510(k) submissions
Filtered by Skin resurfacing · showing 51–100 of 151
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K233143 | PiXel8-RevealSkin resurfacing | Rohrer AestheticsUnited States | Er:YAG | Class 2 | 2024-02-02 |
| K232769 | BeaMed Laser Surgery FibersSurgical cutting | Bt Beamedical Tachnoogies Ltd. (Beamed)Israel | Laser fiber / delivery | Class 2 | 2023-12-06 |
| K233301 | ULTRApulse Alpha CO2 Laser System, Delivery Devices and AccessoriesSurgical cutting | Lumenis Be, Ltd.Israel | CO2 | Class 2 | 2023-12-01 |
| K231894 | LED Spectrum therapy instrumentAcne treatment | Shenzhenshi Sincoheren S&T Development Co., Ltd.China | LED | Class 2 | 2023-09-20 |
| K223727 | LavieenPigment treatment | Wontech Co., Ltd.Korea, Republic of | CO2 | Class 2 | 2023-08-25 |
| K230268 | ZenPro 40Surgical cutting | BLUECORE COMPANY Co., Ltd.Korea, Republic of | CO2 | Class 2 | 2023-08-10 |
| K230077 | LaserMESkin resurfacing | Neauvia North AmericaUnited States | CO2 | Class 2 | 2023-07-17 |
| K231309 | SCAR 3Skin resurfacing | El.En Electroinc Engineering SpaItaly | CO2 | Class 2 | 2023-06-02 |
| K230990 | Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)Vascular treatment | Candela CorporationUnited States | Other | Class 2 | 2023-06-01 |
| K221623 | FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmSkin resurfacing | Gme German Medical Engineering GmbHUnited States | Laser fiber / delivery | Class 2 | 2023-03-10 |
| K230308 | Alma HarmonyHair removal | Alma Lasers, Inc.United States | IPL | Class 2 | 2023-03-01 |
| K222751 | LED Light Therapy Device, KN-7000LAcne treatment | Xuzhou Kernel Medical Equipment Co., Ltd.China | LED | Class 2 | 2023-02-01 |
| K222221 | DEKA HELIXSurgical cutting | El.En Electronic Engineering SpaItaly | CO2 | Class 2 | 2023-01-04 |
| K223647 | CLEAR+BRILLIANT TOUCH® Laser SystemSkin resurfacing | Solta MedicalUnited States | Er:YAG | Class 2 | 2022-12-29 |
| K222673 | Alexandrite and Nd:YAG Laser models CANLASE and TORLASEHair removal | Canadian Pioneer Medical Technology Corporation (Cpmt Laser)Canada | Alexandrite | Class 2 | 2022-11-17 |
| K221597 | CO2 Laser SystemSurgical cutting | Smedtrum Medical Technology Co., Ltd.Taiwan | CO2 | Class 2 | 2022-09-15 |
| K213267 | Dynamis Pro FamilySurgical cutting | Fotona D.O.O.Slovenia | Er:YAG | Class 2 | 2022-09-08 |
| K213761 | Joule diVa SystemVascular treatment | Sciton, IncUnited States | Diode | Class 2 | 2022-07-19 |
| K213726 | PL-1 Skin Treatment SystemPigment treatment | AVAVA, Inc.United States | Nd:YAG | Class 2 | 2022-06-28 |
| K213250 | Secret DuoSkin resurfacing | Ilooda Co,., Ltd.Korea, Republic of | Other | Class 2 | 2022-06-24 |
| K211979 | Lumenis Y&R Laser SystemSkin resurfacing | Lumenis, Inc.United States | Other | Class 2 | 2022-06-21 |
| K220467 | The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and AccessoriesSurgical cutting | Lumenis Be, Ltd.Israel | CO2 | Class 2 | 2022-05-18 |
| K210183 | Waterlase iPLusSkin resurfacing | Biolase, Inc.United States | Other | Class 2 | 2022-04-21 |
| K210634 | MCL 31 Dermablate SystemSkin resurfacing | Asclepion Laser Technologies GmbHUnited States | CO2 | Class 2 | 2022-04-13 |
| K212611 | CO2 Laser EquipmentSurgical cutting | Beijing Globalipl Development Co., Ltd.China | CO2 | Class 2 | 2022-02-01 |
| 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 |
| K202288 | FinebeamPigment treatment | SNJ Co., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2021-11-19 |
| K211735 | CO2 Laser Machine, Model: BW-203BSurgical cutting | Zhengzhou Bestview ST Co., Ltd.China | CO2 | Class 2 | 2021-10-22 |
| K211362 | SCAR 3Surgical cutting | El.En Electronic Engineering SpaItaly | CO2 | Class 2 | 2021-08-25 |
| K203441 | The Alma Hybrid Laser SystemSurgical cutting | Alma Lasers, Inc.Israel | CO2 | Class 2 | 2021-07-02 |
| K202258 | ERISE Laser handpieceSkin resurfacing | El.En Electronic Engineering SpaItaly | Er:YAG | Class 2 | 2021-04-26 |
| K201171 | LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableSurgical cutting | Leoni Fiber Optics, Inc.United States | Laser fiber / delivery | Class 2 | 2021-04-02 |
| 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 |
| K203241 | OmniGuide BeamPath OTO-U FiberSurgical cutting | Omniguide, Inc.United States | CO2 | Class 2 | 2021-01-14 |
| K203544 | UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and AccessoriesSurgical cutting | Lumenis, Inc.Israel | CO2 | Class 2 | 2020-12-24 |
| K201687 | Avenda Health Treatment SystemSurgical cutting | Avenda Health, Inc.United States | Diode | Class 2 | 2020-11-30 |
| K202250 | Dermatological Carbon Dioxide Laser SystemsSurgical cutting | Zhuolu Jontelaser Manufacturing Technology Co., Ltd.China | CO2 | Class 2 | 2020-11-25 |
| K202172 | StarWalkerPigment treatment | Fotona D.O.O.Slovenia | Nd:YAG | Class 2 | 2020-11-19 |
| K202428 | AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesSkin resurfacing | Lumenis, Inc.Israel | CO2 | Class 2 | 2020-10-22 |
| K201663 | AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesSurgical cutting | Lumenis, Inc.Israel | CO2 | Class 2 | 2020-07-16 |
| K201109 | CO2 Laser Therapy SystemSurgical cutting | Shanghai Apolo Medical Technology Co., Ltd.China | CO2 | Class 2 | 2020-07-15 |
| K200042 | CO2 Laser SystemSurgical cutting | Beijing Superlaser Technology Co., Ltd.China | CO2 | Class 2 | 2020-06-09 |
| K200104 | OxylightAcne treatment | Raja Trading Company, Inc.United States | LED | Class 2 | 2020-06-04 |
| 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 |
| 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 |