510(k) submissions
All indexed GEX clearances · showing 301–350 of 667
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K211228 | RossoPigment treatment | Quanta System SpaItaly | Ruby | Class 2 | 2022-02-02 |
| K212611 | CO2 Laser EquipmentSurgical cutting | Beijing Globalipl Development Co., Ltd.China | CO2 | Class 2 | 2022-02-01 |
| K203395 | Platform treatment systemHair removal | Shanghai Apolo Medical Technology Co., Ltd.China | Other | Class 2 | 2022-01-28 |
| K212478 | Dermatological diode laser systemHair removal | Beijing Stelle Laser Technology Co., Ltd.China | Diode | Class 2 | 2022-01-14 |
| K212127 | PicocaremajestyPigment treatment | Wontech Co., Ltd.Korea, Republic of | Picosecond | Class 2 | 2022-01-07 |
| K213225 | Diode Laser System GP900A8, Diode Laser System GP900Q8Hair removal | Shenzhen Gsd Tech Co., Ltd.China | Diode | Class 2 | 2021-12-22 |
| K212492 | Frax 1940 for Nordlys and Frax ProSkin resurfacing | Candela CorporationUnited States | Er:YAG | Class 2 | 2021-12-20 |
| K202848 | S2 Pigment Removal SystemPigment treatment | Lightsense Technologies, Ltd.United Kingdom | Nd:YAG | Class 2 | 2021-12-14 |
| K210847 | UltraClear Fractional Laser SystemSkin resurfacing | Fa International, LPUnited States | CO2 | Class 2 | 2021-12-10 |
| K212573 | PicoLO PremiumPigment treatment | Laseroptek Co., Ltd.Korea, Republic of | Picosecond | Class 2 | 2021-12-08 |
| 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 |
| K212607 | DarwinHair removal | Luvo Medical Technologies, Inc.Canada | Diode | Class 2 | 2021-11-15 |
| K212978 | Diode laser therapy systemHair removal | Beijing Unt Technology Co., Ltd.China | Diode | Class 2 | 2021-11-10 |
| 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 |
| K212502 | Resonic Rapid Acoustic Pulse DevicePigment treatment | Soliton, Inc.United States | Nd:YAG | Class 2 | 2021-11-05 |
| 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 |
| K212793 | Laser Treatment System, Model: Hera, ArmoHair removal | Canadian Pioneer Medical Technology CorporationCanada | Diode | Class 2 | 2021-10-25 |
| K211735 | CO2 Laser Machine, Model: BW-203BSurgical cutting | Zhengzhou Bestview ST Co., Ltd.China | CO2 | Class 2 | 2021-10-22 |
| K212270 | DEKA LipoAISurgical cutting | El.En Electronic Engineering SpaItaly | Nd:YAG | Class 2 | 2021-10-21 |
| K212703 | AcuPulse CO2 Laser System, Delivery Devices and AccessoriesSurgical cutting | Lumenis, Inc.Israel | CO2 | Class 2 | 2021-10-19 |
| K201773 | PICOHIPigment treatment | Hironic Co., Ltd.Korea, Republic of | Picosecond | 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 |
| K211637 | AROMA GRANDHair removal | Daeju Meditech Engineering Co., Ltd.Korea, Republic of | Diode | Class 2 | 2021-09-03 |
| 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 |
| K211335 | Diode Laser Machine, Model Number: BM-100Hair removal | Zhengzhou Bestview ST Co., Ltd.China | Diode | Class 2 | 2021-07-28 |
| K203728 | DarwinHair removal | Luvo Medical Technologies, Inc.Canada | Diode | Class 2 | 2021-07-14 |
| K211821 | DEKA Motus AZHair removal | El.En Electronic Engineering SpaItaly | Alexandrite | Class 2 | 2021-07-06 |
| 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 |
| K210535 | UltraLight LED SystemBody contouring | Rohrer AestheticsUnited States | LED | Class 2 | 2021-05-24 |
| K210168 | Diode Laser Therapy SystemsHair removal | Beijing Kes Biology Technology Co., Ltd.China | Diode | Class 2 | 2021-05-10 |
| 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 |
| K210964 | Resonic Rapid Acoustic Pulse DevicePigment treatment | Soliton, Inc.United States | Q-Switched | Class 2 | 2021-04-27 |
| K210663 | Dermatological Diode Laser SystemsHair removal | Beijing HuaCheng Taike Technology Co., Ltd.China | Diode | Class 2 | 2021-04-26 |
| K202258 | ERISE Laser handpieceSkin resurfacing | El.En Electronic Engineering SpaItaly | Er:YAG | Class 2 | 2021-04-26 |
| K202257 | Dermatological Diode Laser SystemsHair removal | Zhuolu Jontelaser Manufacturing Technology Co., Ltd.China | Diode | Class 2 | 2021-04-23 |
| 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 |
| K210226 | PicoSure WorkstationPigment treatment | Cynosure, LLCUnited States | Picosecond | Class 2 | 2021-03-30 |
| K203788 | DermaV Laser SystemHair removal | Lutronic CorporationKorea, Republic of | Nd:YAG | Class 2 | 2021-03-26 |
| 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 |