510(k) submissions
Filtered by Surgical cutting · showing 151–200 of 340
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K212703 | AcuPulse CO2 Laser System, Delivery Devices and AccessoriesSurgical cutting | Lumenis, Inc.Israel | CO2 | Class 2 | 2021-10-19 |
| K212082 | PicorePigment treatment | Bio-Med USA, Inc.United States | Q-Switched | Class 2 | 2021-10-06 |
| K203799 | ProFlex CO2 Laser FiberSurgical cutting | Innovaquartz, LLCUnited States | CO2 | Class 2 | 2021-09-20 |
| K210951 | Leonardo Mini BlueSurgical cutting | Ceramoptec GmbHGermany | Diode | Class 2 | 2021-09-01 |
| K211362 | SCAR 3Surgical cutting | El.En Electronic Engineering SpaItaly | CO2 | Class 2 | 2021-08-25 |
| K211761 | UltraLase Flexible CO2 Laser WaveguideSurgical cutting | W & R Investments, LLC Dba Laser EngineeringUnited States | CO2 | Class 2 | 2021-07-30 |
| K203441 | The Alma Hybrid Laser SystemSurgical cutting | Alma Lasers, Inc.Israel | CO2 | Class 2 | 2021-07-02 |
| K202991 | Fotona XPulse Pro Laser PlatformSurgical cutting | Fotona D.O.O.Slovenia | Diode | Class 2 | 2021-06-22 |
| K202828 | Surgical Green Laser SystemSurgical cutting | Realton (Suzhou) Medical Technology Co., Ltd.China | Nd:YAG | Class 2 | 2021-06-04 |
| K211401 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)Surgical cutting | Gyrus Acmi, Inc.United States | Laser fiber / delivery | Class 2 | 2021-06-03 |
| 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 |
| K202043 | Secret DuoSurgical cutting | Ilooda Co,., Ltd.Korea, Republic of | Other | Class 2 | 2021-04-23 |
| K203491 | PicoLO Nd: YAG Picosecond Laser SystemPigment treatment | Laseroptek Co., Ltd.Korea, Republic of | Picosecond | Class 2 | 2021-04-07 |
| 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 |
| K201466 | Tranberg CLS Laser ApplicatorSurgical cutting | Clinical Laserthermia Systems, ABSweden | Diode | Class 2 | 2021-03-26 |
| K202985 | LightWalker Laser System FamilySurgical cutting | Fotona D.O.O.Slovenia | Er:YAG | Class 2 | 2021-03-19 |
| K210142 | Fiber DustSurgical cutting | Quanta System SpaItaly | Laser fiber / delivery | Class 2 | 2021-03-11 |
| K202702 | FLARE Single-Use Surgical Laser FiberSurgical cutting | Realton (Suzhou) Medical Technology Co., Ltd.China | Laser fiber / delivery | Class 2 | 2021-02-26 |
| 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 |
| 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 |
| 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 |
| 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 |
| K193477 | Nd: YAG Laser Therapy SystemsSurgical cutting | Beijing Kes Biology Technology Co., Ltd.China | Nd:YAG | Class 2 | 2020-06-24 |
| K200042 | CO2 Laser SystemSurgical cutting | Beijing Superlaser Technology Co., Ltd.China | CO2 | Class 2 | 2020-06-09 |
| K193656 | SkyPulseSurgical cutting | Fotona D.O.O.Slovenia | Er:YAG | Class 2 | 2020-03-27 |
| 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 |
| K193486 | Epic 980Surgical cutting | Biolase, Inc.United States | Diode | Class 2 | 2020-03-16 |
| 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 |
| K193375 | NeuroBlate SystemSurgical cutting | Monteris Medical,United States | Nd:YAG | Class 2 | 2020-01-03 |
| K192990 | Litho EvoSurgical cutting | Quanta System SpaItaly | Holmium (Ho:YAG) | Class 2 | 2019-12-20 |
| 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 |
| K190319 | Waterlase Laser System FamilyDental | Biolase, Inc.United States | Er:YAG | Class 2 | 2019-10-10 |