOR | Feb 04, 1991 | Substantially Equivalent | NIDEK, INC. |
| K905082 | PEGASUS WITH ACCESSORIES | Jan 31, 1991 | Substantially Equivalent | PFIZER LASER SYSTEMS |
| K904911 | DISPOSABLE FIBER OPTIC DELIVERY SYSTEM | Jan 25, 1991 | Substantially Equivalent | FIBER DELIVERY CONCEPTS, INC. |
| K905637 | ILLUMINA MODEL 780 CO2 LASER SYSTEM | Jan 18, 1991 | Substantially Equivalent | HERAEUS LASERSONICS, INC. |
| K905233 | MOOR LASER BLOOD FLOW MONITOR MBF3D | Jan 11, 1991 | Substantially Equivalent | MOOR INSTRUMENTS LTD. |
| K905232 | MOOR LASER BLOOD FLOW MONITOR MBF3 | Jan 11, 1991 | Substantially Equivalent | MOOR INSTRUMENTS LTD. |
| K904629 | CENTAURI YAG LASER SYST, UROLOGY | Jan 07, 1991 | Substantially Equivalent | PFIZER LASER SYSTEMS |
| K904628 | CENTAURI YAG LASER SYST, GASTROENTEROLOGY | Jan 07, 1991 | Substantially Equivalent | PFIZER LASER SYSTEMS |
| K904627 | CENTAURI YAG LASER SYST, EAR, NOSE , THROAT | Jan 07, 1991 | Substantially Equivalent | PFIZER LASER SYSTEMS |
| K904610 | HERCULES MODEL 5000 AND 5040 ND:YAG LASER SYSTEMS | Dec 19, 1990 | Substantially Equivalent | HERAEUS LASERSONICS, INC. |
| K904354 | LPI MULILASE YAG/532 SURGICAL LASER SYSTEM | Dec 19, 1990 | Substantially Equivalent | LASER PHOTONICS, INC. |
| K904342 | SERIES 1990 ARGON SURGICAL LASERS, E1,E6,E14&E20A | Dec 19, 1990 | Substantially Equivalent | HGM MEDICAL LASER SYSTEMS, INC. |
| K904407 | DISPOSABLE FIBER OPTIC DELIVERY SYST/ND: YAG SURG | Dec 18, 1990 | Substantially Equivalent | FIBER DELIVERY CONCEPTS, INC. |
| K904630 | CENTAURI YAG LASER SYST, OPHTHAMOLOGY | Dec 17, 1990 | Substantially Equivalent | PFIZER LASER SYSTEMS |
| K904331 | L.P.I. LASER DELIVERY SYSTEM | Dec 17, 1990 | Substantially Equivalent | LASER PHOTONICS, INC. |
| K904444 | MODELS 4000,4900,6000,8000,8900, LUXUS 6&100/1700 | Dec 13, 1990 | Substantially Equivalent | HERAEUS LASERSONICS, INC. |
| K904423 | CO2 LASERS AND INFRAGUIDE DELIVERY SYSTEM | Dec 13, 1990 | Substantially Equivalent | HERAEUS LASERSONICS, INC. |
| K904229 | MULTILASE 60 | Dec 12, 1990 | Substantially Equivalent | LASER PHOTONICS, INC. |
| K904227 | MULTILASE 45 | Dec 12, 1990 | Substantially Equivalent | LASER PHOTONICS, INC. |
| K904402 | NIDEK INC. MODEL AC-2000 DERM | Dec 07, 1990 | Substantially Equivalent | NIDEK, INC. |
| K904203 | SURGILASE SL 50/60 GOLD SURGICAL LASER SYSTEM | Dec 07, 1990 | Substantially Equivalent | SURGILASE, INC. |
| K904149 | FLEXISYS | Dec 04, 1990 | Substantially Equivalent | DORNIER MEDTECH AMERICA, INC. |
| K903154 | CONTACT FIBERS,SURGICAL PROBES & NON-CONTACT FIBER | Nov 23, 1990 | Substantially Equivalent | TRIMEDYNE, INC. |
| K904155 | MEDILAS 4060N FIBERTOM(R) SURGICAL LASER | Nov 21, 1990 | Substantially Equivalent | DORNIER MEDTECH AMERICA, INC. |
| K903943 | MODEL MC 1100 SURGICAL YAG LASER | Nov 21, 1990 | Substantially Equivalent | KLINGER MICRO-CONTROLE GROUP |
| K904067 | LASERSAT CO2 | Nov 07, 1990 | Substantially Equivalent | SATELEC |
| K904126 | VISIRASER | Oct 30, 1990 | Substantially Equivalent | ACORN GROUP, INC. |
| K903936 | SLT CONTACT LASER SYSTEM ND:YAG MEDICAL LASER SYST | Oct 26, 1990 | Substantially Equivalent | SURGICAL LASER TECHNOLOGIES, INC. |
| K904162 | CARBON DIOXIDE FLOWTHROUGH LASER MIXTURES | Oct 19, 1990 | Substantially Equivalent | NORCO, INC. |
| K903444 | MDLS 4000/4900/6000/8000/8900/LUXUS 60/100 ND:YAG | Oct 11, 1990 | Substantially Equivalent | HERAEUS LASERSONICS, INC. |
| K903230 | SHARPLAN CO2 LASERS, MODEL NUMBERS 1050 AND 1075 | Oct 11, 1990 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K903079 | ENDOGUIDE (R), MICROGUIDE (TM), FLEXIGUIDE (TM) | Oct 04, 1990 | Substantially Equivalent | LUXAR CORP. |
| K902940 | CARDIOLASE YAG MODEL 4000 SURGICAL LASER SYSTEM | Oct 03, 1990 | Substantially Equivalent | TRIMEDYNE, INC. |
| K902939 | OPTILASE YAG MODEL 1000 SURGICAL LASER SYSTEM | Oct 03, 1990 | Substantially Equivalent | TRIMEDYNE, INC. |
| K900858 | CANDELA SPTL-1 LASER FOR TREATING BENIGN VASC. LES | Oct 03, 1990 | Substantially Equivalent | CANDELA LASER CORP. |
| K903027 | PEGASUS WITH ACCESSORIES | Oct 02, 1990 | Substantially Equivalent | PFIZER LASER SYSTEMS |
| K902990 | COHERENT HOLMIUM:YAG SURGICAL LASER | Oct 02, 1990 | Substantially Equivalent | COHERENT MEDICAL DIVISION |
| K902947 | PEGASUS W/ACCESSORIES FOR ARTHROSCOPIC APPLICATION | Oct 02, 1990 | Substantially Equivalent | PFIZER LASER SYSTEMS |
| K902946 | PEGASUS W/ACCESSORIES FOR GENERAL SURGERY | Oct 02, 1990 | Substantially Equivalent | PFIZER LASER SYSTEMS |
| K902133 | MODEL IS102S ND:YAG SURGICAL LASER SYSTEM | Oct 02, 1990 | Substantially Equivalent | NIIC U.S.A., INC. |
| K902534 | CENTAURI ERBIUM YITTRIUM ALUMINUM GARNET LASER | Sep 25, 1990 | Substantially Equivalent | PFIZER LASER SYSTEMS |
| K903288 | IRIS OCULIGHT SL DIODE LASER PHOTOCOAG/MODIFIED | Sep 24, 1990 | Substantially Equivalent | IRIDERM DIV. |
| K902871 | OPTILITE FIBEROPTIC DELIVERY SYSTEMS | Sep 24, 1990 | Substantially Equivalent | XINTEC CORPORATION |
| K903689 | COHERENT DIODE PHOTOCOAGULATOR | Sep 20, 1990 | Substantially Equivalent | LUMENIS, INC. |
| K901710 | OPTICA 120 ND:YAG SURGICAL LASER SYSTEM | Sep 20, 1990 | Substantially Equivalent | XINTEC CORPORATION |
| K903883 | VASCULASE(R) COPPER VAPOR LASER SYST, PIGMENT LES | Sep 19, 1990 | Substantially Equivalent | METATECH CORP. |
| K901127 | LASERCOMP MODEL STAR 10 FOR KNEE ARTHROSCOPY | Sep 10, 1990 | Substantially Equivalent | LASERCOMP |
| K900925 | NIDEK, INC. MODEL ADC-8000 DERM | Sep 10, 1990 | Substantially Equivalent | NIDEK, INC. |
| K900890 | NIDEK MODEL AKC-8000 OPHTHALMIC LASER PHOTOCOAGULA | Sep 10, 1990 | Substantially Equivalent | NIDEK, INC. |
| K903849 | MODEL RD-1200 RUBY LASER SYSTEM | Sep 05, 1990 | Substantially Equivalent | CHARLES L. ROSE AND CO., INC. |
| K901016 | LASER-SHIELD II(TM) | Aug 29, 1990 | Substantially Equivalent | XOMED, INC. |
| K901365 | LASER FORCEPS HANDPIECE | Aug 21, 1990 | Substantially Equivalent | LCA, INC. |
| K901205 | MODELS IR103,IR107,IR104,IR205 (ADD'L APPLICATION) | Aug 14, 1990 | Substantially Equivalent | NIIC U.S.A., INC. |
| K902470 | COHERENT XA30/SP AND XA50 SURGICAL LASERS | Jul 26, 1990 | Substantially Equivalent | LUMENIS, INC. |
| K902241 | SLT CONTACT LASER SYSTEMS (UROLOGY) | Jul 12, 1990 | Substantially Equivalent | SURGICAL LASER TECHNOLOGIES, INC. |
| K900837 | LPI YAG MODEL 1003 SURGICAL LASER SYSTEM | Jul 12, 1990 | Substantially Equivalent | LASER PHOTONICS, INC. |
| K902148 | MODELS 4000,4900,6000,8000,8900,LUXUS 60,100,1700 | Jul 10, 1990 | Substantially Equivalent | HERAEUS LASERSONICS, INC. |
| K902061 | MODELS 4000,4900,6000,8000,8900,LUXUS 60,100&1700 | Jul 10, 1990 | Substantially Equivalent | HERAEUS LASERSONICS, INC. |
| K902211 | SURGILASE YAG 100 SURGICAL LASER SYSTEM | Jun 29, 1990 | Substantially Equivalent | SURGILASE, INC. |
| K902063 | NIIC MODEL 15 CARBON-DIOXIDE SURGICAL LASER SYSTEM | Jun 29, 1990 | Substantially Equivalent | NIIC U.S.A., INC. |
| K902058 | ADD'L USE OF THE KTP/YAG SURGICAL LASER | Jun 29, 1990 | Substantially Equivalent | LASERSCOPE |
| K901786 | LASEGUIDE CAT # CLF-600D & CLF-1000D | Jun 27, 1990 | Substantially Equivalent | LASER PERIPHERALS LLC. |
| K901638 | MODIFIED COMBOLASER 5050 & NEW MODEL 5050 VER. 33 | Jun 27, 1990 | Substantially Equivalent | LASERMATIC, INC. |
| K901340 | MODEL MC 2100 ND:YAG SURGICAL LASER SYSTEM | Jun 26, 1990 | Substantially Equivalent | KLINGER MEDICAL |
| K901636 | DIAMOND ND:YAG OPHTHALMIC LASER | Jun 22, 1990 | Substantially Equivalent | BIOVISION, INC. |
| K902562 | REVISED LABELING FOR MODEL CL-0PE ND:YAG LASER | Jun 20, 1990 | Substantially Equivalent | LCA, INC. |
| K901481 | MODEL YC-1200/PHOTOCOAGULATOR OPHTHALMIC LASER | Jun 20, 1990 | Substantially Equivalent | NIDEK, INC. |
| K894241 | MODEL 20-CH W/ AR-10A/U OPTICAL ATTACHMENT | Jun 18, 1990 | Substantially Equivalent | DIRECTED ENERGY, INC. |
| K901204 | EXPANDED MARKETING OF MODELS IR104 & IR205 LASERS | Jun 05, 1990 | Substantially Equivalent | NIIC U.S.A., INC. |
| K901128 | LASERCOMP MODEL STAR 10 FOR ORAL,GYNECOLOGY SURG. | Jun 05, 1990 | Substantially Equivalent | LASERCOMP |
| K901943 | KTP/532 (TM) SURGICAL LASER | May 29, 1990 | Substantially Equivalent | LASERSCOPE |
| K896314 | ENDOSCOPIC USES OF THE ARGON LASER IN GENERAL SURG | May 10, 1990 | Substantially Equivalent | HGM MEDICAL LASER SYSTEMS, INC. |
| K900630 | MODELS 4000/4900/6000/8000/8900, LUXAS&1700 ND:YAG | May 04, 1990 | Substantially Equivalent | HERAEUS LASERSONICS, INC. |
| K901008 | HEXASCAN HANDPIECE | May 03, 1990 | Substantially Equivalent | LIHTAN TECHNOLOGIES, INC. |
| K900751 | HERAEUS LASERSONICS CO2 WAVEGUIDE DELIVERY SYSTEM | May 03, 1990 | Substantially Equivalent | HERAEUS LASERSONICS, INC. |
| K900539 | MODEL DLASE 300 ND:YAG LASER SYSTEM: INTRAORAL | May 03, 1990 | Substantially Equivalent | SUNRISE TECHNOLOGIES, INC. |
| K900570 | SURGILASE YAG 100 IN ORTHOPEDIC SURGERY | May 01, 1990 | Substantially Equivalent | SURGILASE, INC. |
| K900511 | I.C. MEDICAL ADJUSTABLE DIRECT COUPLER | May 01, 1990 | Substantially Equivalent | I.C. MEDICAL, INC. |
| K901227 | SURGILASE CO2 SURGICAL LASER SYSTEMS MODEL SL120 | Apr 26, 1990 | Substantially Equivalent | SURGILASE, INC. |
| K901211 | SURGILASE SL50 SURGICAL LASER SYSTEM | Apr 26, 1990 | Substantially Equivalent | SURGILASE, INC. |
| K900128 | CL-OPE CONTACT LASER SYSTEM | Apr 16, 1990 | Substantially Equivalent | LCA, INC. |
| K901541 | LASER LAPAROSCOPIC CHOLECYSTECTOMY | Apr 13, 1990 | Substantially Equivalent | SURGICAL LASER TECHNOLOGIES, INC. |
| K901021 | F300 SERIES CONTACT FIBER HANDPIECES | Apr 13, 1990 | Substantially Equivalent | HGM MEDICAL LASER SYSTEMS, INC. |
| K900345 | SHARPLAN ND:YAG LASERS FOR ENT AND NECK SURGERY | Apr 10, 1990 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K895945 | KTP/532 SURGICAL LASER SYSTEM W/KTP/YAG MODULE | Apr 09, 1990 | Substantially Equivalent | LASERSCOPE |
| K900253 | MODEL 20-CH CARBON DIOXIDE LASER W/ADD'L USES | Apr 05, 1990 | Substantially Equivalent | PFIZER LASER SYSTEMS |
| K900346 | SHARPLAN ND:YAG LASER LAPAROSCOPIC CHOLECYSTECTOMY | Apr 04, 1990 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K895347 | MICRORUPTOR III SYSTEM, CW ND: YAG LASER COMPONENT | Apr 02, 1990 | Substantially Equivalent | LASAG MEDICAL LASERS |
| K900592 | SHARPLAN MODEL 1055 SEALED CO2 SURGICAL LASER | Mar 27, 1990 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K900166 | NIDEK, INC. MODELS YC-1100 OPHTHALMIC LASERS | Mar 27, 1990 | Substantially Equivalent | NIDEK, INC. |
| K900463 | LASER DELIVERY SYSTEMS, FIBEROPTICS & CONTACT TIPS | Mar 22, 1990 | Substantially Equivalent | XIMED MEDICAL SYSTEMS |
| K900165 | NIDEK, INC. BIO-DC LASER DELIVERY SYSTEM | Mar 22, 1990 | Substantially Equivalent | NIDEK, INC. |
| K900076 | SHARPLAN FLEXIBLE CO2 SURGICAL LASER APPLICATOR | Mar 22, 1990 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K900153 | SHARPLAN ND:YAG DISPOSABLE FIBER DELIVERY SYSTEM | Mar 19, 1990 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K900066 | FLEXIGUIDE(TM) CO2 LASER HOLLOW FLEXIBLE FIBER | Mar 19, 1990 | Substantially Equivalent | LUXAR CORP. |
| K896939 | DISPOSABLE FIBER OPTIC DELIVERY SYSTEM FOR ND:YAG | Mar 08, 1990 | Substantially Equivalent | FIBER DELIVERY CONCEPTS, INC. |
| K900077 | SHARPLAN 1041 SEALED-OFF CO2 SURGICAL LASER SYSTEM | Mar 06, 1990 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K892912 | MODEL JM-1 CO2 LASER | Mar 06, 1990 | Substantially Equivalent | LASER, INC. |
| K897157 | OPTILASE YAG MODEL 1000 ACV SURGICAL LASER SYSTEM | Feb 22, 1990 | Substantially Equivalent | TRIMEDYNE, INC. |
| K895656 | ACCU-BEAM WAVEGUIDE | Feb 22, 1990 | Substantially Equivalent | TTI MEDICAL |
| K897099 | MODEL 2800 ND:YAG OPHTHALMIC LASER | Feb 16, 1990 | Substantially Equivalent | ALCON SURGICAL, INC. |
| K896762 | SHARPLAN ND:YAG LASER FOR ARTHROSCOPY/MENISCECTOMY | Feb 16, 1990 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K897040 | LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE (NEURO.) | Feb 13, 1990 | Substantially Equivalent | LUXAR CORP. |
| K896838 | BISTAT ELECTROSURGICAL UNIT 60-5400-001 | Feb 13, 1990 | Substantially Equivalent | ASPEN LABORATORIES, INC. |
| K900144 | QUARTZ FIBER CATHETERS AND SURGICAL TIPS | Feb 09, 1990 | Substantially Equivalent | PFIZER LASER SYSTEMS |
| K896517 | ILLUMINA MODELS 30, 40 & 55 CO2, MILLIWATT POWER | Feb 09, 1990 | Substantially Equivalent | HERAEUS LASERSONICS, INC. |
| K896478 | LUXAR MODEL LX-20 MINILASE CO2 LASER | Feb 08, 1990 | Substantially Equivalent | LUXAR CORP. |
| K896183 | KTP/532 SURGICAL LASER FOR PERCUTANEOUS DISKECTOMY | Feb 02, 1990 | Substantially Equivalent | LASERSCOPE |
| K896412 | GAS MIXTURES AS DEVICE COMPONENTS | Feb 01, 1990 | Substantially Equivalent | SPECTRA GASES, INC. |
| K896847 | SHARPLAN 1030 SEALED CO2 SURGICAL LASER SYSTEM | Jan 24, 1990 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K896988 | NIIC LASER SYSTEM | Jan 23, 1990 | Substantially Equivalent | NIIC U.S.A., INC. |
| K896049 | 35 WATT SURGICAL CARBON DIOXIDE LASER SYSTEM | Jan 11, 1990 | Substantially Equivalent | PFIZER LASER SYSTEMS |
| K896711 | LISTING PODIATRY AS INTENDED USE FOR ENDOGUIDE | Jan 09, 1990 | Substantially Equivalent | LUXAR CORP. |
| K896619 | LIST DERMATOLOGY/PLASTIC SURGERY AS USE ENDOGUIDE | Jan 09, 1990 | Substantially Equivalent | LUXAR CORP. |
| K896618 | LIST GENERAL SURGERY AS INTENDED USE FOR ENDOGUIDE | Jan 09, 1990 | Substantially Equivalent | LUXAR CORP. |
| K896617 | LISTING ENT AS INTENDED USE FOR ENDOGUIDE | Jan 09, 1990 | Substantially Equivalent | LUXAR CORP. |
| K896595 | LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE | Jan 09, 1990 | Substantially Equivalent | LUXAR CORP. |
| K895874 | OPTILASE YAG MODEL 1000 | Jan 03, 1990 | Substantially Equivalent | TRIMEDYNE, INC. |
| K895774 | GYN-PROBE | Jan 03, 1990 | Substantially Equivalent | TRIMEDYNE, INC. |
| K895918 | STERILE DISPOSABLE INFRATIP | Dec 14, 1989 | Substantially Equivalent | HERAEUS LASERSONICS, INC. |
| K895837 | MEDILASE SYSTEM 2010L LASER LITHOTRIPTOR | Dec 14, 1989 | Substantially Equivalent | MEDICAL LASER, INC. |
| K895581 | MODEL: IR205 ARTICULATED SURGICAL LASER | Dec 13, 1989 | Substantially Equivalent | NIIC U.S.A., INC. |
| K895663 | SITE 810E PHOTOCOAGULATOR AND ACCESSORIES | Dec 04, 1989 | Substantially Equivalent | SITE MICROSURGICAL SYSTEMS, INC. |
| K895518 | COHERENT HOLMIUM:YAG SURGICAL LASER | Nov 30, 1989 | Substantially Equivalent | LUMENIS, INC. |
| K895430 | HERAEUS LASERSONICS ND:YAG LASER, MODEL LUXUS 100 | Nov 28, 1989 | Substantially Equivalent | HERAEUS LASERSONICS, INC. |
| K895247 | MODEL IR103 SURGICAL LASER SYSTEM | Nov 16, 1989 | Substantially Equivalent | NIIC U.S.A., INC. |
| K895239 | MODEL IR107 50-WATT CARBON-DIOXIDE SURGICAL LASER | Nov 16, 1989 | Substantially Equivalent | NIIC U.S.A., INC. |
| K892359 | MODEL NUMBER: IR204 CO2 SURGICAL LASER SYSTEM | Nov 16, 1989 | Substantially Equivalent | NIIC U.S.A., INC. |
| K894471 | SURGIPROBES AND SURGISCALPES IN HEAD/NECK SURGERY | Nov 14, 1989 | Substantially Equivalent | SURGILASE, INC. |
| K895279 | LASERMATIC COMBOLASER MODEL 5050 | Nov 08, 1989 | Substantially Equivalent | LASERMATIC OY |
| K895786 | ENDOGUIDE PRODUCT LINE: EX0120, EX0300 AND EX0400 | Oct 27, 1989 | Substantially Equivalent | LUXAR CORP. |
| K895299 | LASERMEDIC 1200 RUBY LASER SYSTEM | Oct 24, 1989 | Substantially Equivalent | LASERMETRICS, INC. |
| K895559 | MODIFIED ENDOGUIDE | Oct 20, 1989 | Substantially Equivalent | LUXAR CORP. |
| K895348 | MICRORUPTOR III SYSTEM, CW ARGON LASER COMPONENT | Oct 20, 1989 | Substantially Equivalent | LASAG MEDICAL LASERS |
| K895263 | ILLUMINA MODEL 25, 40 AND 55 CO2 LASER SYSTEMS | Oct 20, 1989 | Substantially Equivalent | HERAEUS LASERSONICS, INC. |
| K895029 | SLT CONTACT LASER SYSTEMS FOR PHOTOCOAGULATION | Oct 16, 1989 | Substantially Equivalent | SURGICAL LASER TECHNOLOGIES, INC. |
| K895073 | POW-IR TIP | Oct 10, 1989 | Substantially Equivalent | LIVING TECHNOLOGY, INC. |
| K894977 | OPTILASE YAG MODEL 1000 SURGICAL LASER SYSTEM | Oct 10, 1989 | Substantially Equivalent | TRIMEDYNE, INC. |
| K894591 | GYNEGUIDE | Oct 10, 1989 | Substantially Equivalent | MARLO SURGICAL TECHNOLOGY |
| K895746 | SHARPLAN MODEL 710 MICROSPOT | Oct 05, 1989 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K894841 | IRIS OCULIGHT(TM) SL | Oct 05, 1989 | Substantially Equivalent | IRIDERM DIV. |
| K894709 | NIDEK MODEL ADC-8000 | Oct 04, 1989 | Substantially Equivalent | NIDEK, INC. |
| K894962 | CO2 LASER BRONCHOSCOPE COUPLER | Sep 28, 1989 | Substantially Equivalent | CUDA PRODUCTS CO. |
| K895042 | SHARPLAN CO2 LASERS FOR ARTHROSCOPIC SURGERY | Sep 27, 1989 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K895143 | COHERENT XA-50, X30/CW, XA30/SP SURGICAL LASERS | Sep 25, 1989 | Substantially Equivalent | LUMENIS, INC. |
| K895093 | SLT CONTACT LASER SYSTEMS | Sep 18, 1989 | Substantially Equivalent | SURGICAL LASER TECHNOLOGIES, INC. |
| K894186 | SURGIFLEX LASER CONTACT TIPS | Sep 12, 1989 | Substantially Equivalent | CABOT MEDICAL CORP. |
| K894164 | MODELS 4000,4900,6000,8000,8900 ND YAG 1700ND | Aug 29, 1989 | Substantially Equivalent | HERAEUS LASERSONICS, INC. |
| K894074 | CO2 SURGICAL LASER SYSTEM | Aug 24, 1989 | Substantially Equivalent | NIIC U.S.A., INC. |
| K894211 | SHARPLAN SERIES 2900 SYNTHETIC CONTACT TIPS | Aug 10, 1989 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K894210 | SHARPLAN SERIES 2900 SYNTHETIC CONTACT TIPS | Aug 10, 1989 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K894066 | SHARPLAN CO2 LAPAROSCOPIC PROBE MODEL 792 TO 792BX | Aug 10, 1989 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K893956 | EAGLE LASER, SURGICAL, NEODYMIUM DOPED YTTRIUM | Aug 10, 1989 | Substantially Equivalent | LIVING TECHNOLOGY, INC. |
| K893832 | CO2 LASER SYSTEMS & ARTHROGUIDE CO2 LASER FIBER | Aug 09, 1989 | Substantially Equivalent | HERAEUS LASERSONICS, INC. |
| K894396 | SURGILASE 25, 40, 45, 55, 60, 80, 100 LASER | Aug 07, 1989 | Substantially Equivalent | SURGILASE, INC. |
| K894393 | OPMILAS CO2-L | Jul 27, 1989 | Substantially Equivalent | CARL ZEISS, INC. |
| K893642 | MODIFIED ENDOGUIDE | Jul 14, 1989 | Substantially Equivalent | LUXAR CORP. |
| K892933 | INFRALASE-LASERGUIDE DELIVERY SYSTEM | Jun 22, 1989 | Substantially Equivalent | XIMED MEDICAL SYSTEMS |
| K893701 | SLT CONTACT LASER SYSTEM | Jun 21, 1989 | Substantially Equivalent | SURGICAL LASER TECHNOLOGIES, INC. |
| K893206 | SHARPLAN 1075 CO2 LASER | Jun 21, 1989 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K892516 | CANDELA PLDL-1 PULSED DYE LASER | Jun 15, 1989 | Substantially Equivalent | CANDELA LASER CORP. |
| K893529 | COMBOLASER MODEL 5050 | Jun 08, 1989 | Substantially Equivalent | LASERMATIC, INC. |
| K885257 | EAGLE - NEODYUMIUM DOPED YTTRIUM ALUMINUM GARNET | Jun 05, 1989 | Substantially Equivalent | LIVING TECHNOLOGY, INC. |
| K885170 | LASERCOMP MODEL: 10 STAR 10 | Jun 05, 1989 | Substantially Equivalent | LASER-WEST |
| K885060 | PEGASUS | Jun 02, 1989 | Substantially Equivalent | PFIZER LASER SYSTEMS |
| K891909 | LIGHT-TOUCH/GS 905250 ND:YAG LASER MICRO PRO ENDOS | May 26, 1989 | Substantially Equivalent | LIFESTREAM INT'L, INC. |
| K893013 | LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE | May 23, 1989 | Substantially Equivalent | LUXAR MEDICAL LASER INSTRUMENTS |
| K891130 | LIGHT-TOUCH LAPAROSCOPIC MODEL 905200 FIBEROPTIC | May 23, 1989 | Substantially Equivalent | LIFESTREAM INT'L, INC. |
| K892211 | HERAEUS LASERSONIC INC. STERILE DISPOSABLE FIBERS | May 19, 1989 | Substantially Equivalent | HERAEUS LASERSONICS, INC. |
| K890922 | ACCU-BEAM YAG FIBER | May 15, 1989 | Substantially Equivalent | TTI MEDICAL |
| K892346 | SLT CONTACT LASER SYSTEMS (GYNECOLOGY) | May 01, 1989 | Substantially Equivalent | SURGICAL LASER TECHNOLOGIES, INC. |
| K892345 | SLT CONTACT LASER SYSTEMS (NEUROSURGERY) | Apr 27, 1989 | Substantially Equivalent | SURGICAL LASER TECHNOLOGIES, INC. |
| K890775 | INFRALASE - LASERGUIDE DELIVERY SYSTEM | Apr 21, 1989 | Substantially Equivalent | XIMED MEDICAL SYSTEMS |
| K890287 | SHARPLAN MODEL 1050 SEALED-OFF CO2 SURGICAL LASER | Apr 12, 1989 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K891461 | SURGILASE YAG 100 SURGICAL ND:YAG LASER/GEN SURG | Apr 06, 1989 | Substantially Equivalent | SURGILASE, INC. |
| K890322 | SLT CONTACT LASER SYSTEM (ENT, HEAD & NECK SURG.) | Apr 05, 1989 | Substantially Equivalent | SURGICAL LASER TECHNOLOGIES, INC. |
| K890321 | SLT CONTACT LASER SYSTEM (ORTHOPEDICS) | Apr 05, 1989 | Substantially Equivalent | SURGICAL LASER TECHNOLOGIES, INC. |
| K890286 | SHARPLAN MODEL 750 REMOTE CONTROL UNIT (RCU) | Apr 05, 1989 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K890865 | HEXASCAN SCANNER HANDPIECE | Mar 24, 1989 | Substantially Equivalent | METATECH CORP. |
| K891126 | MICROLASE CO2 LASER MICROMANIPULATOR | Mar 17, 1989 | Substantially Equivalent | XIMED MEDICAL SYSTEMS |
| K891088 | MODIFIED LABELING PACKAGING SHARPLAN 2100 STERILE | Mar 17, 1989 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K891016 | SHARPLAN MODEL 2106 | Mar 13, 1989 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K890040 | MODIFIED LABELING & PACKAGING OF SHARPLAN 2100 | Feb 14, 1989 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K890279 | MODIFIED MODEL 1000 OPTILASE(TM) ND:YAG LASER | Feb 07, 1989 | Substantially Equivalent | TRIMEDYNE, INC. |
| K890059 | SHARPLAN COMBINED CO2/ND:YAG LASER MICRO. #749 | Feb 06, 1989 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K885291 | MODEL 20-CH CARBON DIOXIDE LASER W/ACCESSORIES | Feb 03, 1989 | Substantially Equivalent | PFIZER LASER SYSTEMS |
| K890174 | SLT CLMD CONTACT LASER SYSTEM (ADDIT. INDICATION) | Jan 26, 1989 | Substantially Equivalent | SURGICAL LASER TECHNOLOGIES, INC. |
| K884182 | SURGILASE YAG 100 SURGIPROBES & SURGISCALPEL | Jan 24, 1989 | Substantially Equivalent | SURGILASE, INC. |
| K883379 | MODELS 4000/4900/6000/8000/8900 ND:YAG & 1700 CO2 | Jan 24, 1989 | Substantially Equivalent | HERAEUS LASERSONICS, INC. |
| K885181 | (HLI) CARBON DIOXIDE SYSTEMS W/INFRAGUIDE CO2 | Jan 10, 1989 | Substantially Equivalent | HERAEUS LASERSONICS, INC. |
| K884682 | LIVING TECHNOLOGY LASER CONTACT TIPS | Jan 05, 1989 | Substantially Equivalent | LIVING TECHNOLOGY, INC. |
| K884459 | LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE | Dec 19, 1988 | Substantially Equivalent | LUXAR CORP. |
| K883488 | CO2 LASER SYSTEM & ARTHOGUIDE CO2 LASER FIBER DEL. | Dec 19, 1988 | Substantially Equivalent | HERAEUS LASERSONICS, INC. |
| K884994 | SHARPLAN-MEDILAS 4060N YAG LASER & SERIES 2900 TIP | Dec 15, 1988 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K884456 | STERILE DISPOSABLE ENDOCULAR PROBE | Dec 09, 1988 | Substantially Equivalent | BIOPHYSIC MEDICAL, INC. |
| K884431 | HEXASCAN HANDPIECE FOR ARGON/DYE LASER | Dec 02, 1988 | Substantially Equivalent | CALIFORNIA LABORATORIES, INC. |
| K884029 | KTP/532 SURGICAL LASER | Nov 25, 1988 | Substantially Equivalent | LASERSCOPE |
| K883738 | CARBON DIOXIDE LASER SYSTEM MODEL 20-CX W/ATTACH. | Nov 15, 1988 | Substantially Equivalent | DIRECTED ENERGY, INC. |
| K884060 | MEDITEC QL-15 ND:YAG LASER | Nov 04, 1988 | Substantially Equivalent | STORZ OPHTHALMICS, INC. |
| K883541 | METALASER VASCULASE | Nov 04, 1988 | Substantially Equivalent | METATECH CORP. |
| K884204 | COHERENT EXCELITE CO2 AIR FIBER | Nov 03, 1988 | Substantially Equivalent | COHERENT MEDICAL LASERS |
| K882952 | CO2 SURGICAL LASER SYSTEM MODEL #IR106 | Nov 02, 1988 | Substantially Equivalent | NIIC U.S.A., INC. |
| K882951 | CO2 SURGICAL LASER SYSTEM MODEL #IR105 | Nov 02, 1988 | Substantially Equivalent | NIIC U.S.A., INC. |
| K884313 | MODEL SL45 SURGILASE CO2 SURGICAL LASER SYSTEMS | Oct 27, 1988 | Substantially Equivalent | SURGILASE, INC. |
| K884311 | MODEL SL60 SURGILASE CO2 SURGICAL LASER SYSTEMS | Oct 27, 1988 | Substantially Equivalent | SURGILASE, INC. |
| K883642 | CODMAN NEUROLASE LASER SYSTEM | Oct 20, 1988 | Substantially Equivalent | I.L. MED, INC. |
| K884092 | SURGILASE CO2 SURGICAL LASER SYSTEM MODEL SL80 | Oct 13, 1988 | Substantially Equivalent | SURGILASE, INC. |
| K883089 | 4000/4900/6000/8000/8900 ND:YAG/1700 ND:YAG C02 | Sep 28, 1988 | Substantially Equivalent | HERAEUS LASERSONICS, INC. |
| K883563 | SHARPLAN 2100 ND:YAG LASER, SERIES 2900 SYN. TIPS | Sep 27, 1988 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K882926 | MODEL AU-1 ACCESSORY UNIT | Sep 09, 1988 | Substantially Equivalent | DIRECTED ENERGY, INC. |
| K882734 | KTP/YAG(TM) SURGICAL LASER | Sep 09, 1988 | Substantially Equivalent | LASERSCOPE |
| K882365 | HERAEUS LASERSONICS ND:YAG LASER, MODEL 4900 | Sep 02, 1988 | Substantially Equivalent | HERAEUS LASERSONICS, INC. |
| K882738 | L.P.I. LASER DELIVERY SYSTEM | Aug 30, 1988 | Substantially Equivalent | LASER PHOTONICS, INC. |
| K882772 | LQ1106 OPHTHALMIC YAG LASER | Aug 26, 1988 | Substantially Equivalent | KEELER INSTRUMENTS, INC. |
| K882942 | LASER MIXTURE | Aug 23, 1988 | Substantially Equivalent | SWISCO, INC. |
| K882212 | SLT CONTACT LASER SYSTEM | Aug 17, 1988 | Substantially Equivalent | SURGICAL LASER TECHNOLOGIES, INC. |
| K882516 | THREE-COMPONENT MEDICAL LASER GAS MIXTURES | Aug 03, 1988 | Substantially Equivalent | MATHESON GAS PRODUCTS, INC. |
| K882208 | MEDIBLEND (TM) MEDICAL LASER GAS MIXTURES | Aug 03, 1988 | Substantially Equivalent | LINDE DIV. UNION CARBIDE CORP. |
| K880816 | MODEL 130YZ CO2-YAG SURGICAL LASER SYSTEM | Aug 01, 1988 | Substantially Equivalent | NIIC U.S.A., INC. |
| K881940 | MODEL 20 KY KRYPTON YELLOW LASER | Jul 20, 1988 | Substantially Equivalent | HGM MEDICAL LASER SYSTEMS, INC. |
| K881619 | 4000/4900/6000/8000/8900 YAG, & 1700 YAG/CO2 LASER | Jul 08, 1988 | Substantially Equivalent | HERAEUS LASERSONICS, INC. |
| K871512 | SL-100 ND:YAG LASER FOR GYNECOLOGY USE | Jul 08, 1988 | Substantially Equivalent | MEDICAL ENERGY, INC. |
| K882243 | SPTL-1 PULSED DYE LASER | Jul 05, 1988 | Substantially Equivalent | CANDELA LASER CORP. |
| K881788 | KTP/532(TM) SURGICAL LASER | Jun 27, 1988 | Substantially Equivalent | LASERSCOPE |
| K882160 | COHERENT SYSTEM 920 ARGON/DYE PHOTOCOAGULATOR | Jun 22, 1988 | Substantially Equivalent | COHERENT MEDICAL LASERS |
| K882037 | SHARPLAN MEDILAS 4060 N | Jun 20, 1988 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K880061 | FULLER IRFLEX FIBER OPTIC SURGICAL LASER SYSTEM | Jun 20, 1988 | Substantially Equivalent | ABBOTT LABORATORIES |
| K881953 | SHARPLAN MODELS 719/719SR/719SL COLPOSLAD COS SU | Jun 03, 1988 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K881952 | SHARPLAN MODELS 719-O COLPOSLAD CO2 SU MICROMANI. | Jun 03, 1988 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K881588 | MODEL MD-25 LASER FOR SURGICAL USE | Jun 03, 1988 | Substantially Equivalent | LASER ENGINEERING, INC. |
| K881587 | MODEL MD-25 CO2 LASER FOR PODIATRY APPLICATIONS | Jun 03, 1988 | Substantially Equivalent | LASER ENGINEERING, INC. |
| K881586 | MODEL MD-45 CO2 LASER FOR ENT APPLICATIONS | Jun 03, 1988 | Substantially Equivalent | LASER ENGINEERING, INC. |
| K881585 | MODEL MD-25 CO2 LASER FOR NEUROSURGERY USE | Jun 03, 1988 | Substantially Equivalent | LASER ENGINEERING, INC. |
| K881584 | MODEL MD-45 CO2 LASER FOR NEUROSURGERY USE | Jun 03, 1988 | Substantially Equivalent | LASER ENGINEERING, INC. |
| K881583 | MODEL MD-25 CO2 LASER FOR EAR, NOSE & THROAT | Jun 03, 1988 | Substantially Equivalent | LASER ENGINEERING, INC. |
| K881582 | MODEL MD-45 CO2 LASER FOR DERMATOLOGY/PODIATRY USE | Jun 03, 1988 | Substantially Equivalent | LASER ENGINEERING, INC. |
| K881581 | MODEL MD-45 CO2 LASER FOR OB-GYN & UROLOGICAL USE | Jun 03, 1988 | Substantially Equivalent | LASER ENGINEERING, INC. |
| K881580 | MODEL MD-25 CO2 LASER FOR DERMA./PLASTIC SURGERY | Jun 03, 1988 | Substantially Equivalent | LASER ENGINEERING, INC. |
| K882180 | MODIFIED SHARPLAN MODEL 1020 CO2 LASER | Jun 02, 1988 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K881870 | SHARPLAN ND:YAG SURGICAL HAND APPLICATORS | May 24, 1988 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K881824 | LASER MICROMANIPULATOR | May 24, 1988 | Substantially Equivalent | PFIZER LASER SYSTEMS |
| K881887 | SHARPLAN 719Y MICROSLAD(TM) | May 13, 1988 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K881848 | MODIFIED MODEL 2100 ND:YAG LASER | May 11, 1988 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K880908 | MODEL PC ARGON LASER | May 03, 1988 | Substantially Equivalent | HGM, INC. |
| K880809 | ILLUMINA MODEL 55 CO2 LASER FOR GENERAL/PLASTIC SU | Apr 18, 1988 | Substantially Equivalent | COOPER LASERSONICS, INC. |
| K880808 | ILLUMINA MODEL 40 CO2 LASER FOR GENERAL/PLASTIC SU | Apr 18, 1988 | Substantially Equivalent | COOPER LASERSONICS, INC. |
| K880807 | ILLUMINA MODEL 25 CO2 LASER FOR GENERAL/PLASTIC SU | Apr 18, 1988 | Substantially Equivalent | COOPER LASERSONICS, INC. |
| K875338 | CHRYS(TM) MODEL MED-MAX | Apr 13, 1988 | Substantially Equivalent | CALIFORNIA LABORATORIES, INC. |
| K880603 | COHERENT XA-40 CO2 SURGICAL LASER | Mar 11, 1988 | Substantially Equivalent | COHERENT MEDICAL GROUP |
| K880216 | MODEL 20C W/AN AR-10A/U & RL-20A/U FOR ARTHROSCOP. | Mar 04, 1988 | Substantially Equivalent | DIRECTED ENERGY, INC. |
| K875115 | INFRAGUIDE(TM) | Feb 26, 1988 | Substantially Equivalent | COOPER LASERSONICS, INC. |
| K874948 | SUN MEDICAL SMOKE EVACUATOR SYSTEM | Feb 18, 1988 | Substantially Equivalent | SUN MEDICAL, INC. |
| K874811 | MODEL 5202 MICROMANIPULATOR | Feb 05, 1988 | Substantially Equivalent | COHERENT MEDICAL GROUP |
| K874648 | COHERENT XA-30/SP CO2 SURGICAL LASER | Feb 04, 1988 | Substantially Equivalent | COHERENT MEDICAL GROUP |
| K873790 | MODELS 4000/6000/8000/8900 LASER FOR DERMA/SURGERY | Jan 22, 1988 | Substantially Equivalent | COOPER LASERSONICS, INC. |
| K871933 | MODEL 5050 SURGILASER FOR NEUROSURGERY USE | Jan 22, 1988 | Substantially Equivalent | LASERMATIC, INC. |
| K873443 | ULTRASPOT MICROMANIPULATOR | Jan 06, 1988 | Substantially Equivalent | COOPER LASERSONICS, INC. |
| K873760 | SUPERPULSE AMBULASE (XAM-SP) CO2 SURGICAL LASER | Nov 27, 1987 | Substantially Equivalent for Some Indications | COHERENT MEDICAL GROUP |
| K873246 | MODEL 5001 MICROMANIPULATOR FOR USE W/TF-25 CO2 | Nov 10, 1987 | Substantially Equivalent | COHERENT MEDICAL GROUP |
| K873664 | LIGHT-SPOT FIBEROPTIC LASER HANDPIECE | Nov 06, 1987 | Substantially Equivalent | LASERGUIDE |
| K873571 | LIGHT-TOUCH FIBEROPTIC MICROCONTACT PROBE | Nov 06, 1987 | Substantially Equivalent | LASERGUIDE |
| K873963 | COHERENT XA-30 CO2 SURGICAL LASER | Oct 19, 1987 | Substantially Equivalent | COHERENT MEDICAL GROUP |
| K873773 | ENDOCOAGULATOR MODELS 8 AND 20 ARGON LASER | Oct 13, 1987 | Substantially Equivalent | HGM, INC. |
| K872179 | CODMAN NEUROLASE LASER SYSTEM | Oct 07, 1987 | Substantially Equivalent | Codman & Shurtleff, Inc. |
| K872578 | MDS-90 ARGON DYE LASER FOR DERMATOLOGY | Oct 01, 1987 | Substantially Equivalent | MEDITEC OF AMERICA |
| K872711 | MODEL 20-C W/AR-10A/U ATTACH. FOR ARTHRO. SURGERY | Sep 28, 1987 | Substantially Equivalent | DIRECTED ENERGY, INC. |
| K872589 | ACCESSORY TO LASER EQUIPMENT - SMOKE EVACUATOR | Sep 11, 1987 | Substantially Equivalent | CLASS, INC. |
| K871619 | LPM-1 (LASER POWER METER) | Jul 28, 1987 | Substantially Equivalent | BIO-TEK INSTRUMENTS, INC. |
| K871206 | LUMENX MODEL GAT-577 PHOTOCOAGU. PULSED DYE LASER | Jul 22, 1987 | Substantially Equivalent | PHASE-R CORP. |
| K871334 | LASE SYSTEM II | Jun 01, 1987 | Substantially Equivalent | LASE, INC. |
| K870971 | MODEL 20-C WITH AN SA-20B/U OPTICAL ATTACHMENT | May 26, 1987 | Substantially Equivalent | DIRECTED ENERGY, INC. |
| K870970 | MODEL 10-C WITH AN SA-10B/U OPTICAL ATTACHMENT | May 26, 1987 | Substantially Equivalent | DIRECTED ENERGY, INC. |
| K870838 | MODEL 10-C W/ SA-10A/U OPTICAL ATTACHMENT/SURG USE | May 26, 1987 | Substantially Equivalent | DIRECTED ENERGY, INC. |
| K870837 | MODEL 20-C W/SA-20A/U OPTICAL ATTACHMENT/SURG USE | May 26, 1987 | Substantially Equivalent | DIRECTED ENERGY, INC. |
| K870161 | MODEL 5000 MICROMANIPULATOR MICRO CO2 LASER SYSTEM | Apr 14, 1987 | Substantially Equivalent for Some Indications | COHERENT MEDICAL GROUP |
| K870517 | 0.1MM, 0.25MM, 0.5MM, ZOOM DERMATOLOGIC HANDPIECE | Apr 10, 1987 | Substantially Equivalent for Some Indications | COHERENT MEDICAL GROUP |
| K864887 | ADVANCED HAND HELD CO2 LASER MODEL HH-550 FOR SU | Apr 10, 1987 | Substantially Equivalent for Some Indications | BIO QUANTUM TECHNOLOGIES, INC. |
| K864563 | MODEL LS 840, CO2 LASER | Apr 09, 1987 | Substantially Equivalent for Some Indications | COOPER LASERSONICS, INC. |
| K864562 | MODEL LS 860, CO2 LASER | Apr 09, 1987 | Substantially Equivalent for Some Indications | COOPER LASERSONICS, INC. |
| K862514 | OMNIPLUS FREQ DOUBLE ND:YAG PHOTOSURG SYS/NEURO | Feb 04, 1987 | Substantially Equivalent | LASERSCOPE |
| K863086 | SAPPHIRE LASER BLADES (LASER BLADES) ND: YAG | Dec 04, 1986 | Substantially Equivalent | COOPER LASERSONICS, INC. |
| K861179 | CANDELA MODEL SPT-1, PULSED DYE LASER | Nov 20, 1986 | Substantially Equivalent | CANDELA CORP. |
| K862815 | LASER SURGICAL ROD | Nov 17, 1986 | Substantially Equivalent | LIFESTREAM INT'L, INC. |
| K861044 | MODEL 2100 ND:YAG SURGICAL LASER NEUROSURGICAL IND | Oct 28, 1986 | Substantially Equivalent | SHARPLAN INDUSTRIES, INC. |
| K863183 | ND:YAG LASER, MODEL 6000 FOR NEUROSURGERY | Oct 24, 1986 | Substantially Equivalent | COOPER LASERSONICS, INC. |
| K862864 | MODEL 20-C W/FL-20A/U FOR SURGERY & DERMATOLOGY | Oct 24, 1986 | Substantially Equivalent | DIRECTED ENERGY, INC. |
| K862863 | MODEL 10-C W/LC-10A/U FOR OPHTHALMIC & ORBITAL USE | Oct 24, 1986 | Substantially Equivalent | DIRECTED ENERGY, INC. |
| K862408 | MODEL 8-B CO2 LASER FOR OPTHALMIC & ORBITAL SURG | Oct 24, 1986 | Substantially Equivalent | DIRECTED ENERGY, INC. |
| K861688 | XANAR CO2 SURGICAL LASER SYSTEM MODEL XAP-15 | Oct 03, 1986 | Substantially Equivalent | XANAR, INC. |
| K862422 | MODEL 20-B CO2 LASER FOR GENERAL & PLASTIC SURGERY | Oct 02, 1986 | Substantially Equivalent | DIRECTED ENERGY, INC. |
| K860831 | MODEL LS-870 CO2 SURGICAL LASER SYSTEM (MODIFIED) | Oct 02, 1986 | Substantially Equivalent | COOPER LASERSONICS, INC. |
| K862862 | MODEL 10-C W/FL-10A/U FOR SURGERY AND DERMATOLOGY | Sep 19, 1986 | Substantially Equivalent | DIRECTED ENERGY, INC. |
| K863433 | MODEL 8900 ND:YAG LASER | Sep 17, 1986 | Substantially Equivalent | COOPER LASERSONICS, INC. |
| K862423 | MODEL 8-B CO2 LASER FOR GENERAL & PLASTIC SURGERY | Sep 15, 1986 | Substantially Equivalent | DIRECTED ENERGY, INC. |
| K862472 | QUARTZ RODS TITANIUM RODS | Sep 12, 1986 | Substantially Equivalent | QUALI-MED, INC. |
| K853117 | COOPER LASER SONICS ND: YAG LASER, MODEL 8008 | Aug 12, 1986 | Substantially Equivalent | COOPER LASERSONICS, INC. |
| K860083 | DERMASCAN LASER SURGICAL HANDPIECE | Aug 07, 1986 | Substantially Equivalent | MEDICAL LASER RESEARCH & DEVELOPMENT CORP. |
| K860974 | MODEL 545-45 LASER FOR DERMA., POD., SURGICAL | Jul 07, 1986 | Substantially Equivalent | BRITT CORP., INC. |
| K854473 | PORTALASE 300 CARBON DIOXIDE SURG LASER NEUROLOGIC | Jun 20, 1986 | Substantially Equivalent | MINNESOTA LASER CORP. |
| K854468 | PORTALASE 200 CARBON DIOXIDE SURG LASER NEUROLOGIC | Jun 20, 1986 | Substantially Equivalent | MINNESOTA LASER CORP. |
| K853900 | ENDO-LASE CD40 FOR NEUROSURGERY | Jun 18, 1986 | Substantially Equivalent | ENDO LASE, INC. |
| K855210 | SURGICAL CARBON DIOXIDE LASER SYS. #20B ULTRALIGHT | May 02, 1986 | Substantially Equivalent | DIRECTED ENERGY, INC. |
| K854998 | SURGICAL CO2 LASER SYSTEM #20/OPTICAL FOR ARTHROSC | May 02, 1986 | Substantially Equivalent | DIRECTED ENERGY, INC. |
| K853878 | ENDO-LASE CD-100 CO2 LASER FOR NEUROSURGERY | May 02, 1986 | Substantially Equivalent | ENDO LASE, INC. |
| K860087 | SHARPLAN MODEL 1020 CO2 SURGICAL LASER SYSTEM | Apr 24, 1986 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K860273 | MODEL 525 - 25 WATT CO2 MEDICAL LASER/PODIATRY | Apr 23, 1986 | Substantially Equivalent | BRITT CORP., INC. |
| K852436 | AMBULASE | Apr 18, 1986 | Substantially Equivalent | XANAR, INC. |
| K860278 | MODEL 525-25 WATT CO2 LASER FOR DERMA/PLASTIC | Apr 15, 1986 | Substantially Equivalent | BRITT CORP., INC. |
| K854833 | MDS-83 IN DERMATOLOGICAL/PLASTIC SURGERY APPLICATI | Apr 04, 1986 | Substantially Equivalent | MEDITEC, INC. |
| K854386 | MODEL 20 PREVIOUSLY HAND-HELD CO2 LASER SYSTEM | Mar 28, 1986 | Substantially Equivalent | DIRECTED ENERGY, INC. |
| K855246 | AURORA M MEDICAL DYE LASER | Mar 21, 1986 | Substantially Equivalent | COOPER LASERSONICS, INC. |
| K853901 | ENDO-LASE CD 40 FOR DERMATOLOGY | Feb 19, 1986 | Substantially Equivalent | ENDO LASE, INC. |
| K853877 | ENDO-LASE CD-100 CO2 LASER FOR DERMATOLOGY | Feb 19, 1986 | Substantially Equivalent | ENDO LASE, INC. |
| K854472 | PORTALASE 300 CARBON DIOXIDE SURG LASER DERMATOLOG | Feb 11, 1986 | Substantially Equivalent | MINNESOTA LASER CORP. |
| K854469 | PORTALASE 200 CARBON DIOXIDE SURG LASER DERMATOLOG | Feb 11, 1986 | Substantially Equivalent | MINNESOTA LASER CORP. |
| K854399 | MODEL 20-B CO2 LASER SYSTEM | Feb 07, 1986 | Substantially Equivalent | DIRECTED ENERGY, INC. |
| K854398 | MODEL CO2 LASER SYSTEM 8B | Feb 07, 1986 | Substantially Equivalent | DIRECTED ENERGY, INC. |
| K854387 | MODEL 8A PREVIOUSLY MINI HALO CO2 LASER SYSTEM | Feb 07, 1986 | Substantially Equivalent | DIRECTED ENERGY, INC. |
| K854134 | FIBEROPTIC COLLIMATING HANDPIECE | Feb 07, 1986 | Substantially Equivalent | DAWN LASER TECHNOLOGY, INC. |
| K853627 | CODMAN LASER RODS | Feb 07, 1986 | Substantially Equivalent | Codman & Shurtleff, Inc. |
| K853626 | CODMAN LASER BACKSTOP | Feb 07, 1986 | Substantially Equivalent | Codman & Shurtleff, Inc. |
| K853620 | MODEL XA-50 - CO2 SURGICAL LASER | Jan 24, 1986 | Substantially Equivalent | XANAR, INC. |
| K852470 | SURGILASE 40S | Nov 13, 1985 | Substantially Equivalent | SURGILASE, INC. |
| K853904 | ENDO-LASE CD40 FOR UROLOGY | Oct 25, 1985 | Substantially Equivalent | ENDO LASE, INC. |
| K853874 | ENDO-LASE CD-100 CO2 LASER FOR EXTERNAL GENITALIA- | Oct 25, 1985 | Substantially Equivalent | ENDO LASE, INC. |
| K844178 | MODEL TT25RF | Oct 18, 1985 | Substantially Equivalent | INFRAMED, INC. |
| K852860 | MODEL 920 ARGON/DYE LASER-FOR DERMATOLOGICAL/USE | Oct 07, 1985 | Substantially Equivalent | COHERENT MEDICAL GROUP |
| K851405 | TRIMEDYNE MEDICAL ARGON LASER SYSTEM MODEL 700 | Oct 07, 1985 | Substantially Equivalent | TRIMEDYNE, INC. |
| K853319 | MINI-HALO(HAND-HELD) CO2 LASER SYSTEM | Sep 19, 1985 | Substantially Equivalent | DIRECTED ENERGY, INC. |
| K852696 | FOR USE IN GENERAL & PLASTIC SURGERY & DERMATOLOGY | Sep 19, 1985 | Substantially Equivalent | MINNESOTA LASER CORP. |
| K852190 | MODEL 451 CO2 SURGICAL LASER | Aug 23, 1985 | Substantially Equivalent | COHERENT MEDICAL GROUP |
| K852122 | MEDILASER MIC MODEL MEL-445C, 15W | Aug 20, 1985 | Substantially Equivalent | MOCHIDA PHARMACEUTICAL CO., LTD. |
| K852121 | MEDILASER MIC MODEL MEL 440-C;30W | Aug 20, 1985 | Substantially Equivalent | MOCHIDA PHARMACEUTICAL CO., LTD. |
| K850818 | CO 2 SURGICAL LASER SYSTEM NA-120 | Aug 15, 1985 | Substantially Equivalent | XANAR, INC. |
| K850805 | CO 2 SURGICAL LASER SYSTEM MODEL NA-40 | Aug 15, 1985 | Substantially Equivalent | XANAR, INC. |
| K850804 | CO 2 SURGICAL LASER SYSTEM NA-30 | Aug 15, 1985 | Substantially Equivalent | XANAR, INC. |
| K851000 | COOPER LASERSONICS 880 CO2/ND:YAG MEDICAL LASER SY | Aug 14, 1985 | Substantially Equivalent | COOPER LASERSONICS, INC. |
| K850633 | SHARPLAN MODEL 1060 CO/2 SURGICAL LASER | Aug 07, 1985 | Substantially Equivalent | LASER INDUSTRIES LTD. |
| K850628 | SHARPLAN 1040 CO/2 SURGICAL LASER | Aug 07, 1985 | Substantially Equivalent | LASER INDUSTRIES LTD. |
| K852252 | 870 SURGICAL SYS CONTROL PULSE MODIFICATION | Jun 27, 1985 | Substantially Equivalent | COOPER LASERSONICS, INC. |
| K850018 | LASERSCOPE OMNIPLUS PHOTOSURGICAL SYS ND:YAG | Jun 18, 1985 | Substantially Equivalent | LASERSCOPE |
| K851527 | UTILIZATION OF ND:YAG LASER FOR TREATMENT RECTAL P | May 17, 1985 | Substantially Equivalent | ENDO LASE, INC. |
| K844644 | SURGICAL LASER MICRO-TIPS | May 10, 1985 | Substantially Equivalent | SURGICAL LASER TECHNOLOGIES, INC. |
| K844643 | S.L.T. LASER DELIVERY HANDLES W/SURGICAL RODS | May 10, 1985 | Substantially Equivalent | SURGICAL LASER TECHNOLOGIES, INC. |
| K843915 | MINI-HALO CO2 LASER SYSTEM | May 10, 1985 | Substantially Equivalent | COOPERVISION, INC. |
| K850779 | MODEL 4000 ND:YAG LASER FOR GENITOURINARY APPLICAT | Apr 02, 1985 | Substantially Equivalent | COOPER LASERSONICS, INC. |
| K850985 | FLEXUS 2 CO2 SURGICAL LASER SYSTEM | Mar 25, 1985 | Substantially Equivalent | INTL. SOLARIUM MANUFACTURER, INC. |
| K841781 | MODEL 305AA PORTABLE LASER | Nov 07, 1984 | Substantially Equivalent | LASER SPECTRUM, INC. |
| K842703 | ND-YAG LASER 8000 NEUROSURGERY APPLICA | Oct 31, 1984 | Substantially Equivalent | COOPER LASERSONICS, INC. |
| K840739 | MEDILASER-S MEL-444-S | Sep 20, 1984 | Substantially Equivalent | MOCHIDA PHARMACEUTICAL CO., LTD. |
| K834166 | BARD CO2 SURGICAL LASER SYS SLS-50/100 | Sep 18, 1984 | Substantially Equivalent | C.R. BARD, INC. |
| K840406 | MICROSURGICAL CO2 LASER SYS - 4100 | Aug 20, 1984 | Substantially Equivalent | BIO QUANTUM TECHNOLOGIES, INC. |
| K841234 | HALO CO LASER SYSTEM | Jul 09, 1984 | Substantially Equivalent | DIRECTED ENERGY, INC. |
| K832550 | SHARPLAN #734 LASER SURGICAL UNIT | Apr 25, 1984 | Substantially Equivalent | LASER INDUSTRIES LTD. |
| K832983 | DERMOLAS | Apr 23, 1984 | Substantially Equivalent | MEDITEC, INC. |
| K820327 | MODEL 450XL CO2 SURGICAL LASER | Mar 08, 1982 | Substantially Equivalent | LUMENIS, INC. |
| K820101 | SHARPLAN 720 CO2 SURGICAL LASER | Feb 24, 1982 | Substantially Equivalent | LASER INDUSTRIES LTD. |
| K801624 | SHARPLAN 723 CO2 LASER SURGICAL SYSTEM | Aug 20, 1980 | Substantially Equivalent | LASER INDUSTRIES LTD. |
| K792418 | SHARPLAN 743, CO2 LASER SURGICAL SYSTEM | Feb 05, 1980 | Substantially Equivalent | LASER INDUSTRIES LTD. |
| K791895 | ACCESSORIES FOR SYS. 400 CO2 SURG. LASER | Dec 20, 1979 | Substantially Equivalent | COHERENT MEDICAL DIVISION |
| K782030 | LASER SYSTEM, SHARPLAN 791/HE, CO2 | Jan 22, 1979 | Substantially Equivalent | LASER INDUSTRIES LTD. |
| K781453 | MODEL 770 ARGON LASER | Oct 24, 1978 | Substantially Equivalent | SPECTRA-PHYSICS, INC. |
| K780585 | SURGICAL LASER | Jul 19, 1978 | Substantially Equivalent | LASER INDUSTRIES LTD. |
FEI Numbers
This FDA classification entry is associated with 476 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 479 registration numbers. Click on an entry to view related FDA registrations.