510(k) submissions
All indexed GEX clearances · showing 351–400 of 667
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K210142 | Fiber DustSurgical cutting | Quanta System SpaItaly | Laser fiber / delivery | Class 2 | 2021-03-11 |
| K203054 | FlexSysAcne treatment | Gme German Medical Engineering GmbHUnited States | Laser fiber / delivery | Class 2 | 2021-03-05 |
| K210033 | Laser Treatment System, Model: NYX and GraceHair removal | Canadian Pioneer Medical Technology CorporationCanada | Diode | Class 2 | 2021-02-26 |
| K202702 | FLARE Single-Use Surgical Laser FiberSurgical cutting | Realton (Suzhou) Medical Technology Co., Ltd.China | Laser fiber / delivery | Class 2 | 2021-02-26 |
| K203804 | Global Med Systems Milesman Compact LaserHair removal | Global Med Systems SLSpain | Diode | Class 2 | 2021-02-23 |
| 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 |
| 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 |
| K201594 | Primelase ExcellenceHair removal | High Technology Products S.L.USpain | Diode | Class 2 | 2020-12-17 |
| K202601 | Single-use Sterile medical laser fiberSurgical cutting | Realton (Suzhou) Medical Technology Co., Ltd.China | Laser fiber / delivery | Class 2 | 2020-12-15 |
| 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 |
| K202980 | Laser Therapy DeviceHair removal | Shenzhen Leaflife Technology Co., Ltd.China | Diode | Class 2 | 2020-11-19 |
| K202172 | StarWalkerPigment treatment | Fotona D.O.O.Slovenia | Nd:YAG | Class 2 | 2020-11-19 |
| K200693 | K2 MOBILESurgical cutting | Hulaser, Inc.Korea, Republic of | Diode | 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 |
| K202428 | AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesSkin resurfacing | Lumenis, Inc.Israel | CO2 | Class 2 | 2020-10-22 |
| K202041 | Opera EvoSurgical cutting | Quanta System SpaItaly | Diode | Class 2 | 2020-10-15 |
| K201056 | NeuroBlate SystemSurgical cutting | Monteris Medical,United States | Nd:YAG | Class 2 | 2020-08-21 |
| K201406 | PicowonPigment treatment | Wontech Co., Ltd.Korea, Republic of | Picosecond | Class 2 | 2020-07-22 |
| 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 |
| K201455 | Litho 150, Cyber Ho 150Surgical cutting | Quanta System SpaItaly | Holmium (Ho:YAG) | Class 2 | 2020-06-30 |
| K200736 | Stardust MedHair removal | I.T.S. Group S.R.L.Italy | Diode | Class 2 | 2020-06-26 |
| K193477 | Nd: YAG Laser Therapy SystemsSurgical cutting | Beijing Kes Biology Technology Co., Ltd.China | Nd:YAG | Class 2 | 2020-06-24 |
| K200786 | Venus EpileveHair removal | Venus Concept USA, Inc.United States | Diode | Class 2 | 2020-06-09 |
| 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 |
| K200116 | PicoSecond Nd: YAG Laser SystemPigment treatment | Shanghai Apolo Medical Technology Co., Ltd.China | Picosecond | Class 2 | 2020-05-28 |
| K200525 | Medical Diode Laser Hair Removal SystemHair removal | Weifang Mingliang Electronics Co., Ltd.China | Diode | Class 2 | 2020-05-27 |
| K201111 | GentleMax Pro PlusHair removal | Candela CorporationUnited States | Alexandrite | Class 2 | 2020-05-26 |
| 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 |
| K191970 | Diode Laser Hair Removal SystemHair removal | Beijing Sano Laser S&T Development Co.,LtdChina | Diode | Class 2 | 2020-04-06 |
| K192735 | Diode Laser Hair Removal MachineHair removal | Beijing Lead Beauty S & T Co., Ltd.China | Diode | Class 2 | 2020-04-03 |
| K193656 | SkyPulseSurgical cutting | Fotona D.O.O.Slovenia | Er:YAG | Class 2 | 2020-03-27 |
| K192951 | Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunHair removal | Ellipse A/SDenmark | Er:YAG | Class 2 | 2020-03-26 |
| K193661 | LightWalker Laser System FamilySurgical cutting | Fotona D.O.O.Slovenia | Er:YAG | Class 2 | 2020-03-25 |
| K193609 | Q Switched Nd: YAG Laser machinePigment treatment | Beijing Lead Beauty S & T Co., Ltd.China | Nd:YAG | Class 2 | 2020-03-20 |
| K192272 | Wolf445nmSurgical cutting | A.R.C Laser GmbHUnited States | Diode | Class 2 | 2020-03-17 |
| K200110 | SANDRO DualHair removal | Wontech Co., Ltd.Korea, Republic of | Alexandrite | Class 2 | 2020-03-16 |
| K193486 | Epic 980Surgical cutting | Biolase, Inc.United States | Diode | Class 2 | 2020-03-16 |
| K192483 | MeDioStarHair removal | Asclepion Laser Technologies GmbHUnited States | Diode | Class 2 | 2020-03-13 |
| K193367 | elysion-proHair removal | High Technology Products S.L.USpain | Diode | Class 2 | 2020-03-12 |
| K200331 | Rapid Acoustic Pulse DevicePigment treatment | Soliton, Inc.United States | Q-Switched | Class 2 | 2020-03-10 |
