510(k) submissions
Filtered by Other · showing 51–89 of 89
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K231945 | VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure KitsVascular treatment | AngioDynamics, Inc.United States | Laser fiber / delivery | Class 2 | 2023-07-20 |
| K230819 | OmniGuide RFID Surgical Laser FibersSurgical cutting | Omni-Guide Holdings, Inc.United States | Laser fiber / delivery | Class 2 | 2023-04-21 |
| K222983 | NeuroBlate Fusion-S Software V3.17Surgical cutting | Monteris Medical,United States | Nd:YAG | Class 2 | 2023-03-15 |
| 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 |
| K221306 | SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and AccessoriesSurgical cutting | Gyrus Acmi, Inc.United States | Thulium fiber | Class 2 | 2023-01-27 |
| K223647 | CLEAR+BRILLIANT TOUCH® Laser SystemSkin resurfacing | Solta MedicalUnited States | Er:YAG | Class 2 | 2022-12-29 |
| K222629 | Resonic Rapid Acoustic Pulse DevicePigment treatment | Zeltiq Aesthetics, Inc.United States | Q-Switched | Class 2 | 2022-09-25 |
| K221427 | V-LaserSurgical cutting | Wontech Co., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2022-08-24 |
| K213252 | Dornier ThulioSurgical cutting | Dornier Medtech America, Inc.United States | Thulium fiber | Class 2 | 2022-07-27 |
| K213761 | Joule diVa SystemVascular treatment | Sciton, IncUnited States | Diode | Class 2 | 2022-07-19 |
| K212492 | Frax 1940 for Nordlys and Frax ProSkin resurfacing | Candela CorporationUnited States | Er:YAG | Class 2 | 2021-12-20 |
| K211517 | Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT Thulium Fiber Laser, Thulium Fiber Laser 1940 nm, Optica XT Thulium Fiber Laser 1940 nm, Optica XT 60 Thulium Fiber Laser 1940 nm, Optica XT Superpulse Thulium Fiber Laser 1940 nm, OptiLITE Laser Fibers and AccessoriesSurgical cutting | Convergent Laser TechnologiesUnited States | Thulium fiber | Class 2 | 2021-11-09 |
| K212270 | DEKA LipoAISurgical cutting | El.En Electronic Engineering SpaItaly | Nd:YAG | Class 2 | 2021-10-21 |
| K210951 | Leonardo Mini BlueSurgical cutting | Ceramoptec GmbHGermany | Diode | Class 2 | 2021-09-01 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| K201455 | Litho 150, Cyber Ho 150Surgical cutting | Quanta System SpaItaly | Holmium (Ho:YAG) | Class 2 | 2020-06-30 |
| 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 |
| K192272 | Wolf445nmSurgical cutting | A.R.C Laser GmbHUnited States | Diode | Class 2 | 2020-03-17 |
| 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 |
| 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 |
| K191962 | Vitra 2Ophthalmic | Quantel MedicalFrance | Nd:YAG | Class 2 | 2019-12-05 |
| K192331 | LaseMD LEO Laser SystemPigment treatment | Lutronic GlobalUnited States | Thulium fiber | Class 2 | 2019-11-12 |
| K190319 | Waterlase Laser System FamilyDental | Biolase, Inc.United States | Er:YAG | Class 2 | 2019-10-10 |
| 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 |
| K183199 | TRIO HandpieceSurgical cutting | Omniguide, Inc.United States | CO2 | Class 2 | 2019-05-02 |
| K182173 | Joule SystemPigment treatment | Sciton, IncUnited States | Thulium fiber | Class 2 | 2019-03-06 |