Product Code: ILY
FDA class 2
21 CFR 890.5500
Lamp, Infrared, Therapeutic Heating
Physical Medicine
A Therapeutic Heating Infrared Lamp is a device used in Physical Medicine that emits infrared radiation to provide superficial radiant heat therapy to the body surface, used to relieve pain, reduce muscle spasm, increase local circulation, and facilitate tissue healing. It is classified as FDA Class 2, representing moderate risk, meaning it requires a 510(k) premarket notification demonstrating substantial equivalence to a predicate device before marketing. The product code is ILY, regulated under 21 CFR 890.5500, within the Physical Medicine medical specialty.
510(k)s
228
FEI Numbers
423
Registration Numbers
423
Unique Applicants
170
Years Active
40
Basic Information
- Product Code
- ILY
- Device Class
- FDA class 2
- Regulation Number
- 890.5500
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 4
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 228 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K242755 | Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B) | May 19, 2025 | Substantially Equivalent | Gigaalaser Company Ltd. |
| K231997 | SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) | Oct 15, 2024 | Substantially Equivalent | Cure Point Therapeutics, Inc. |
| K223642 | LED Lip Perfector, model: ZC-05 | Mar 09, 2023 | Substantially Equivalent | Light Tree Ventures Europe B.V. |
| K221189 | OLIZ LTB-1000A | Aug 29, 2022 | Substantially Equivalent | LTBIO Co., Ltd. |
| K213524 | CytonPro-5000 | Aug 10, 2022 | Substantially Equivalent | Cytonsys Inc |
| K202028 | dermalux Flex MD | Dec 16, 2020 | Substantially Equivalent | Aesthetic Technology Ltd |
| K171087 | AXON IR Heat Lamp | Jul 07, 2017 | Substantially Equivalent | Crystal Medtech, LLC |
| K163079 | HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System | Jun 13, 2017 | Substantially Equivalent | HealthLight, LLC |
| K170068 | Softcure 96 | May 05, 2017 | Substantially Equivalent | WELLRAY MEDICAL LASER, INC. |
| K162590 | Bashan TDP Heat Lamp | Feb 14, 2017 | Substantially Equivalent | Chogqing YUHE Medical Instruments Co., Ltd. |
| K162763 | Vevazz LED Heat Lamp | Jan 05, 2017 | Substantially Equivalent | Vevazz, LLC |
| K160849 | WS(TM) Far-Infrared Therapy Unit, Model KP-B210 | Dec 15, 2016 | Substantially Equivalent | WS FAR IR MEDICAL TECHNOLOGY CO., LTD. |
| K152087 | HeatLux Pro II | Jul 29, 2016 | Substantially Equivalent | HOME SKINOVATIONS LTD. |
| K161198 | Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 | Jul 26, 2016 | Substantially Equivalent | USA LASER BIOTECH INC. |
| K152461 | The Time Machine Series Lasers | Jul 08, 2016 | Substantially Equivalent | MEDICAL LASERS MANUFACTURER INC. |
| K160947 | LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX CPS 4 IR Lamp System LUMIX CPS 5 IR Lamp System | Jul 05, 2016 | Substantially Equivalent | USA LASER BIOTECH INC. |
| K153399 | LightStim Professional LED Bed | Jul 05, 2016 | Substantially Equivalent | LED Intellectual Properties LLC |
| K153389 | Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom) | Mar 30, 2016 | Substantially Equivalent | IN LIGHT WELLNESS SYSTEMS, INC. |
| K152280 | BioPhotas Celluma3 | Mar 02, 2016 | Substantially Equivalent | BIOPHOTAS, INC |
| K150716 | Varaya Sport | Dec 08, 2015 | Substantially Equivalent | VARAYA PHOTOCEUTICALS, LLC |
| K150554 | NuBrilliance Light Pain Therapy | Oct 06, 2015 | Substantially Equivalent | WELLQUEST INTERNATIONAL, INC. |
| K151521 | Phoenix Thera-Lase System | Sep 04, 2015 | Substantially Equivalent | PHOENIX THERA-LASE SYSTEMS, LLC |
| K151333 | LightStim for Pain LED Belt | Aug 21, 2015 | Substantially Equivalent | LED INTELLECTUAL PROPERTIES, LLC |
| K150466 | ZX2 Laser System | Jun 08, 2015 | Substantially Equivalent | LZR7, Inc |
| K150175 | HeatLux Pro I | Mar 31, 2015 | Substantially Equivalent | HOME SKINOVATIONS LTD. |
| K141892 | QK-SYSTEMIC THERAPEUTIC APPARATUS | Jan 28, 2015 | Substantially Equivalent | HARBIN QUANKE MEDI-TECHNICAL DEVELOPMENT CO., LTD. |
| K142025 | NEUROLUMEN PN-1000 | Jan 21, 2015 | Substantially Equivalent | NEUROLUMEN, LLC |
| K142722 | 3B Laser 500, 3B Laser 200, LA-X P 500, LA-X P 200 | Jan 13, 2015 | Substantially Equivalent | Livetec GMBH |
| K142256 | Applied BioPhotonics Phototherapy System ABPT1003 | Jan 07, 2015 | Substantially Equivalent | APPLIED BIOPHOTONICS LTD. |
| K141861 | HILTHERA 4.0 | Jan 07, 2015 | Substantially Equivalent | JEISYS MEDICAL, INC. |
| K142340 | Infrared Therapy System | Dec 02, 2014 | Substantially Equivalent | Beijing Huatai Healthcare Technology Co., Ltd. |
| K142215 | Power Twin21-50/Power Twin21-100 | Nov 07, 2014 | Substantially Equivalent | LIVETEC GMBH |
| K142078 | VELASII THERAPY LASER SYSTEM | Oct 30, 2014 | Substantially Equivalent | ASPEN LASER SYSTEMS, LLC |
| K141564 | OPTON PRO | Oct 24, 2014 | Substantially Equivalent | ZIMMER MEDIZINSYSTEMS GMBH |
| K140865 | INFRARED HEATING DEVICE | Sep 03, 2014 | Substantially Equivalent | PRO MEDICAL SUPPLIES, INC. |
| K131080 | PHYSIOLASER OLYMPIC, SINGLE PROBES CW, CLUSTER PROBES CW, LIGHT NEEDLE, PHOTONIC SATELLITE | Jun 13, 2014 | Substantially Equivalent | REIMERS AND JANSSEN GMBH |
| K132016 | LUMIX 3 PLUS AND LUMIX 3 ULTRA SYSTEM | Jun 02, 2014 | Substantially Equivalent | TEXAS APPLIED BIOMEDICAL SERVICES, INC. |
| K132529 | GALLIEON-1 MEDICAL LASER | May 12, 2014 | Substantially Equivalent | FUTURE DEVICE AND TECHNOLOGY, INC |
| K134017 | GIGALASER | May 02, 2014 | Substantially Equivalent | POWERMEDIC APS |
| K131113 | BIOPHOTAS CELLUMA | Jan 15, 2014 | Substantially Equivalent | BIOPHOTAS, INC. |
| K130168 | CL10009 IR LASER | Jan 10, 2014 | Substantially Equivalent | CURAE'LASE INC. |
| K131259 | LASER-STIM | Dec 27, 2013 | Substantially Equivalent | SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. |
| K123474 | AVANT LASER | Dec 03, 2013 | Substantially Equivalent | AVANT WELLNESS SYSTEMS, LLC |
| K130866 | BIOLIGHT BIODYNAM | Oct 25, 2013 | Substantially Equivalent | BIOLIGHT AB |
| K131797 | 3B LASER NEEDLE | Oct 10, 2013 | Substantially Equivalent | LIVETEC GMBH |
| K123177 | STIMLASE 2000 LOW LEVEL LASER THERAPY SYSTEM | Jul 03, 2013 | Substantially Equivalent | LASERSTIM, INC. |
| K123971 | CYNOSURE 1064NM DIODE LASER | May 02, 2013 | Substantially Equivalent | CYNOSURE, INC. |
| K121401 | TENDER TOUCH | May 01, 2013 | Substantially Equivalent | SOMETECH CORPORATION |
| K122125 | ASA LASER SH1 | Jan 25, 2013 | Substantially Equivalent | EL.EN. ELECTRONIC ENGINEERING SPA |
| K122237 | BIOPHOTAS LIFELIGHT | Jan 03, 2013 | Substantially Equivalent | BIOPHOTAS, INC. |
| K121363 | DIOWAVE LOW LEVEL COLD LASER SYSTEM | Nov 23, 2012 | Substantially Equivalent | TECHNOLOGICAL MEDICAL ADVANCMENTS, INC. (TMA) |
| K110558 | CS1000 LIGHT THERAPY DEVICE | Jul 12, 2012 | Substantially Equivalent | GENESIS HEALTH LIGHT CORPORATION |
| K120582 | HEATLUX | Jul 06, 2012 | Substantially Equivalent | HOME SKINOVATIONS LTD. |
| K113668 | HEALITE II SYSTEM | Jun 19, 2012 | Substantially Equivalent | LUTRONIC CORPORATION |
| K121487 | LITECURE THERAPY COMPACT | Jun 12, 2012 | Substantially Equivalent | LITECURE, LLC |
| K120604 | K-LASER | May 25, 2012 | Substantially Equivalent | ELTECH S.R.L |
| K112494 | VARAYA AR , VARAYA SPORT | May 16, 2012 | Substantially Equivalent | VARAYA PHOTOCEUTICALS, LLC |
| K120254 | THERASAGE HEATING PAD | Mar 06, 2012 | Substantially Equivalent | THERASAGE CORPORATION |
| K113231 | WARP10,WARP75 | Feb 27, 2012 | Substantially Equivalent | QUANTUM DEVICES, INC. |
| K112016 | L-SER KO LAMP | Feb 10, 2012 | Substantially Equivalent | YA-MAN LTD |
| K113250 | DYNATRON TRI-WAVE LIGHT PAD DYNATRON TRI-WAVE LIGHT PROBE | Feb 09, 2012 | Substantially Equivalent | DYNATRONICS CORP. |
| K111901 | ASA 'MPHI FAMILY DIODE LASER | Nov 09, 2011 | Substantially Equivalent | CYNOSURE, INC. |
| K110342 | YOLO CURVE | Aug 22, 2011 | Substantially Equivalent | YOLO MEDICAL INC. |
| K110721 | GAUNYING INFRARED LAMP | Mar 30, 2011 | Substantially Equivalent | FOSHAN GAUNYING ELECTRONICS CO., LTD. |
| K102375 | LUCIA | Feb 25, 2011 | Substantially Equivalent | MERIDIAN CO., LTD. |
| K101893 | NEXUS BIOWAVE 7W LITE IR LAMP SYSTEM, NEXUS BIOWAVE 10W LITE IR LAMP SYSTEM, NEXUS BIOWAVE 30W PRO IR LAMP SYSTEM, NEXUS | Feb 17, 2011 | Substantially Equivalent | USA LASER BIOTECH INC. |
| K103511 | LITECURE THERAPY SYSTEM | Jan 25, 2011 | Substantially Equivalent | LITECURE, LLC |
| K101894 | HEALTHLIGHT MICROCONTROLLER, MINIPRO, PRONEUROLIGHT, AND PRO UNIT | Jan 21, 2011 | Substantially Equivalent | BIOREMEDI THERAPEUTIC SYSTEMS, INC |
| K101716 | HVR PAIN RELIEF DEVICE | Jan 11, 2011 | Substantially Equivalent | H.V.R., INC. |
| K101693 | GAUNYING INFRARED LAMP MODEL IL50 | Jan 05, 2011 | Substantially Equivalent | FOSHAN GAUNYING ELECTRONICS CO., LTD. |
| K102134 | MODEL LA-1200 MULTI-CHANNEL LASER THERAPY SYSTEM | Dec 23, 2010 | Substantially Equivalent | UNITED INTEGRATED SERVICES CO., LTD. |
| K101267 | PREMIO 10 MOXA | Dec 03, 2010 | Substantially Equivalent | SEDATELEC |
| K100213 | LUMANOSITY CELEBRITY, MODEL 204 | Oct 04, 2010 | Substantially Equivalent | LUMANOSITY, INC |
| K093204 | INNOVATIVE MED MULTI WAVE LIGHT THERAPY SYSTEM | Aug 23, 2010 | Substantially Equivalent | INNOVATIVE MED, INC. |
| K102149 | GAUNYING INFRARED LAMP | Aug 13, 2010 | Substantially Equivalent | FOSHAN GAUNYING ELECTRONICS CO., LTD. |
| K101227 | BACK-TEK | Jun 23, 2010 | Substantially Equivalent | YORK BIOMEDICAL INC |
| K090250 | ELECTRO-LIGHT THERAPY | Feb 11, 2010 | Substantially Equivalent | HILL LABORATORIES CO. |
| K092589 | THERMOTEX PLATINUM SYSTEM | Jan 28, 2010 | Substantially Equivalent | EAS CONSULTING GROUP LLC |
| K091675 | LASERPEN PRACTISE AND EXPERT, HANDYLASER SPRINT, HANDYLASER TRION, PHYSIOLASER OLYMPIC, POLYLASER | Dec 15, 2009 | Substantially Equivalent | REIMERS AND JANSSEN GMBH |
| K091726 | NEXUS XPULSE 805 IR LAMP SYSTEM, NEXUS XPULSE 980 IR LAMP SYSTEM, MODEL 805, 980 | Oct 28, 2009 | Substantially Equivalent | USA LASER BIOTECH INC. |
| K090008 | TANDA RESTORE, MODEL PTSCS | Oct 15, 2009 | Substantially Equivalent | PHAROS LIFE CORPORATION |
| K092222 | THERMAPULSE | Aug 20, 2009 | Substantially Equivalent | PALOMAR MEDICAL PRODUCTS, INC. |
| K091497 | K-LASER K-1200, MODEL 12 W | Aug 19, 2009 | Substantially Equivalent | ELTECH, S.R.L. |
| K091158 | SCALAR WAVE LASER SYSTEM | Aug 10, 2009 | Substantially Equivalent | STELLAR LASERS |
| K091285 | AL T LASER, MODEL AVI HPLL-12 | Jul 28, 2009 | Substantially Equivalent | AVICENNA LASER TECHNOLOGY, INC. |
| K083183 | AKLARUS PHOTOTHERAPY SYSTEM | Jul 16, 2009 | Substantially Equivalent | HILL LABORATORIES CO. |
| K083580 | ANTI-WRINKLE LIGHT, MODEL 1302 AND PAIN THERAPY LIGHT, MODEL 1301 | Jun 22, 2009 | Substantially Equivalent | LED INTELLECTUAL PROPERTIES, LLC |
| K081720 | PRECISION TDP, HEAT AND INFRARED LAMPS AND MARVEL AND WONDER LAMPS | Jun 16, 2009 | Substantially Equivalent | PRIME HERBS CORPORATION |
| K082686 | MULTI-CHANNEL LASER THERAPY SYSTEM | May 11, 2009 | Substantially Equivalent | UNITED INTEGRATED SERVICES CO., LTD. |
| K082223 | NEUTROLUMENPN SYSTEM, MODEL 1000 | Apr 21, 2009 | Substantially Equivalent | NEUROLUMEN, LLC |
| K083595 | EZLASE | Apr 14, 2009 | Substantially Equivalent | BIOLASE TECHNOLOGY, INC. |
| K081962 | LAPEX BCS | Dec 29, 2008 | Substantially Equivalent | MERIDIAN CO., LTD. |
| K081355 | BIOFLEX LD-R100 TREATMENT HEAD | Dec 18, 2008 | Substantially Equivalent | MEDITECH INTERNATIONAL, INC. |
| K083560 | EXPANDED SPECTRUM PHOTO THERAPY DEVICE, MODEL ESPT-3X | Dec 11, 2008 | Substantially Equivalent | LIGHTHOUSE TECHNICAL INNOVATIONS, INC. |
| K073681 | NANOBEAM 940, MODEL 940-900-02 | Dec 09, 2008 | Substantially Equivalent | DAVARAY, INC. |
| K081505 | THERAGEM PROFESSIONAL T1002 | Nov 19, 2008 | Substantially Equivalent | MEDICA HEALTH, LTD |
| K081570 | DPL THERAPY SYSTEM | Nov 07, 2008 | Substantially Equivalent | LED TECHNOLOGIES, LLC |
| K082969 | LUMINEX INFRARED LAMP SYSTEM | Oct 23, 2008 | Substantially Equivalent | MEDICAL LASER SYSTEMS INC |
| K080786 | ML830TP | Oct 03, 2008 | Substantially Equivalent | MICROLIGHT CORPORATION OF AMERICA |
| K082707 | MEDX LPT 200 TETHERED LASER & MEDX LPS 200 (ORALASE) PORTABLE LASER | Oct 01, 2008 | Substantially Equivalent | MEDX ELECTRONICS, INC. |
| K080102 | TQ SOLO AND SOLO PRO AND LS50 ACCESSORY AND MR4 MULTI RADIANCE THERAPY SYSTEM | Aug 20, 2008 | Substantially Equivalent | ESCADA INTERNATIONAL, INC. |
| K073352 | WEBERNEEDLE BASIC LASER | Aug 11, 2008 | Substantially Equivalent | WEBER MEDICAL GMBH |
| K080465 | WS FAR INFRARED THERAPY UNIT, MODEL # TY-101 SERIES | Jul 18, 2008 | Substantially Equivalent | WS FAR IR MEDICAL TECHNOLOGY CO., LTD. |
| K080689 | SPECTRA THERAPY SYSTEM A1000 LASER DEVICE | Jul 09, 2008 | Substantially Equivalent | PREMIER DYNAMICS, INC. |
| K072399 | DEL SOL RED LIGHT THERAPY SYSTEM | May 23, 2008 | Substantially Equivalent | EDGE SYSTEMS, INC. |
| K080084 | CELL GEN LASER, MODEL CG-4000 | Apr 21, 2008 | Substantially Equivalent | CELL GEN THERAPEUTICS, LLC |
| K080318 | ALMA LASER NIR MODULE | Mar 07, 2008 | Substantially Equivalent | ALMA LASERS LTD. |
| K072048 | LUMACARE MODEL LC-122M NON-COHERENT LIGHT SOURCE AND MODEL LUM-P FIBRE OPTIC PROBE | Nov 16, 2007 | Substantially Equivalent | LYNTON LASERS LIMITED |
| K070690 | THE LIFE VESSEL | Nov 16, 2007 | Substantially Equivalent | COTTONWOOD VESSEL CORPORATION |
| K071445 | TERRAQUANT MQ2000 V.5 WITH THE TQ-1TENS | Oct 29, 2007 | Substantially Equivalent | ESCADA INTERNATIONAL, INC. |
| K070338 | RAINBOW, RAINBOW LIGHT,RAINBOW BLUE, RAINBOW PLUS | Aug 28, 2007 | Substantially Equivalent | RAINBOW COMMUNICATIONS, INC |
| K070516 | POWERLASER | Jul 02, 2007 | Substantially Equivalent | POWERMEDIC APS |
| K070974 | LIGHT RELIEF, MODEL LR150, LR200 | May 24, 2007 | Substantially Equivalent | LIGHT RELIEF, LLC |
| K070024 | THOR VR SINGLE DIODE LASER TREATMENT PROBE, MODEL 200 MW SINGLE VR DIODE PROBE | May 16, 2007 | Substantially Equivalent | THOR INTERNATIONAL |
| K063745 | MEDILASER, MODEL 1000 | Apr 23, 2007 | Substantially Equivalent | LASER THERA, LLC |
| K063568 | HWATO TDP HEAT LAMP, MODELS TDP11-DL, TDP12-XL AND TDP-22XL | Mar 22, 2007 | Substantially Equivalent | SUZHOU MEDICAL APPLIANCE FACTORY |
| K070400 | LC THERAPY, MODEL LCT-1000 | Feb 28, 2007 | Substantially Equivalent | LITECURE, LLC |
| K062635 | MODEL 2200 | Dec 19, 2006 | Substantially Equivalent | CLARIMEDEX, INC. |
| K060792 | ILLUMIMED | Dec 01, 2006 | Substantially Equivalent | PHOTOACTIF, LLC |
| K061614 | TERRAQUANT MQ2000 V. 5 AND HANDYRX MQ2007 LASERS | Oct 06, 2006 | Substantially Equivalent | ESCADA INTERNATIONAL, INC. |
| K060153 | ACUMED LASER, MODEL 1000 | Sep 29, 2006 | Substantially Equivalent | LASER THERA, LLC |
| K052492 | AIRNERGY+STREAM | Sep 05, 2006 | Substantially Equivalent | NATURAL ENERGY SOLUTIONS AG |
| K060191 | ACP OMNIPAD LIGHT THERAPY SYSTEM & ACP OMNIPAD 500 CONTROL UNIT | Jul 12, 2006 | Substantially Equivalent | ACCELERATED CARE PLUS CORP. |
| K061080 | IR PRO 250 | Jun 14, 2006 | Substantially Equivalent | LHASA OMS, INC. |
| K060134 | APOLLO IR HEAT LAMP SYSTEM | Mar 21, 2006 | Substantially Equivalent | APOLLO PHYSICAL THERAPY PRODUCTS INTERNATIONAL |
| K051875 | BIOFLEX PRESCRIPTION SYSTEM AND RELATED TREATMENT HEADS | Mar 13, 2006 | Substantially Equivalent | MEDITECH INTERNATIONAL, INC. |
| K053376 | CHUNG CHENG FAR INFRARED RAY HEALTHFUL LAMP (OR MEDICAL FIR RADIATOR), MODEL CH-8810 | Feb 16, 2006 | Substantially Equivalent | CHUNG CHENG ELECTRIC HEATING CO., LTD. |
| K051961 | WWMED, MODEL 401 | Feb 10, 2006 | Substantially Equivalent | WONG WAY CORPORATION |
| K053473 | MAESTRO MDTL LASER SYSTEM | Feb 03, 2006 | Substantially Equivalent | ADVANCED MEDICAL TECHNOLOGIES, INC. |
| K052307 | BEAMER PAINLOW INFRARED LIGHT TREATMENT SYSTEM | Dec 16, 2005 | Substantially Equivalent | BEAMLINE CORPORATION |
| K053201 | CURAE'LASE CL1000 IR LASER SYSTEM | Dec 09, 2005 | Substantially Equivalent | CURAE'LASE INC. |
| K052814 | LUMINA 1600, 3300 AND 6600 SYSTEMS | Nov 30, 2005 | Substantially Equivalent | USA LASER BIOTECH INC. |
| K052647 | CLINI-LASE SYSTEM, MODELS CL-BASE, CL-2000, CL-1200, CL-500, CL-300, CL-275, CL-155, CL-55, CLP-BASE, CLP-275, CLP-55. | Nov 09, 2005 | Substantially Equivalent | AMERICAN SPINE CENTER, LTD. |
| K051548 | IRRADIA MID - LASER (S3) | Oct 24, 2005 | Substantially Equivalent | IRRADIA AB |
| K051680 | DYNATRON DX2 TRACTION UNIT | Oct 11, 2005 | Substantially Equivalent | DYNATRONICS CORP. |
| K052063 | HUANQIU HEATING LAMP | Sep 30, 2005 | Substantially Equivalent | A & A MEDICAL SUPPLIES INC |
| K051537 | HILT FAMILY LASER: HILT I, HILT II, HILT III | Sep 26, 2005 | Substantially Equivalent | CYNOSURE, INC. |
| K051922 | ASA 'M FAMILY' DIODE LASER, MODEL MI, MIX5, M6 | Sep 14, 2005 | Substantially Equivalent | CYNOSURE, INC. |
| K051816 | LUMIWAVE 1X4 INFRARED THERAPY DEVICE | Aug 26, 2005 | Substantially Equivalent | BIOCARE SYSTEMS, INC. |
| K051681 | DERMILLUME RED, MODEL HR1000 | Jul 27, 2005 | Substantially Equivalent | CARE ELECTRONICS, INC. |
| K051261 | DYNATRON X3 , DYNATRON XP IR LIGHT PAD, D405 IR LIGHT PROBE | Jul 25, 2005 | Substantially Equivalent | DYNATRONICS CORP. |
| K043055 | TERRAQUANT MQ2000 LASER THERAPY DEVICE | Jul 25, 2005 | Substantially Equivalent | ESCADA INTERNATIONAL, INC. |
| K050370 | PALOMAR LUXIR HANDPIECE | Jun 15, 2005 | Substantially Equivalent | PALOMAR MEDICAL TECHNOLOGIES, INC. |
| K043558 | XINFENG HEAT LAMPS, MODELS, CQ-27,CQ-36, CQ-55, CQ-55A | Jun 06, 2005 | Substantially Equivalent | CHONGQING XINFENG MEDICAL INSTRUMENTS CO., LTD. |
| K043306 | SKYLARK INFRARED PHOTON STIMULATOR, MODELS, SD-956IR AND SD-100IR | Jun 06, 2005 | Substantially Equivalent | SKYLARK DEVICE & SYSTEMS CO., LTD |
| K051046 | PAINACEA MODEL XR8 INFRARED HEAT LAMP | May 10, 2005 | Substantially Equivalent | ATLANTIS LUMINESCENT PRODUCTS, LLC |
| K043586 | LASER SYS*STIM 540, MODEL ME 540 | May 06, 2005 | Substantially Equivalent | METTLER ELECTRONICS CORP. |
| K050022 | MEDX HOME | May 05, 2005 | Substantially Equivalent | MEDX ELECTRONICS, INC. |
| K050070 | K-LASER, MODELS 3,4,4D,6D | Mar 25, 2005 | Substantially Equivalent | ELTECH, S.R.L. |
| K043317 | OMNILUX PLUS | Mar 15, 2005 | Substantially Equivalent | PHOTO THERAPEUTICS LIMITED |
| K042813 | BIOBEAM NARROW BAND LIGHT THERAPY DEVICES | Feb 25, 2005 | Substantially Equivalent | LIFE WITHOUT PAIN, LLC |
| K041885 | BIOFLEX LD-175 AND LD-1200 TREATMENT HEADS | Feb 24, 2005 | Substantially Equivalent | MEDITECH INTERNATIONAL, INC. |
| K041679 | COLD LIGHT; COLD LIGHT MD; GOSSAMER DERMLIGHT | Dec 16, 2004 | Substantially Equivalent | ONYX MEDICAL INC. |
| K042532 | BIOCARE SYSTEMS PREMIR 818 | Dec 13, 2004 | Substantially Equivalent | BIOCARE SYSTEMS, INC. |
| K041364 | ML830 LASER SYSTEM | Dec 13, 2004 | Substantially Equivalent | MICROLIGHT CORPORATION OF AMERICA |
| K030275 | MB SYSTEM, BIOENERGY LIGHT THERAPY | Nov 29, 2004 | Substantially Equivalent | AMEST CORP. |
| K042256 | IR HEAT LAMP SYSTEMS: ICL 15 HFPL SYSTEM, ICL 60 PLUS HFPL SYSTEM (MODELS 40, 100 AND 250), ICL 100 ACTIVO SCANNER SYSTE | Nov 17, 2004 | Substantially Equivalent | USA LASER BIOTECH INC. |
| K042165 | CUTERA TABLETOP AESTHETIC PRODUCT | Oct 18, 2004 | Substantially Equivalent | CUTERA, INC. |
| K040662 | VECTRA GENISYS (MODULE & TRANSPORTABLE) AND INTELECT XT (MODULE & TRANSPORTABLE) LASER SYSTEMS | Sep 08, 2004 | Substantially Equivalent | CHATTANOOGA GROUP |
| K040729 | SOLARIS D890 THERAPY PROBE | Jun 02, 2004 | Substantially Equivalent | DYNATRONICS CORP. |
| K040664 | OMNILIGHT VL-2004, PL-2004, DL-2004, AND WL-2004 | May 28, 2004 | Substantially Equivalent | OMNILIGHT, INC. |
| K040679 | RICH-MAR AUTOPRISM INFRARED LAMP | May 07, 2004 | Substantially Equivalent | RICH-MAR CORP. |
| K033986 | MLT-1000 IR LASER SYSTEM | Mar 29, 2004 | Substantially Equivalent | MEDICAL LASER THERAPEUTICS LP |
| K033923 | TH0R DDII IR LAMP SYSTEM | Mar 17, 2004 | Substantially Equivalent | THOR INTL. |
| K033555 | KENKOWAVE INFRARED PAIN TREATMENT SYSTEM | Mar 02, 2004 | Substantially Equivalent | KAYLIGHT CORPORATION |
| K033768 | ALTUS MEDICAL OPTIONAL INFRARED HANDPIECE | Feb 17, 2004 | Substantially Equivalent | ALTUS MEDICAL, INC. |
| K031612 | ALT LASER, MODEL VTR 75 | Dec 11, 2003 | Substantially Equivalent | AVICENNA LASER TECHNOLOGY, INC. |
| K024027 | LIGHTWAVE INFRARED LAMPS LW10D AND LW30D | Dec 03, 2003 | Substantially Equivalent | SKYTECH ENTERPRISES, INC. |
| K033035 | TLC MODELS ULK-H AND ULT-H INFRARED LAMPS | Nov 20, 2003 | Substantially Equivalent | TLC MARKETING, INC. |
| K032787 | NEUROLASE, MODELS 150V, 150C, 1064 | Nov 20, 2003 | Substantially Equivalent | SPECTRUM LASER & TECHNOLOGIES |
| K032379 | QUASAR, MODEL MD21 | Nov 20, 2003 | Substantially Equivalent | QUANTUM SKINCARE, INC. |
| K024361 | EM PROBE, EM PAD | Oct 09, 2003 | Substantially Equivalent | EM PROBE INC. |
| K032231 | MEDX1100 CONSOLE & MEDX 100T AND DUOLIGHT LASER ACCESSORIES, MEDX 100 PORTABLE LASER | Oct 03, 2003 | Substantially Equivalent | MEDX ELECTRONICS, INC. |
| K032229 | QUANTUM WARP 10 LIGHT DELIVERY SYSTEM | Sep 12, 2003 | Substantially Equivalent | QUANTUM DEVICES, INC. |
| K024179 | PALOMAR LIGHTCUBE | Jun 04, 2003 | Substantially Equivalent | PALOMAR MEDICAL PRODUCTS, INC. |
| K023621 | BIOFLEX PROFESSIONAL THERAPY SYSTEM | Apr 10, 2003 | Substantially Equivalent | MEDITECH INTERNATIONAL, INC. |
| K022609 | SURGICAL PATIENT WARMER, MODEL PW820 JHU | Mar 06, 2003 | Substantially Equivalent | FISHER & PAYKEL HEALTHCARE, LTD. |
| K022888 | ACUBEAM, SUPER NOVA, DIO | Dec 11, 2002 | Substantially Equivalent | LIGHT FORCE THERAPY, INC. |
| K020851 | TDP HEAT LAMP OR INFRARED HEATING LAMP, MODELS CQG-S1, CQG-111A/B, CQG-222A/B, CQG-270A/B, CQG-222D | Sep 23, 2002 | Substantially Equivalent | C&H INTERNATIONAL |
| K020464 | SANIDAD FAR-INFRARED MINI LAMP, MODEL FI-3646 | Sep 17, 2002 | Substantially Equivalent | ROLOR ELECTRONICS CORP. |
| K020462 | SANIDAD THERMAL FAR-INFRARED WAVE LAMP, MODEL AP-2018 | Sep 16, 2002 | Substantially Equivalent | ROLOR ELECTRONICS CORP. |
| K013197 | WS-501 HEAT LAMP | Aug 29, 2002 | Substantially Equivalent | LHASA MEDICAL, INC. |
| K021956 | MHS MED LIGHT 1000 | Aug 13, 2002 | Substantially Equivalent | MICRO HEALTH SYSTEMS INC. |
| K020017 | MEDX 1000 SERIES | Jul 12, 2002 | Substantially Equivalent | MEDX ELECTRONICS, INC. |
| K014208 | SSIR SYSTEM | Jul 02, 2002 | Substantially Equivalent | RUSSIAN-AMERICAN TECHNOLOGY ASSOCIATES, INC. |
| K011355 | BIOLIGHT PCD | Jan 17, 2002 | Substantially Equivalent | BIOLIGHT INTERNATIONAL AB |
| K012508 | MU PHOTONICS PAIN THERAPIST | Oct 09, 2001 | Substantially Equivalent | NU PHOTONICS, INC. |
| K003538 | TDP CQ-27 HEAT LAMP | Jun 04, 2001 | Substantially Equivalent | LHASA MEDICAL, INC. |
| K001179 | SUPER NOVA, ACUBEAM | Oct 27, 2000 | Substantially Equivalent | LIGHT FORCE THERAPY, INC. |
| K001056 | OLYMPIC WARM-UP | Sep 29, 2000 | Substantially Equivalent | OLYMPIC MEDICAL CORP. |
| K993684 | SPINAL PAD | Jul 19, 2000 | Substantially Equivalent | BIOSCAN, INC. |
| K993686 | LIGHT PATCH | Jul 18, 2000 | Substantially Equivalent | BIOSCAN, INC. |
| K993685 | BIOPACK | Jul 18, 2000 | Substantially Equivalent | BIOSCAN, INC. |
| K993123 | QK-WIDE BAND SPECTRUM THERAPEUTIC APPARATUS, MODELS CO1A, CO1B, CO1C, CO1D, CO2A, CO2B | Dec 17, 1999 | Substantially Equivalent | UNITED PACIFIC CO., LTD. |
| K990233 | ST-302 INFRAREX | Oct 27, 1999 | Substantially Equivalent | SKYLARK DEVICE CO., LTD. |
| K991503 | SACRED CRANE TDP LAMP, MODELS CQ-27, CQ-12, CQ-36 | Jul 28, 1999 | Substantially Equivalent | UNITED PACIFIC CO., LTD. |
| K982636 | PATIENT WARMER- MODEL PW810 | Oct 26, 1998 | Substantially Equivalent | FISHER & PAYKEL HEALTHCARE, LTD. |
| K982546 | PHASER-2000 | Sep 22, 1998 | Substantially Equivalent | DIOMEDICS, INC. |
| K974468 | PHOTONIC STIMULATOR | Jun 22, 1998 | Substantially Equivalent | BALES SCIENTIFIC, INC. |
| K980607 | DERMATHERM 100 | Apr 03, 1998 | Substantially Equivalent | NEW STAR LASERS, INC. |
| K964397 | THERAPIK | Nov 04, 1997 | Substantially Equivalent | THE JENEX CORPORATION |
| K970592 | N/A | Jun 13, 1997 | Substantially Equivalent | NORTH AMERICAN TECHNICAL SERVICES CORP. |
| K970590 | N/A | Jun 13, 1997 | Substantially Equivalent | NORTH AMERICAN TECHNICAL SERVICES CORP. |
| K954577 | WS FREQUENCY SPECTRUM EFFECT PHYSIATRICS APPARATUS | May 09, 1997 | Substantially Equivalent | C.A.I. INDUSTRIES CORP. |
| K963728 | THE SPECIAL ELECTROMAGNETIC THERAPEUTIC APPARATUS | Dec 12, 1996 | Substantially Equivalent | CHINA CHONGQING BASHAN INSTRUMENT FACTORY |
| K960036 | FIRARD II/ TDP LAMP | Jun 06, 1996 | Substantially Equivalent | HELIO MEDICAL SUPPLIES, INC. |
| K941675 | TDP THE SPECIAL ELECTROMAGNETIC THERAPEUTIC APPARATUS | Mar 27, 1995 | Substantially Equivalent | C.M.D. ACUPUNCTURE CENTER & HERBS STORE |
| K935982 | SPECIAL ELECTROMAGNETIC THERAPEUTIC APPARATUS | Mar 24, 1995 | Substantially Equivalent | C.M.D. ACUPUNCTURE CENTER |
| K935995 | HAND-HELD HEAT APPLICATOR | Jun 09, 1994 | Substantially Equivalent for Some Indications | AVON PRODUCTS, INC. |
| K931261 | SPECTROPAD SYSTEM | Mar 31, 1994 | Substantially Equivalent | SMI |
| K933584 | SACRED CRANE TDP | Jan 27, 1994 | Substantially Equivalent | TELSTAR INNOVATIONS, INC. |
| K932881 | OLYMPIC WARM-LAMP | Jan 26, 1994 | Substantially Equivalent | OLYMPIC MEDICAL CORP. |
| K925054 | INFRARED LAMP | Jun 29, 1993 | Substantially Equivalent | LUMISCOPE CO., INC. |
| K923254 | THERABEAM INFRARED HEAT LAMP | Feb 23, 1993 | Substantially Equivalent | STRATEGIC ALLIANCES CORP. |
| K922900 | INFRARED LAMP | Nov 24, 1992 | Substantially Equivalent | HARRIER, INC. |
| K913973 | INFRARED HEAT LAMPS & MASSAGER MODEL NH-213 | Nov 29, 1991 | Substantially Equivalent | NATIONAL HEALTH-CARE EQUIPMENT, INC. |
| K913880 | INFRARED HEAT LAMP MODEL NH-202 | Nov 29, 1991 | Substantially Equivalent | NATIONAL HEALTH-CARE EQUIPMENT, INC. |
| K913856 | INFRARED HEAT LAMP MODEL NH-201 | Nov 29, 1991 | Substantially Equivalent | NATIONAL HEALTH-CARE EQUIPMENT, INC. |
| K902803 | A PHYSIOTHERAPY APPARATUS | Feb 06, 1991 | Substantially Equivalent | GRACE RIVER ENT., INC. |
| K900384 | INFRAVIB MASSAGER - MODEL PR-1000 | Feb 27, 1990 | Substantially Equivalent | INFRALUX INTERNATIONAL, INC. |
| K890586 | INFRARED DELUXE | Aug 22, 1989 | Substantially Equivalent | HEALTHTEAM |
| K890585 | INFRARED HEX | Aug 22, 1989 | Substantially Equivalent | HEALTHTEAM |
| K890556 | TDP INFRARED HEAT LAMP | Jun 09, 1989 | Substantially Equivalent | TOXICOLOGY PROFESSIONALS, INC. |
| K875052 | TDP, LARK BRAND AND MIT LAMP | Jun 23, 1988 | Substantially Equivalent | I.E.C. CO. |
| K871179 | OPN XII UL | Apr 13, 1987 | Substantially Equivalent | ARAGONA AB CO. |
| K864714 | INFRALUX HEAT LAMP | Mar 12, 1987 | Substantially Equivalent for Some Indications | INFRALUX INTERNATIONAL, INC. |
| K854151 | HOMECARE CLINICS INFRAHEAT #230 | Jan 30, 1986 | Substantially Equivalent | NELKIN/PIPER INTL. |
| K850852 | INFRARAX DEVICE | Aug 21, 1985 | Substantially Equivalent | MEDICON, INC. |
FEI Numbers
This FDA classification entry is associated with 423 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 423 registration numbers. Click on an entry to view related FDA registrations.