510(k) submissions
Filtered by Vascular treatment · showing 101–150 of 220
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| 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 |
| K212073 | Alma Diode Tabletop LaserSurgical cutting | Alma Lasers, Inc.Israel | Diode | Class 2 | 2022-07-14 |
| K221571 | InMode Multi-systemHair removal | InMode , Ltd.Israel | Diode | Class 2 | 2022-06-30 |
| K213726 | PL-1 Skin Treatment SystemPigment treatment | AVAVA, Inc.United States | Nd:YAG | Class 2 | 2022-06-28 |
| K212663 | HELIOS IV 785Surgical cutting | Laseroptek Co., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2022-06-09 |
| K213261 | EpilMEVascular treatment | Neauvia North AmericaUnited States | Diode | Class 2 | 2022-06-02 |
| K220041 | HandPICOAcne treatment | Vydence Medical Industria E Comercio LtdaBrazil | Other | Class 2 | 2022-05-05 |
| K213350 | mJOULE System and AccessoriesVascular treatment | Sciton, IncUnited States | Nd:YAG | Class 2 | 2022-04-15 |
| K211722 | Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresVascular treatment | Canadian Pioneer Medical Technology CorporationCanada | Nd:YAG | Class 2 | 2022-02-25 |
| 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 |
| K212607 | DarwinHair removal | Luvo Medical Technologies, Inc.Canada | Diode | Class 2 | 2021-11-15 |
| K211977 | Medical Diode Laser SystemsVascular treatment | Wuhan Dimed Laser Technology Co., Ltd.China | Diode | Class 2 | 2021-10-26 |
| K202998 | Vydence Zye and Vydence OneAcne treatment | Vydence Medical Industria E Comercio LtdaBrazil | Other | Class 2 | 2021-10-26 |
| K212082 | PicorePigment treatment | Bio-Med USA, Inc.United States | Q-Switched | Class 2 | 2021-10-06 |
| K211637 | AROMA GRANDHair removal | Daeju Meditech Engineering Co., Ltd.Korea, Republic of | Diode | Class 2 | 2021-09-03 |
| 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 |
| K210535 | UltraLight LED SystemBody contouring | Rohrer AestheticsUnited States | LED | Class 2 | 2021-05-24 |
| 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 |
| 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 |
| K201466 | Tranberg CLS Laser ApplicatorSurgical cutting | Clinical Laserthermia Systems, ABSweden | Diode | Class 2 | 2021-03-26 |
| K203054 | FlexSysAcne treatment | Gme German Medical Engineering GmbHUnited States | Laser fiber / delivery | Class 2 | 2021-03-05 |
| K193266 | MIINPigment treatment | Medico USA, Inc.United States | Nd:YAG | Class 2 | 2021-01-22 |
| K201687 | Avenda Health Treatment SystemSurgical cutting | Avenda Health, Inc.United States | Diode | Class 2 | 2020-11-30 |
| 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 |
| K202041 | Opera EvoSurgical cutting | Quanta System SpaItaly | Diode | Class 2 | 2020-10-15 |
| 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 |
| K200104 | OxylightAcne treatment | Raja Trading Company, Inc.United States | LED | Class 2 | 2020-06-04 |
| 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 |
| K193426 | Elite iQHair removal | Cynosure, LLCUnited States | Alexandrite | Class 2 | 2020-03-09 |
| K192600 | Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60Surgical cutting | Quanta System SpaItaly | Holmium (Ho:YAG) | Class 2 | 2020-02-21 |
| K193500 | Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemHair removal | Lumenis, Inc.Israel | IPL | Class 2 | 2020-01-16 |
| K192990 | Litho EvoSurgical cutting | Quanta System SpaItaly | Holmium (Ho:YAG) | Class 2 | 2019-12-20 |
| K192539 | Deka LuxeaHair removal | El.En Electronic Engineering SpaItaly | Diode | Class 2 | 2019-12-16 |
| 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 |
| K191693 | BC-5Vascular treatment | Reveallux, CorpUnited States | Other | Class 2 | 2019-11-01 |
| K192160 | EVO PlatformVascular treatment | Quanta System SpaItaly | Q-Switched | Class 2 | 2019-09-06 |
