510(k) submissions
Filtered by Pigment treatment · showing 101–150 of 195
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K210535 | UltraLight LED SystemBody contouring | Rohrer AestheticsUnited States | LED | Class 2 | 2021-05-24 |
| K210964 | Resonic Rapid Acoustic Pulse DevicePigment treatment | Soliton, Inc.United States | Q-Switched | Class 2 | 2021-04-27 |
| K203491 | PicoLO Nd: YAG Picosecond Laser SystemPigment treatment | Laseroptek Co., Ltd.Korea, Republic of | Picosecond | Class 2 | 2021-04-07 |
| 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 |
| K201801 | Rapid Acoustic Pulse DevicePigment treatment | Soliton, Inc.United States | Nd:YAG | Class 2 | 2021-01-29 |
| K193266 | MIINPigment treatment | Medico USA, Inc.United States | Nd:YAG | Class 2 | 2021-01-22 |
| K201594 | Primelase ExcellenceHair removal | High Technology Products S.L.USpain | Diode | Class 2 | 2020-12-17 |
| K202172 | StarWalkerPigment treatment | Fotona D.O.O.Slovenia | Nd:YAG | Class 2 | 2020-11-19 |
| K202503 | ChromeVascular treatment | Quanta System SpaItaly | Nd:YAG | Class 2 | 2020-11-18 |
| K202758 | Nd: YAG Laser Therapy Systems HM-YL900Pigment treatment | Shangdong Huamei Technology Co., Ltd.China | Nd:YAG | Class 2 | 2020-11-16 |
| K201406 | PicowonPigment treatment | Wontech Co., Ltd.Korea, Republic of | Picosecond | Class 2 | 2020-07-22 |
| K193477 | Nd: YAG Laser Therapy SystemsSurgical cutting | Beijing Kes Biology Technology Co., Ltd.China | Nd:YAG | Class 2 | 2020-06-24 |
| K200116 | PicoSecond Nd: YAG Laser SystemPigment treatment | Shanghai Apolo Medical Technology Co., Ltd.China | Picosecond | Class 2 | 2020-05-28 |
| 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 |
| K192856 | MT OneHair removal | M&T S.R.L.Italy | Diode | Class 2 | 2020-04-24 |
| K200118 | Diode Laser Therapy DeviceHair removal | Shanghai Apolo Medical Technology Co., Ltd.China | Diode | Class 2 | 2020-04-17 |
| K193464 | ND:YAG LaserPigment treatment | Beijing Superlaser Technology Co., Ltd.China | Nd:YAG | Class 2 | 2020-04-13 |
| K192951 | Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunHair removal | Ellipse A/SDenmark | Er:YAG | Class 2 | 2020-03-26 |
| K193609 | Q Switched Nd: YAG Laser machinePigment treatment | Beijing Lead Beauty S & T Co., Ltd.China | Nd:YAG | Class 2 | 2020-03-20 |
| K192483 | MeDioStarHair removal | Asclepion Laser Technologies GmbHUnited States | Diode | Class 2 | 2020-03-13 |
| K200331 | Rapid Acoustic Pulse DevicePigment treatment | Soliton, Inc.United States | Q-Switched | Class 2 | 2020-03-10 |
| K193426 | Elite iQHair removal | Cynosure, LLCUnited States | Alexandrite | Class 2 | 2020-03-09 |
| 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 |
| K192539 | Deka LuxeaHair removal | El.En Electronic Engineering SpaItaly | Diode | Class 2 | 2019-12-16 |
| 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 |
| 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 |
| 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 |
| K183122 | 810nm Diode Laser SystemHair removal | Shanghai Wonderful Opto-Electrics Tech.Co.,LtdChina | Diode | Class 2 | 2019-08-25 |
| 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 |
| K190542 | Soliton Acoustic Wave DevicePigment treatment | Soliton, Inc.United States | Nd:YAG | Class 2 | 2019-05-24 |
| 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 |
| K183392 | PicoLO Nd:YAG Picosecond Laser SystemPigment treatment | Laseroptek Co., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2019-01-04 |
| K182997 | enlighten III Laser SystemPigment treatment | Cutera, Inc.United States | Nd:YAG | Class 2 | 2018-12-12 |
| K181272 | Picocare FamilyPigment treatment | Wontech Co., Ltd.Korea, Republic of | Picosecond | Class 2 | 2018-07-31 |
| K173700 | PICOPLUS Laser SystemPigment treatment | Lutronic CorporationKorea, Republic of | Picosecond | Class 2 | 2018-06-19 |
| K180593 | Vbeam Prima Laser SystemVascular treatment | Syneron-CandelaUnited States | Other | Class 2 | 2018-06-05 |
| K180508 | JOULE SYSTEMSkin resurfacing | Sciton, IncUnited States | CO2 | Class 2 | 2018-05-18 |
| K180224 | ELEMENT-TLVascular treatment | Elemenic Co., Ltd.Korea, Republic of | Other | Class 2 | 2018-03-15 |
| K173199 | PicoSure WorkstationPigment treatment | Cynosure, LLCUnited States | Picosecond | Class 2 | 2018-02-07 |
| K173285 | JOULE SYSTEMSkin resurfacing | Sciton, IncUnited States | Er:YAG | Class 2 | 2018-01-29 |
| K172908 | Q-Switched Nd:YAG Laser SystemSkin resurfacing | Ami, Inc.Korea, Republic of | Q-Switched | Class 2 | 2017-12-07 |