510(k) submissions
Filtered by Acne treatment · showing 51–84 of 84
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K213461 | AviClear Laser SystemAcne treatment | Cutera, Inc.United States | Other | Class 2 | 2022-03-24 |
| K212492 | Frax 1940 for Nordlys and Frax ProSkin resurfacing | Candela CorporationUnited States | Er:YAG | Class 2 | 2021-12-20 |
| K210847 | UltraClear Fractional Laser SystemSkin resurfacing | Fa International, LPUnited States | CO2 | Class 2 | 2021-12-10 |
| K202175 | OxyLight 2.0Acne treatment | Raja Trading Company, Inc.United States | LED | Class 2 | 2021-12-02 |
| K202998 | Vydence Zye and Vydence OneAcne treatment | Vydence Medical Industria E Comercio LtdaBrazil | Other | Class 2 | 2021-10-26 |
| K210535 | UltraLight LED SystemBody contouring | Rohrer AestheticsUnited States | LED | Class 2 | 2021-05-24 |
| K210925 | Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser FiberSurgical cutting | Boston Scientific CorporationUnited States | Laser fiber / delivery | Class 2 | 2021-04-28 |
| K202258 | ERISE Laser handpieceSkin resurfacing | El.En Electronic Engineering SpaItaly | Er:YAG | Class 2 | 2021-04-26 |
| K210226 | PicoSure WorkstationPigment treatment | Cynosure, LLCUnited States | Picosecond | Class 2 | 2021-03-30 |
| K203054 | FlexSysAcne treatment | Gme German Medical Engineering GmbHUnited States | Laser fiber / delivery | Class 2 | 2021-03-05 |
| K200693 | K2 MOBILESurgical cutting | Hulaser, Inc.Korea, Republic of | Diode | Class 2 | 2020-11-19 |
| K200104 | OxylightAcne treatment | Raja Trading Company, Inc.United States | LED | Class 2 | 2020-06-04 |
| K200751 | Photodynamic Therapy (PDT) EquipmentAcne treatment | Shangdong Huamei Technology Co., Ltd.China | LED | Class 2 | 2020-05-21 |
| K200659 | Dermalux Tri-Wave MDAcne treatment | Aesthetic Technology, Ltd.United Kingdom | LED | Class 2 | 2020-05-09 |
| 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 |
| K191693 | BC-5Vascular treatment | Reveallux, CorpUnited States | Other | Class 2 | 2019-11-01 |
| K191685 | PicoWay Laser SystemPigment treatment | Candela CorporationUnited States | Picosecond | Class 2 | 2019-09-16 |
| 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 |
| K190938 | Phototherapy SystemAcne treatment | Shanghai Apolo Medical Technology Co., Ltd.China | LED | Class 2 | 2019-06-26 |
| 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 |
| K173199 | PicoSure WorkstationPigment treatment | Cynosure, LLCUnited States | Picosecond | Class 2 | 2018-02-07 |
| K173002 | 2940 nm Er:Yag Laser HandpieceSkin resurfacing | Quanta System SpaItaly | Er:YAG | Class 2 | 2017-12-13 |
| K170187 | Photodynamic Therapy DeviceAcne treatment | Uvbiotek, LLCUnited States | Other | Class 2 | 2017-07-28 |
| K163197 | Cook Holmium Laser FiberSurgical cutting | Cook IncorporatedUnited States | Other | Class 2 | 2017-05-24 |
| K162851 | eLyx-PROAcne treatment | Intelligent Sensory Concept SASwitzerland | Other | Class 2 | 2017-01-24 |
| K162363 | V30 system, V-Form Handpiece BC Medium applicatorAcne treatment | Viora , Ltd.Israel | Other | Class 2 | 2016-11-18 |
| K160480 | PicoSure WorkstationPigment treatment | Cynosure, LLCUnited States | Picosecond | Class 2 | 2016-05-17 |
| K153229 | SuperbiumVascular treatment | Bios S.R.L.Italy | Nd:YAG | Class 2 | 2016-04-12 |
| K152611 | V20 systemAcne treatment | Viora , Ltd.Israel | Other | Class 2 | 2016-02-19 |
| K143713 | Lustre PRO Light SystemAcne treatment | Ambicare Health, Ltd.United Kingdom | Other | Class 2 | 2016-01-19 |
| K152714 | Quanta ForteHair removal | Quanta System SpaItaly | Diode | Class 2 | 2015-12-21 |
| K143105 | Picosure WorkstationPigment treatment | Cynosure, LLCUnited States | Picosecond | Class 2 | 2015-02-23 |