FDA Product Code
FDA Product Code ILY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Physical Medicine
- 21 CFR Citation
- 890.5500
510(k) Clearances — 229 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253965 | CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.) | Wuhan PHOMED Technology Company , Ltd. | 2026-03-19 | Traditional | PDF ↗ |
| K242755 | Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B) | Gigaalaser Company , Ltd. | 2025-05-19 | Traditional | PDF ↗ |
| K231997 | SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) | Cure Point Therapeutics, Inc. | 2024-10-15 | Traditional | PDF ↗ |
| K223642 | LED Lip Perfector, model: ZC-05 | Light Tree Ventures Europe B.V. | 2023-03-09 | Traditional | PDF ↗ |
| K221189 | OLIZ LTB-1000A | Ltbio Co., Ltd. | 2022-08-29 | Traditional | PDF ↗ |
| K213524 | CytonPro-5000 | Cytonsys, Inc. | 2022-08-10 | Traditional | PDF ↗ |
| K202028 | dermalux Flex MD | Aesthetic Technology, Ltd. | 2020-12-16 | Traditional | PDF ↗ |
| K171087 | AXON IR Heat Lamp | Crystal Medtech, LLC | 2017-07-07 | Traditional | PDF ↗ |
| K163079 | HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System | Healthlight, LLC | 2017-06-13 | Traditional | PDF ↗ |
| K170068 | Softcure 96 | Wellray Medical Laser, Inc. | 2017-05-05 | Traditional | PDF ↗ |
| K162590 | Bashan TDP Heat Lamp | Chogqing Yuhe Medical Instruments Co., Ltd. | 2017-02-14 | Traditional | PDF ↗ |
| K162763 | Vevazz LED Heat Lamp | Vevazz, LLC | 2017-01-05 | Traditional | PDF ↗ |
| K160849 | WS(TM) Far-Infrared Therapy Unit, Model KP-B210 | Ws Far IR Medical Technology Co., Ltd. | 2016-12-15 | Traditional | PDF ↗ |
| K152087 | HeatLux Pro II | Home Skinovations , Ltd. | 2016-07-29 | Traditional | PDF ↗ |
| K161198 | Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 | Usa Laser Biotech, Inc. | 2016-07-26 | Traditional | PDF ↗ |
| K152461 | The Time Machine Series Lasers | Medical Lasers Manufacturer, Inc. | 2016-07-08 | Traditional | PDF ↗ |
| K153399 | LightStim Professional LED Bed | Led Intellectual Properties, LLC | 2016-07-05 | Traditional | PDF ↗ |
| 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 | Usa Laser Biotech, Inc. | 2016-07-05 | Traditional | PDF ↗ |
| K153389 | Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom) | In Light Wellness Systems, Inc. | 2016-03-30 | Traditional | PDF ↗ |
| K152280 | BioPhotas Celluma3 | Biophotas, Inc. | 2016-03-02 | Traditional | PDF ↗ |
| K150716 | Varaya Sport | Varaya Photoceuticals, LLC | 2015-12-08 | Traditional | PDF ↗ |
| K150554 | NuBrilliance Light Pain Therapy | Wellquest International, Inc. | 2015-10-06 | Traditional | PDF ↗ |
| K151521 | Phoenix Thera-Lase System | Phoenix Thera-Lase Systems, LLC | 2015-09-04 | Traditional | PDF ↗ |
| K151333 | LightStim for Pain LED Belt | Led Intellectual Properties, LLC | 2015-08-21 | Traditional | PDF ↗ |
| K150466 | ZX2 Laser System | Lzr7, Inc. | 2015-06-08 | Traditional | PDF ↗ |
| K150175 | HeatLux Pro I | Home Skinovations , Ltd. | 2015-03-31 | Special | PDF ↗ |
| K141892 | QK-SYSTEMIC THERAPEUTIC APPARATUS | Harbin Quanke Medi-Technical Development Co., Ltd. | 2015-01-28 | Traditional | PDF ↗ |
| K142025 | NEUROLUMEN PN-1000 | Neurolumen, LLC | 2015-01-21 | Traditional | PDF ↗ |
| K142722 | 3B Laser 500, 3B Laser 200, LA-X P 500, LA-X P 200 | Livetec GmbH | 2015-01-13 | Traditional | PDF ↗ |
| K141861 | HILTHERA 4.0 | Jeisys Medical, Inc. | 2015-01-07 | Traditional | PDF ↗ |
| K142256 | Applied BioPhotonics Phototherapy System ABPT1003 | Applied Biophotonics , Ltd. | 2015-01-07 | Traditional | PDF ↗ |
| K142340 | Infrared Therapy System | Beijing Huatai Healthcare Technology Co., Ltd. | 2014-12-02 | Traditional | PDF ↗ |
| K142215 | Power Twin21-50/Power Twin21-100 | Livetec GmbH | 2014-11-07 | Traditional | PDF ↗ |
| K142078 | VELASII THERAPY LASER SYSTEM | Aspen Laser Systems, LLC | 2014-10-30 | Traditional | PDF ↗ |
| K141564 | OPTON PRO | Zimmer Medizinsystems GmbH | 2014-10-24 | Traditional | PDF ↗ |
| K140865 | INFRARED HEATING DEVICE | Pro Medical Supplies, Inc. | 2014-09-03 | Traditional | PDF ↗ |
| K131080 | PHYSIOLASER OLYMPIC, SINGLE PROBES CW, CLUSTER PROBES CW, LIGHT NEEDLE, PHOTONIC SATELLITE | Reimers and Janssen GmbH | 2014-06-13 | Traditional | PDF ↗ |
| K132016 | LUMIX 3 PLUS AND LUMIX 3 ULTRA SYSTEM | Texas Applied Biomedical Services, Inc. | 2014-06-02 | Traditional | PDF ↗ |
| K132529 | GALLIEON-1 MEDICAL LASER | Future Device and Technology, Inc. | 2014-05-12 | Traditional | PDF ↗ |
| K134017 | GIGALASER | Powermedic Aps | 2014-05-02 | Traditional | PDF ↗ |
| K131113 | BIOPHOTAS CELLUMA | Biophotas, Inc. | 2014-01-15 | Traditional | PDF ↗ |
| K130168 | CL10009 IR LASER | Curae'Lase, Inc. | 2014-01-10 | Traditional | PDF ↗ |
| K131259 | LASER-STIM | Shenzhen Dongdixin Technology Co., Ltd. | 2013-12-27 | Traditional | PDF ↗ |
| K123474 | AVANT LASER | Avant Wellness Systems, LLC | 2013-12-03 | Abbreviated | PDF ↗ |
| K130866 | BIOLIGHT BIODYNAM | Biolight AB | 2013-10-25 | Special | PDF ↗ |
| K131797 | 3B LASER NEEDLE | Livetec GmbH | 2013-10-10 | Traditional | PDF ↗ |
| K123177 | STIMLASE 2000 LOW LEVEL LASER THERAPY SYSTEM | Laserstim, Inc. | 2013-07-03 | Traditional | PDF ↗ |
| K123971 | CYNOSURE 1064NM DIODE LASER | Cynosure, Inc. | 2013-05-02 | Traditional | PDF ↗ |
| K121401 | TENDER TOUCH | Sometech Corporation | 2013-05-01 | Traditional | PDF ↗ |
| K122125 | ASA LASER SH1 | El.En Electronic Engineering Spa | 2013-01-25 | Traditional | PDF ↗ |
| K122237 | BIOPHOTAS LIFELIGHT | Biophotas, Inc. | 2013-01-03 | Traditional | PDF ↗ |
| K121363 | DIOWAVE LOW LEVEL COLD LASER SYSTEM | Technological Medical Advancments, Inc. (Tma) | 2012-11-23 | Traditional | PDF ↗ |
| K110558 | CS1000 LIGHT THERAPY DEVICE | Genesis Health Light Corporation | 2012-07-12 | Traditional | PDF ↗ |
| K120582 | HEATLUX | Home Skinovations , Ltd. | 2012-07-06 | Traditional | PDF ↗ |
| K113668 | HEALITE II SYSTEM | Lutronic Corporation | 2012-06-19 | Traditional | PDF ↗ |
| K121487 | LITECURE THERAPY COMPACT | Litecure, LLC | 2012-06-12 | Special | PDF ↗ |
| K120604 | K-LASER | Eltech S.R.L | 2012-05-25 | Traditional | PDF ↗ |
| K112494 | VARAYA AR , VARAYA SPORT | Varaya Photoceuticals, LLC | 2012-05-16 | Traditional | PDF ↗ |
| K120254 | THERASAGE HEATING PAD | Therasage Corporation | 2012-03-06 | Traditional | PDF ↗ |
| K113231 | WARP10,WARP75 | Quantum Devices, Inc. | 2012-02-27 | Traditional | PDF ↗ |
| K112016 | L-SER KO LAMP | Ya-Man, Ltd. | 2012-02-10 | Traditional | PDF ↗ |
| K113250 | DYNATRON TRI-WAVE LIGHT PAD DYNATRON TRI-WAVE LIGHT PROBE | Dynatronics Corp. | 2012-02-09 | Traditional | PDF ↗ |
| K111901 | ASA 'MPHI FAMILY DIODE LASER | Cynosure, Inc. | 2011-11-09 | Special | PDF ↗ |
| K110342 | YOLO CURVE | Yolo Medical, Inc. | 2011-08-22 | Traditional | PDF ↗ |
| K110721 | GAUNYING INFRARED LAMP | Foshan Gaunying Electronics Co., Ltd. | 2011-03-30 | Traditional | PDF ↗ |
| K102375 | LUCIA | Meridian Co., Ltd. | 2011-02-25 | Traditional | PDF ↗ |
| K101893 | NEXUS BIOWAVE 7W LITE IR LAMP SYSTEM, NEXUS BIOWAVE 10W LITE IR LAMP SYSTEM, NEXUS BIOWAVE 30W PRO IR LAMP SYSTEM, NEXUS | Usa Laser Biotech, Inc. | 2011-02-17 | Traditional | PDF ↗ |
| K103511 | LITECURE THERAPY SYSTEM | Litecure, LLC | 2011-01-25 | Special | PDF ↗ |
| K101894 | HEALTHLIGHT MICROCONTROLLER, MINIPRO, PRONEUROLIGHT, AND PRO UNIT | Bioremedi Therapeutic Systems, Inc. | 2011-01-21 | Traditional | PDF ↗ |
| K101716 | HVR PAIN RELIEF DEVICE | H.V.R., Inc. | 2011-01-11 | Traditional | PDF ↗ |
| K101693 | GAUNYING INFRARED LAMP MODEL IL50 | Foshan Gaunying Electronics Co., Ltd. | 2011-01-05 | Traditional | PDF ↗ |
| K102134 | MODEL LA-1200 MULTI-CHANNEL LASER THERAPY SYSTEM | United Integrated Services Co., Ltd. | 2010-12-23 | Traditional | PDF ↗ |
| K101267 | PREMIO 10 MOXA | Sedatelec | 2010-12-03 | Traditional | PDF ↗ |
| K100213 | LUMANOSITY CELEBRITY, MODEL 204 | Lumanosity, Inc. | 2010-10-04 | Traditional | PDF ↗ |
| K093204 | INNOVATIVE MED MULTI WAVE LIGHT THERAPY SYSTEM | Innovative Med, Inc. | 2010-08-23 | Traditional | PDF ↗ |
| K102149 | GAUNYING INFRARED LAMP | Foshan Gaunying Electronics Co., Ltd. | 2010-08-13 | Traditional | PDF ↗ |
| K101227 | BACK-TEK | York Biomedical, Inc. | 2010-06-23 | Traditional | PDF ↗ |
| K090250 | ELECTRO-LIGHT THERAPY | Hill Laboratories Co. | 2010-02-11 | Traditional | PDF ↗ |
| K092589 | THERMOTEX PLATINUM SYSTEM | Eas Consulting Group, LLC | 2010-01-28 | Traditional | PDF ↗ |
| K091675 | LASERPEN PRACTISE AND EXPERT, HANDYLASER SPRINT, HANDYLASER TRION, PHYSIOLASER OLYMPIC, POLYLASER | Reimers and Janssen GmbH | 2009-12-15 | Traditional | PDF ↗ |
| K091726 | NEXUS XPULSE 805 IR LAMP SYSTEM, NEXUS XPULSE 980 IR LAMP SYSTEM, MODEL 805, 980 | Usa Laser Biotech, Inc. | 2009-10-28 | Traditional | PDF ↗ |
| K090008 | TANDA RESTORE, MODEL PTSCS | Pharos Life Corporation | 2009-10-15 | Traditional | PDF ↗ |
| K092222 | THERMAPULSE | Palomar Medical Products, Inc. | 2009-08-20 | Special | PDF ↗ |
| K091497 | K-LASER K-1200, MODEL 12 W | Eltech S.R.L | 2009-08-19 | Traditional | PDF ↗ |
| K091158 | SCALAR WAVE LASER SYSTEM | Stellar Lasers | 2009-08-10 | Traditional | PDF ↗ |
| K091285 | AL T LASER, MODEL AVI HPLL-12 | Avicenna Laser Technology, Inc. | 2009-07-28 | Traditional | PDF ↗ |
| K083183 | AKLARUS PHOTOTHERAPY SYSTEM | Hill Laboratories Co. | 2009-07-16 | Traditional | PDF ↗ |
| K083580 | ANTI-WRINKLE LIGHT, MODEL 1302 AND PAIN THERAPY LIGHT, MODEL 1301 | Led Intellectual Properties, LLC | 2009-06-22 | Traditional | PDF ↗ |
| K081720 | PRECISION TDP, HEAT AND INFRARED LAMPS AND MARVEL AND WONDER LAMPS | Prime Herbs Corporation | 2009-06-16 | Traditional | PDF ↗ |
| K082686 | MULTI-CHANNEL LASER THERAPY SYSTEM | United Integrated Services Co., Ltd. | 2009-05-11 | Traditional | PDF ↗ |
| K082223 | NEUTROLUMENPN SYSTEM, MODEL 1000 | Neurolumen, LLC | 2009-04-21 | Traditional | PDF ↗ |
| K083595 | EZLASE | Biolase Technology, Inc. | 2009-04-14 | Traditional | PDF ↗ |
| K081962 | LAPEX BCS | Meridian Co., Ltd. | 2008-12-29 | Traditional | PDF ↗ |
| K081355 | BIOFLEX LD-R100 TREATMENT HEAD | Meditech International, Inc. | 2008-12-18 | Abbreviated | PDF ↗ |
| K083560 | EXPANDED SPECTRUM PHOTO THERAPY DEVICE, MODEL ESPT-3X | Lighthouse Technical Innovations, Inc. | 2008-12-11 | Traditional | PDF ↗ |
| K073681 | NANOBEAM 940, MODEL 940-900-02 | Davaray, Inc. | 2008-12-09 | Traditional | PDF ↗ |
| K081505 | THERAGEM PROFESSIONAL T1002 | Medica Health, Ltd. | 2008-11-19 | Traditional | PDF ↗ |
| K081570 | DPL THERAPY SYSTEM | Led Technologies, LLC | 2008-11-07 | Traditional | PDF ↗ |
| K082969 | LUMINEX INFRARED LAMP SYSTEM | Medical Laser Systems, Inc. | 2008-10-23 | Traditional | PDF ↗ |
| K080786 | ML830TP | Microlight Corporation of America | 2008-10-03 | Traditional | PDF ↗ |
Product code ILY · Class II · Physical Medicine. Data: openFDA.