510(k) submissions
All indexed GEX clearances · showing 401–450 of 667
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K193446 | Bare: 808Hair removal | Luvo Medical Technologies, Inc.Canada | Diode | Class 2 | 2020-03-10 |
| K193426 | Elite iQHair removal | Cynosure, LLCUnited States | Alexandrite | Class 2 | 2020-03-09 |
| K200234 | Surgical laser fibersSurgical cutting | Quanta System SpaItaly | Laser fiber / delivery | Class 2 | 2020-02-25 |
| K192600 | Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60Surgical cutting | Quanta System SpaItaly | Holmium (Ho:YAG) | Class 2 | 2020-02-21 |
| K192617 | Gemini 810+980 Soft Tissue LaserSurgical cutting | Azena Medical, LLCUnited States | Diode | Class 2 | 2020-02-20 |
| K192583 | PicoLazer Laser SystemPigment treatment | Rohrer AestheticsUnited States | Picosecond | Class 2 | 2020-01-17 |
| K193500 | Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemHair removal | Lumenis, Inc.Israel | IPL | Class 2 | 2020-01-16 |
| K193478 | XTRAC Momentum Excimer Laser SystemSkin resurfacing | Strata Skin Sciences, Inc.United States | Other | Class 2 | 2020-01-14 |
| K193375 | NeuroBlate SystemSurgical cutting | Monteris Medical,United States | Nd:YAG | Class 2 | 2020-01-03 |
| K191501 | PALLAS 308/311 Solid-State UV Laser SystemSkin resurfacing | Laseroptek Co., Ltd.Korea, Republic of | Other | Class 2 | 2020-01-03 |
| K192990 | Litho EvoSurgical cutting | Quanta System SpaItaly | Holmium (Ho:YAG) | Class 2 | 2019-12-20 |
| K192755 | Soli-Lite LG4 GalileoAcne treatment | Silhouet-Tone CorporationCanada | LED | Class 2 | 2019-12-20 |
| K192539 | Deka LuxeaHair removal | El.En Electronic Engineering SpaItaly | Diode | Class 2 | 2019-12-16 |
| K192569 | Diode Laser Therapy SystemHair removal | San HE Lefis Electronics Co., Ltd.China | Diode | Class 2 | 2019-12-13 |
| K192516 | Diode Laser 808nmHair removal | Beijing Superlaser Technology Co., Ltd.China | Diode | Class 2 | 2019-12-10 |
| K191962 | Vitra 2Ophthalmic | Quantel MedicalFrance | Nd:YAG | Class 2 | 2019-12-05 |
| K192430 | Epic 980Surgical cutting | Biolase, Inc.United States | Diode | Class 2 | 2019-12-04 |
| K192528 | CO2 Laser Therapy SystemSurgical cutting | Shangdong Huamei Technology Co., Ltd.China | CO2 | Class 2 | 2019-12-03 |
| K192269 | TwinScan 808/755 Laser SystemHair removal | Gme German Medical Engineering GmbHUnited States | Diode | Class 2 | 2019-11-19 |
| K192331 | LaseMD LEO Laser SystemPigment treatment | Lutronic GlobalUnited States | Thulium fiber | Class 2 | 2019-11-12 |
| K191693 | BC-5Vascular treatment | Reveallux, CorpUnited States | Other | Class 2 | 2019-11-01 |
| K191942 | MT One DiamondHair removal | M&T S.R.L.Italy | Diode | Class 2 | 2019-10-17 |
| K190319 | Waterlase Laser System FamilyDental | Biolase, Inc.United States | Er:YAG | Class 2 | 2019-10-10 |
| K191842 | Discovery Pico, Discovery Pico Plus, Discovery Pico DermPigment treatment | Quanta System SpaItaly | Q-Switched | Class 2 | 2019-09-17 |
| K191685 | PicoWay Laser SystemPigment treatment | Candela CorporationUnited States | Picosecond | Class 2 | 2019-09-16 |
| K191518 | CO2 Laser SystemSkin resurfacing | Shenzhen Gsd Tech Co., Ltd.China | CO2 | Class 2 | 2019-09-12 |
| K181614 | Sterling Supreme Diode LaserSurgical cutting | CAO Group, Inc.United States | Diode | Class 2 | 2019-09-10 |
| K181602 | Pioneer Elite Diode LaserSurgical cutting | CAO Group, Inc.United States | Diode | Class 2 | 2019-09-10 |
| K181601 | Precise SHP Diode LaserSurgical cutting | CAO Group, Inc.United States | Diode | Class 2 | 2019-09-09 |
| K192160 | EVO PlatformVascular treatment | Quanta System SpaItaly | Q-Switched | Class 2 | 2019-09-06 |
| K183563 | Holinwon 30Surgical cutting | Wontech Co., Ltd.Korea, Republic of | CO2 | Class 2 | 2019-09-05 |
| K191554 | LightWalker Laser System FamilySurgical cutting | Fotona D.O.O.Slovenia | Er:YAG | Class 2 | 2019-08-30 |
| K183122 | 810nm Diode Laser SystemHair removal | Shanghai Wonderful Opto-Electrics Tech.Co.,LtdChina | Diode | Class 2 | 2019-08-25 |
| K191349 | 980nm Diode Laser Therapy DeviceSurgical cutting | Shanghai Apolo Medical Technology Co., Ltd.China | Diode | Class 2 | 2019-08-16 |
| K183647 | SOLTIVE™ Laser System(SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Accessories)Surgical cutting | Olympus Surgical Technologies AmericaUnited States | Thulium fiber | Class 2 | 2019-08-09 |
| K191321 | Primelase ExcellenceHair removal | High Technology Products S.L.USpain | Diode | Class 2 | 2019-08-02 |
| K191611 | Diode Laser Therapy SystemsHair removal | Wingderm Electro-Optics , Ltd.China | Diode | Class 2 | 2019-07-31 |
| K182930 | PerioLase Nd:YAG Pulsed Dental Laser SystemSurgical cutting | Millennium Dental Technologies, Inc.United States | Nd:YAG | Class 2 | 2019-07-12 |
| K191162 | EpiLaze Multi-wavelength LaserHair removal | Rohrer AestheticsUnited States | Diode | Class 2 | 2019-07-09 |
| K190938 | Phototherapy SystemAcne treatment | Shanghai Apolo Medical Technology Co., Ltd.China | LED | Class 2 | 2019-06-26 |
| K190936 | Q-Switched Nd: YAG Laser SystemPigment treatment | Shanghai Apolo Medical Technology Co., Ltd.China | Nd:YAG | Class 2 | 2019-06-17 |
| K183566 | CLARITY II Laser SystemHair removal | Lutronic CorporationKorea, Republic of | Alexandrite | Class 2 | 2019-06-14 |
| K190542 | Soliton Acoustic Wave DevicePigment treatment | Soliton, Inc.United States | Nd:YAG | Class 2 | 2019-05-24 |
| K183199 | TRIO HandpieceSurgical cutting | Omniguide, Inc.United States | CO2 | Class 2 | 2019-05-02 |
| K183156 | V-LaserSurgical cutting | Wontech Co., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2019-04-24 |
| K182924 | Diode Laser Treatment SystemHair removal | Weifang KM Electronics Co., Ltd.China | Diode | Class 2 | 2019-04-15 |
| K190392 | WaveLight FS200 Patient InterfaceSurgical cutting | Alcon Laboratories, Inc.United States | Other | Class 2 | 2019-03-26 |
| K182173 | Joule SystemPigment treatment | Sciton, IncUnited States | Thulium fiber | Class 2 | 2019-03-06 |
| K190007 | Vydence Laser FamilyAcne treatment | Vydence Medical Industria E Comercio LtdaBrazil | Other | Class 2 | 2019-03-01 |
| K183452 | Vbeam Prima Laser SystemVascular treatment | Candela CorporationUnited States | Nd:YAG | Class 2 | 2019-02-01 |
