Product Code: HQF
FDA class 2
21 CFR 886.4390
Laser, Ophthalmic
Ophthalmic
An Ophthalmic Laser is a surgical device that uses focused laser energy for a range of ophthalmic applications including retinal photocoagulation, glaucoma treatment (laser trabeculoplasty or iridotomy), posterior capsulotomy, and refractive procedures. This device is FDA Class 2 (moderate risk), requiring premarket notification (510(k)) before marketing. It carries product code HQF and is regulated under 21 CFR 886.4390, within the Ophthalmic medical specialty. It is eligible for third-party review.
510(k)s
177
FEI Numbers
61
Registration Numbers
62
Unique Applicants
93
Years Active
46
Basic Information
- Product Code
- HQF
- Device Class
- FDA class 2
- Regulation Number
- 886.4390
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 177 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K243014 | EyeQ nanoECP | Jun 18, 2025 | Substantially Equivalent | EyeQ Inc. |
| K240615 | Leos Laser and Endoscopy System | Apr 03, 2025 | Substantially Equivalent | Beaver-Visitec International, Inc. |
| K242397 | LYNX Photocoagulator | Oct 25, 2024 | Substantially Equivalent | Norlase Aps |
| K233911 | VISULAS combi | Sep 06, 2024 | Substantially Equivalent | Carl Zeiss Meditec AG |
| K232417 | MR Q; MR Q SUPINE; MR Q SLT | Jan 25, 2024 | Substantially Equivalent | Meridian AG |
| K230722 | Eagle device | Dec 08, 2023 | Substantially Equivalent | BELKIN Vision Ltd. |
| K232051 | VISULAS green | Oct 24, 2023 | Substantially Equivalent | Carl Zeiss Meditec |
| K230350 | VISULAS yag | Sep 22, 2023 | Substantially Equivalent | Carl Zeiss Meditec Inc |
| K231011 | Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse | Sep 12, 2023 | Substantially Equivalent | Meridian AG |
| K230228 | Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models) | Feb 23, 2023 | Substantially Equivalent | Iridex Corporation |
| K220974 | R:GEN | Dec 27, 2022 | Substantially Equivalent | Lutronic Vision, Inc. |
| K223132 | Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models) | Nov 09, 2022 | Substantially Equivalent | Iridex Corporation |
| K222395 | Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo | Nov 02, 2022 | Substantially Equivalent | Ellex Medical Pty Ltd |
| K222157 | ECHO Photocoagulator | Oct 11, 2022 | Substantially Equivalent | Norlase |
| K220877 | Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems | Jul 15, 2022 | Substantially Equivalent | Lumenis Be, Inc. |
| K220430 | Capsulo | May 12, 2022 | Substantially Equivalent | Quantel Medical |
| K213592 | Iridex 810 Laser | Mar 23, 2022 | Substantially Equivalent | Iridex Corporation |
| K212630 | Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo | Dec 16, 2021 | Substantially Equivalent | Ellex Medical Pty Ltd |
| K203130 | Ophthalmic Yag Laser System YC-200 | Dec 07, 2020 | Substantially Equivalent | Nidek Co., Ltd. |
| K202760 | Iridex 810 Laser | Oct 21, 2020 | Substantially Equivalent | Iridex Corporation |
| K201623 | LION Photocoagulator | Aug 11, 2020 | Substantially Equivalent | Norlase ApS |
| K201502 | Vitra 810 | Aug 06, 2020 | Substantially Equivalent | Quantel Medical |
| K192045 | Ophthalmic Yag Laser System YC-200 | Nov 15, 2019 | Substantially Equivalent | Nidek Co., Ltd. |
| K190448 | LightLas Pattern Scanning System - TruScan Pro | May 24, 2019 | Substantially Equivalent | Light-Med(USA), INC. |
| K190083 | Leaf Photocoagulator | May 03, 2019 | Substantially Equivalent | Norlase ApS |
| K181682 | VISULAS green | Mar 06, 2019 | Substantially Equivalent | Carl Zeiss Meditec AG |
| K180402 | PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar | May 25, 2018 | Substantially Equivalent | Topcon Medical Laser Systems, Inc. |
| K171488 | PSLT for PASCAL Streamline | Nov 27, 2017 | Substantially Equivalent | Topcon Medical Laser Systems, Inc. |
| K170067 | Easyret | Jul 25, 2017 | Substantially Equivalent | Quantel Medical |
| K170302 | YELLOW LASER PHOTOCOAGULATOR YLC-500 | Jun 23, 2017 | Substantially Equivalent | NIDEK CO., LTD. |
| K153769 | R:GEN Laser System | Oct 05, 2016 | Substantially Equivalent | Lutronic Corporation |
| K152688 | LightLas Multi-Wavelength Medical Laser System | Jun 15, 2016 | Substantially Equivalent | LIGHTMED CORPORATION |
| K152603 | Green Laser Photocoagulator GYC-500 | May 02, 2016 | Substantially Equivalent | NIDEK CO., LTD. |
| K142398 | Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-Yellow | Jul 14, 2015 | Substantially Equivalent | Ellex Medical Pty. Ltd. |
| K142830 | Ophthalmed Bending Laser Probes | Jun 25, 2015 | Substantially Equivalent | OPHTHALMED LLC |
| K142172 | LIGHTMED TRUSCAN 577 | Feb 27, 2015 | Substantially Equivalent | LIGHTMED CORP. |
| K133019 | FIBERION OPHTHALMIC ENDOLASER PROBE | Feb 20, 2015 | Substantially Equivalent | EMTRON ELEKTRONIK VE MEKANIK SANAYI VE TICARET LIM |
| K140362 | KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATALYST REVOLVER ILLUMINATED PROBES | Sep 15, 2014 | Substantially Equivalent | KATALYST SURGICAL, LLC |
| K133358 | NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT | Aug 12, 2014 | Substantially Equivalent | NIDEK CO., LTD |
| K140336 | OPTIMUS FUSION: SLT, YAG AND YAG/SLT | Jun 25, 2014 | Substantially Equivalent | QUANTEL MEDICAL |
| K130195 | SCANNING LASERLINK | Nov 01, 2013 | Substantially Equivalent | LUMENIS, INC. |
| K131207 | FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASER | Oct 09, 2013 | Substantially Equivalent | SURGICAL INSTRUMENT ENGINEERING AG |
| K124043 | LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM | Sep 26, 2013 | Substantially Equivalent | LIGHTMED CORP. |
| K130933 | SOLUTIS | Aug 02, 2013 | Substantially Equivalent | QUANTEL MEDICAL |
| K122202 | ELLEX 2RT | Jul 01, 2013 | Substantially Equivalent | Ellex Medical Pty. Ltd. |
| K123542 | PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER | May 15, 2013 | Substantially Equivalent | TOPCON MEDICAL LASER SYSTEMS, INC |
| K123056 | PASCAL LASER INDIRECT OPHTHALMOSCOPE | Nov 13, 2012 | Substantially Equivalent | TOPCON MEDICAL LASER SYSTEMS, INC. (TMLS) |
| K121187 | KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES | Sep 17, 2012 | Substantially Equivalent | KATALYST SURGICAL, LLC |
| K120825 | SUPRA SCAN DELIVERY SYSTEM | Sep 14, 2012 | Substantially Equivalent | QUANTEL MEDICAL |
| K111460 | OPTO HYALUS GREEN LASER | Aug 20, 2012 | Substantially Equivalent | OPTO ELETRONICA S/A |
| K112154 | FEMTO LDV | Mar 16, 2012 | Substantially Equivalent | SIE AG,SURGICAL INSTUMENT ENGINEERING |
| K111643 | OPTO MITRA YELLOW LASER | Nov 03, 2011 | Substantially Equivalent | OPTO ELECTRONICA SA |
| K103547 | LIGHTLAS MULTI-WAVELENGTH MEDICAL LASER SYSTEM | Nov 03, 2011 | Substantially Equivalent | LIGHTMED CORP. |
| K111108 | PASCAL STREAMLINE 577 (WITH ACCESSORIES) | Aug 11, 2011 | Substantially Equivalent | TOPCON MEDICAL LASER SYSTEMS, INC |
| K103056 | VISULAS TRION LASER SYSTEM WITH THE VITE OPTION | Feb 01, 2011 | Substantially Equivalent | CARL ZEISS MEDITEC AG |
| K100253 | VISUMAX LASER KERATOME | Jul 08, 2010 | Substantially Equivalent | CARL ZEISS MEDITEC AG |
| K100019 | PASCAL STREAMLINE PHOTOCOAGULATOR | May 04, 2010 | Substantially Equivalent | OPTIMEDICA CORPORATION |
| K091064 | NAVILAS LASER SYSTEM | Oct 27, 2009 | Substantially Equivalent | OD -OS GMBH |
| K091981 | LIGHTLAS 577 MEDICAL OPTICAL PUMPED SEMICONDUCTOR LASER | Sep 28, 2009 | Substantially Equivalent | LIGHTMED CORP. |
| K092621 | PASCAL STREAMLINE PHOTOCOAGULATOR | Sep 25, 2009 | Substantially Equivalent | TOPCON MEDICAL LASER SYSTEMS, INC |
| K091534 | LIGHTLAS MODEL 532 | Sep 18, 2009 | Substantially Equivalent | LIGHTMED CORP. |
| K090774 | LIGHTLAS SELECTOR | Aug 13, 2009 | Substantially Equivalent | LIGHTMED CORP. |
| K091581 | SUPRA 577.Y LASER | Jun 16, 2009 | Substantially Equivalent | QUANTEL MEDICAL |
| K081946 | SUPRA TWIN OPHTHALMIC LASER PHOTOCOAGULATOR | Mar 25, 2009 | Substantially Equivalent | QUANTEL MEDICAL |
| K081774 | SOLX 790 TITANIUM SAPPHIRE LASER | Sep 12, 2008 | Substantially Equivalent | SOLX INC. |
| K081565 | INTEGRE PRO, MODEL L2RY | Jul 02, 2008 | Substantially Equivalent | Ellex Medical Pty. Ltd. |
| K080423 | INTEGRE, MODEL LP581 | Mar 11, 2008 | Substantially Equivalent | Ellex Medical Pty. Ltd. |
| K072823 | MERILAS 532A | Dec 14, 2007 | Substantially Equivalent | MERIDIAN AG |
| K062624 | NEXT GENERATION LASER | Nov 05, 2007 | Substantially Equivalent | ALCON LABORATORIES |
| K063297 | LIGHTLAS 561 OPTHALMIC PHOTOCOAGULATOR | Sep 20, 2007 | Substantially Equivalent | LIGHTMED CORP. |
| K070776 | SUPRA OPHTHALMIC LASER PHOTOCOAGULATOR | Apr 24, 2007 | Substantially Equivalent | QUANTEL MEDICAL |
| K062074 | IRIDEX WIRELESS FOOTSWITCH | Nov 14, 2006 | Substantially Equivalent | IRIDEX CORP. |
| K061024 | PEREGRINE SOFT TIP ASPIRATING LASER PROBE, MODEL PD720.60 | Jun 21, 2006 | Substantially Equivalent | PEREGRINE SURGICAL LTD. |
| K051944 | FAMILY OF SELECTA OPHTHALMIC LASER SYSTEMS (SELECTA 1064, SELECTA SLT, SELECTA DUO), DELIVERY DEVICE AND ACCESSORIES | Sep 30, 2005 | Substantially Equivalent | LUMENIS, INC. |
| K050807 | 20G SMA LASER FIBER, MODEL LF100 | Sep 21, 2005 | Substantially Equivalent | OPHTHALMED LLC |
| K050541 | OMNIGUIDE BEAMPATH CO2 MARK I LASER BEAM DELIVERY | May 09, 2005 | Substantially Equivalent | OMNIGUIDE COMMUNICATIONS, INC. |
| K043613 | Q-SWITCHED ND:YAG OPHTALMIC LASER (WITH SLIT LAMP), MODEL OPTIMIS II | Mar 24, 2005 | Substantially Equivalent | QUANTEL MEDICAL |
| K043236 | FREQUENCY DOUBLED ND: YAG PHOTOCOAGULATOR, MODEL VITRA | Feb 07, 2005 | Substantially Equivalent | QUANTEL MEDICAL |
| K041598 | LASEREX, MODEL LP4532 | Oct 06, 2004 | Substantially Equivalent | Ellex Medical Pty. Ltd. |
| K040209 | IRIS MEDICAL IQ 810 PHOTOCOAGULATOR | Sep 20, 2004 | Substantially Equivalent | IRIDEX CORP. |
| K033941 | MILLENNIUM MICROSURGICAL SYSTEM AND PERISTALTIC PHACO PACK | Feb 10, 2004 | Substantially Equivalent | BAUSCH & LOMB, INC. |
| K031665 | IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS | Aug 27, 2003 | Substantially Equivalent | IRIDEX CORP. |
| K031023 | PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10 | Jun 27, 2003 | Substantially Equivalent | PEREGRINE SURGICAL LTD. |
| K023094 | IRIDIS OPHTHALMIC PHOTOCOAGULATOR | Dec 17, 2002 | Substantially Equivalent | QUANTEL MEDICAL |
| K021538 | LIGHTLAS 810 INFRARED LASER PHOTOCOAGULATOR | Aug 08, 2002 | Substantially Equivalent | LIGHTMED CORP. |
| K020374 | OCULIGHT SL/SLX | May 03, 2002 | Substantially Equivalent | IRIDEX CORP. |
| K013760 | DC-3300 LASER DIODE PHOTOCOAGULATOR | Feb 11, 2002 | Substantially Equivalent | NIDEK, INC. |
| K010372 | LIGHTLAS 532 PHOTOCOAGULATOR | Aug 22, 2001 | Substantially Equivalent | LIGHTMED CORP. |
| K001772 | LASEREX ERA ARTICULATED ARM KIT, MODEL LQP4106-AA | Jul 06, 2000 | Substantially Equivalent | TARACAN PTY. LTD. |
| K990665 | BQ/BM INTEGRATED LASER DELIVERY SYSTEM | May 17, 1999 | Substantially Equivalent | AMERICAN LASER CORP. |
| K990075 | LPULSA SYL-9000 OPHTHALMIC YAG LASER | Mar 30, 1999 | Substantially Equivalent | LIGHT-MED (USA), INC. |
| K981196 | MEDITEC LINK | Jun 17, 1998 | Substantially Equivalent | AESCULAP-MEDITEC NORTH AMERICA |
| K973193 | LUXSCOPE | Nov 21, 1997 | Substantially Equivalent | LUXTEC CORP. |
| K973220 | RODENSTOCK LASER SLITLAMP | Nov 04, 1997 | Substantially Equivalent | G. RODENSTOCK INSTRUMENTE GMBH |
| K972514 | LASEREX LP1532 PHOTOCOAGULATOR | Oct 03, 1997 | Substantially Equivalent | Ellex Medical Pty. Ltd. |
| K971950 | INFINITECH MULTI-SPOT SLIT LAMP LASER ADAPTER | Aug 01, 1997 | Substantially Equivalent | INFINITECH, INC. |
| K964751 | CERALAS DIODE LASER SYSTEM (CERALAS D2) | Feb 21, 1997 | Substantially Equivalent | CERAMOPTEC, INC. |
| K960971 | OCULIGHT GL | Aug 28, 1996 | Substantially Equivalent | IRIDERM DIV. |
| K960522 | DIOPEXY PROBE | Jul 19, 1996 | Substantially Equivalent | IRIDERM DIV. |
| K951079 | NIDEK MODEL GYC-1500 AND GYC-2000 | Sep 14, 1995 | Substantially Equivalent | NIDEK, INC. |
| K952894 | VISULINK 900 ARGON | Aug 14, 1995 | Substantially Equivalent | CARL ZEISS, INC. |
| K942180 | KEELER MULTILASE 3000 | Nov 22, 1994 | Substantially Equivalent | KEELER INSTRUMENTS, INC. |
| K935747 | MEGABEAM ENDOCULAR PROBE | Apr 01, 1994 | Substantially Equivalent | CERAMOPTEC, INC. |
| K931784 | HGM ILLUMINATING IMAGING ENDOCULAR PROBE | Mar 01, 1994 | Substantially Equivalent | HGM, INC. |
| K932836 | NIDEK MODEL AC-2300 | Nov 22, 1993 | Substantially Equivalent | NIDEK, INC. |
| K932296 | JR -- OPHTHALMIC ARGON LASER | Nov 12, 1993 | Substantially Equivalent | CARSON LASERWORKS |
| K925663 | HGM ASPIRATING ENDOOCULAR(TM) PROBE | Aug 17, 1993 | Substantially Equivalent | HGM, INC. |
| K926470 | LASER AND EMPHASIS SCLEROSTOMY TIP | Jul 22, 1993 | Substantially Equivalent | SUMMIT TECHNOLOGY, INC. |
| K910532 | URAM OPHTHALMIC LASER ENDOSCOPE | May 28, 1991 | Substantially Equivalent | MARTIN S. KNOPF ASSOC., INC. |
| K910805 | ND:YAG LASER SYSTEMS (VARIOUS MODELS) | May 24, 1991 | Substantially Equivalent | HERAEUS LASERSONICS, INC. |
| K904699 | COMPAC(TM) DIODE LASERS | Apr 25, 1991 | Substantially Equivalent | HGM MEDICAL LASER SYSTEMS, INC. |
| K905453 | CRYSTAL FOCUS EMERALD LASER/SLT OPHF 0.6 ENDO HAND | Mar 05, 1991 | Substantially Equivalent | DOUGLAS JAMES DONALDSON COMPLIANCE SERVICES |
| K910612 | CANDELA DIODE TRABECULOPLASTY LASER DTL | Mar 04, 1991 | Substantially Equivalent | CANDELA LASER CORP. |
| K905141 | CENTAURI | Feb 11, 1991 | Substantially Equivalent | PFIZER LASER SYSTEMS |
| K903421 | TOPCON EC-200 ENDO-PHOTOCOAGULATOR LASER | Dec 18, 1990 | Substantially Equivalent | TOP CON |
| K904366 | CRYSTAL FOCUS EMERALD-CW LASER PHOTOCOAGULATOR | Oct 19, 1990 | Substantially Equivalent | DOUGLAS JAMES DONALDSON COMPLIANCE SERVICES |
| K900199 | LASAG MICRORUPTER 2 ND:YAG LASER TRABECULOPLASTY | Mar 27, 1990 | Substantially Equivalent | LASAG AG |
| K895213 | MICROLASE BY LASER TRABECULOPLASTY | Oct 31, 1989 | Substantially Equivalent | KEELER INSTRUMENTS, INC. |
| K895196 | MODEL DC-1200 DIODE LASER PHOTOCOAGULATOR | Oct 16, 1989 | Substantially Equivalent | NIDEK, INC. |
| K894835 | LASERMED* GOGGLES AND SPECTACLES | Sep 21, 1989 | Substantially Equivalent | GLENDALE PROTECTIVE TECHNOLOGIES, INC. |
| K894273 | NIDEK MODEL AKC-8000 | Aug 07, 1989 | Substantially Equivalent | NIDEK, INC. |
| K893630 | CANDELA UPC LASER PHOTOCOAGULATOR | Aug 02, 1989 | Substantially Equivalent | CANDELA LASER CORP. |
| K893709 | COHERENT MARIE ARGON PHOTOCOAGULATOR | Jun 15, 1989 | Substantially Equivalent | COHERENT MEDICAL GROUP |
| K890509 | INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEM | Mar 24, 1989 | Substantially Equivalent | BIOPHYSIC MEDICAL, INC. |
| K890086 | MICROLASE 8 0 0 (OPHTHALMIC LASER) | Mar 15, 1989 | Substantially Equivalent | KEELER INSTRUMENTS, INC. |
| K885164 | LASAG MICRORUPTOR 2 ND:YAG OPHTH. LASER SYSTEM | Jan 10, 1989 | Substantially Equivalent | CHIRON VISION CORP. |
| K882908 | SLT CL60 CONTACT LASER SYSTEM, CUTTING & COAGULA. | Sep 30, 1988 | Substantially Equivalent | SURGICAL LASER TECHNOLOGIES, INC. |
| K883213 | NIDEK OPEATING MICROSCOPE DELIVERY SYSTEM (OMDS) | Sep 15, 1988 | Substantially Equivalent | NIDEK, INC. |
| K881494 | FOUR MODIFICATIONS TO OPHTHALAS ARGON/DYE LASER | Aug 30, 1988 | Substantially Equivalent for Some Indications | BIOPHYSIC MEDICAL, INC. |
| K882372 | RESUBMITTED DIODE LASER COAGULATOR | Aug 02, 1988 | Substantially Equivalent | COOPERVISION, INC. |
| K881134 | SLT CONTACT LASER SYSTEM OCULOPLASTICS | Jun 06, 1988 | Substantially Equivalent | SURGICAL LASER TECHNOLOGIES, INC. |
| K875000 | PRISMA DISPOSABLE ENDO-OCULAR PROBE | Apr 13, 1988 | Substantially Equivalent | ADVANCED SURGICAL PRODUCTS, INC. |
| K874609 | ZEISS VISULAS ARGON LASER | Jan 06, 1988 | Substantially Equivalent | CARL ZEISS, INC. |
| K873460 | OPHTHALAS DYE OPHTHALMIC LASER | Oct 29, 1987 | Substantially Equivalent | BIOPHYSIC MEDICAL, INC. |
| K872846 | NIDEK ADC-8000 LASER SYSTEM | Oct 15, 1987 | Substantially Equivalent | NIDEK, INC. |
| K870839 | MODEL 10-C W/FL-10A/U OPTICAL ATTACHMENT/OPTHALMIC | May 22, 1987 | Substantially Equivalent | DIRECTED ENERGY, INC. |
| K864063 | ORION 3001, LASER PHOTOCOAGULATOR | Nov 13, 1986 | Substantially Equivalent | G. RODENSTOCK INSTRUMENTE GMBH |
| K863246 | MIRALITE | Oct 31, 1986 | Substantially Equivalent | MIRA, INC. |
| K863591 | ENDOPHOTOCOAGULATION PROBE | Oct 10, 1986 | Substantially Equivalent | MIRA, INC. |
| K862568 | LDS - LASER DELIVERY SYSTEM | Oct 07, 1986 | Substantially Equivalent | COHERENT MEDICAL GROUP |
| K862987 | MODEL 1000 OPHTHALMIC LASER SYSTEM | Sep 24, 1986 | Substantially Equivalent | COOPERVISION, INC. |
| K860358 | FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE (STERILE) | Mar 21, 1986 | Substantially Equivalent | HGM, INC. |
| K854949 | MODEL 9500 ARGON, KRYPTON & DYE SURGICAL LASER SYS | Feb 04, 1986 | Substantially Equivalent | COOPERVISION, INC. |
| K854288 | OPHALMIC LASER PHOTOCOAGULATOR | Nov 12, 1985 | Substantially Equivalent | MIRA, INC. |
| K853890 | OPHTHALMIC LASER PHOTOCOAGULATOR | Nov 12, 1985 | Substantially Equivalent | MIRA, INC. |
| K852529 | HESSBURG GLIDE UNTRAOCULAR LENS GUIDES | Sep 24, 1985 | Substantially Equivalent | VISITEC CO. |
| K852234 | MDS 83 OPHTHALMIC DYE LASER SYSTEM | Aug 01, 1985 | Substantially Equivalent | MEDITEC, INC. |
| K852464 | HCG, INC. MEDICAL LASER ENDOCOAGULATOR MODEL P.C. | Jul 25, 1985 | Substantially Equivalent | HCG, INC. |
| K844357 | SYSTEM 920 ARGON/DYE PHOTOCOAGULATOR | Jun 05, 1985 | Substantially Equivalent | COHERENT MEDICAL GROUP |
| K850572 | HGM, INC. MEDICAL LASER ENDOCOAGULATOR MODEL 8-K | Apr 23, 1985 | Substantially Equivalent | HGM, INC. |
| K844668 | MODEL 8000 ND:YAG LASER SYS TREATMENT OF BENIGN LE | Jan 03, 1985 | Substantially Equivalent | COOPER LASERSONICS, INC. |
| K844358 | SYSTEM 920 PHOTOCOAGULATOR TO INCLUDE SCHIRMERSCOP | Jan 03, 1985 | Substantially Equivalent | COHERENT MEDICAL GROUP |
| K843965 | ARGON LASER PHOTOCOAGULATOR SYS | Nov 06, 1984 | Substantially Equivalent | AMERICAN MEDICAL OPTICS |
| K842251 | AMERI. MEDICAL OPTICS ARGON LASER PHOTO | Aug 15, 1984 | Substantially Equivalent | AMERICAN MEDICAL OPTICS |
| K842250 | AMER. MEDICAL OPTICS ARGON/KRYPTON LASE | Aug 15, 1984 | Substantially Equivalent | AMERICAN MEDICAL OPTICS |
| K842412 | MODEL 4000 MD-YAG LASER FOR MALIGNANT | Jun 26, 1984 | Substantially Equivalent | COOPER LASERSONICS, INC. |
| K841855 | AMER. MED. OPTICS ARGON LASER PHOTO | Jun 19, 1984 | Substantially Equivalent | AMERICAN MEDICAL OPTICS |
| K841856 | AMER. MED. OPTICS ARGON/KRYPTON LASER | Jun 07, 1984 | Substantially Equivalent | AMERICAN MEDICAL OPTICS |
| K840590 | FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE | May 09, 1984 | Substantially Equivalent | HGM, INC. |
| K840145 | MONITOR CO2 LASER SURGICAL SYSTEM | Apr 25, 1984 | Substantially Equivalent | COOPER LASERSONICS, INC. |
| K834610 | LASER LENS-VARIOUS MODELS | Apr 05, 1984 | Substantially Equivalent | MEDITEC OF AMERICA |
| K840854 | MEDICAL LASER ENDOCOAGULATOR 5K | Apr 02, 1984 | Substantially Equivalent | HGM, INC. |
| K834305 | ARGON/KRYPTON ION LASER PHOTOCOAGULA | Mar 16, 1984 | Substantially Equivalent | NIDEK, INC. |
| K834060 | RELIANCE OPHTHALMIC SLIT LAMP R-083 | Feb 04, 1984 | Substantially Equivalent | F. & F. KOENIGKRAMER |
| K833532 | OCULASE 514 OPHTHALMIC ARGON LASER | Feb 04, 1984 | Substantially Equivalent | LASERMED CORP. |
| K833533 | LASER PHOTOCOAGULATOR 1520-A & K | Jan 30, 1984 | Substantially Equivalent | BRITT CORP., INC. |
| K832316 | OPHTHALMIC ARGON LASER #700A | Jan 30, 1984 | Substantially Equivalent | LASER INDUSTRIES LTD. |
| K832089 | MODEL 150K LASER COAGULATOR | Jan 30, 1984 | Substantially Equivalent | LASERTEK OY |
| K833232 | LASER PROTECTIVE EYESHIELD | Dec 30, 1983 | Substantially Equivalent | STEFANOVSKY & ASSOC. |
| K833274 | DERMATOLOGY HANDPIECE-OPHTH LASER | Dec 03, 1983 | Substantially Equivalent | SYNEMED, INC. |
| K813492 | BRITT KRYPTON LASERS 150K & 152K | Jan 22, 1982 | Substantially Equivalent | BRITT CORP., INC. |
| K812219 | MODEL 900S INTRAOCULAR PROBE | Nov 16, 1981 | Substantially Equivalent | LUMENIS, INC. |
| K801336 | MODEL 900K PHOTOCOAGULATOR | Jul 28, 1980 | Substantially Equivalent | COHERENT MEDICAL DIVISION |
| K791659 | MEDITEC (RODENSTOCK) LASER PHOTOCOAGUL | Oct 11, 1979 | Substantially Equivalent | COBURN OPTICAL IND., INC. |
| K782106 | COAGULATOR, MODEL 40 AARGON | Feb 08, 1979 | Substantially Equivalent | LASERTEK OY |
| K781965 | LASER COAGULATOR, MODEL 41AK | Feb 08, 1979 | Substantially Equivalent | LASERTEK OY |
| K782065 | LASER, PHOTOCOAGULATION | Dec 28, 1978 | Substantially Equivalent | CAVITRON CORP. |
FEI Numbers
This FDA classification entry is associated with 61 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 62 registration numbers. Click on an entry to view related FDA registrations.