510(k) submissions
All indexed GEX clearances · showing 201–250 of 667
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K232709 | Diode laser therapy deviceHair removal | Hebei Zhemai Technology Co., Ltd.China | Diode | Class 2 | 2023-11-30 |
| K232117 | Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)Hair removal | Wuhan Lotuxs Technology Co., Ltd.China | Diode | Class 2 | 2023-11-28 |
| K232532 | Nd:Yag Laser Therapy SystemsSurgical cutting | Beijing Unt Technology Co., Ltd.China | Nd:YAG | Class 2 | 2023-11-02 |
| K233090 | DEKA AGAIN PRO familyHair removal | El.En S.P.A.Italy | Alexandrite | Class 2 | 2023-10-27 |
| K232236 | EchoHair removal | Quanta System SpaItaly | Diode | Class 2 | 2023-10-20 |
| K231901 | Hakon, Hakon SmartHair removal | Medical San Indústria DE Equipamentos Médicos Ltda.Brazil | Diode | Class 2 | 2023-09-28 |
| K231894 | LED Spectrum therapy instrumentAcne treatment | Shenzhenshi Sincoheren S&T Development Co., Ltd.China | LED | Class 2 | 2023-09-20 |
| K231791 | PENTO Nd:YAG and Alexandrite laser systemHair removal | Ilooda Co,., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2023-09-15 |
| K230535 | KARL STORZ Urological Laser AccessoriesSurgical cutting | Karl Storz SE & CO. KGUnited States | Laser fiber / delivery | Class 2 | 2023-09-08 |
| K223727 | LavieenPigment treatment | Wontech Co., Ltd.Korea, Republic of | CO2 | Class 2 | 2023-08-25 |
| K231718 | Holmium Medical LaserSurgical cutting | Allengers Global Healthcare Private LimitedIndia | Holmium (Ho:YAG) | Class 2 | 2023-08-18 |
| K230342 | Phototherapy System (OL-PDT950)Acne treatment | Shanghai Omni Laser Skinology Co., Ltd.China | LED | Class 2 | 2023-08-16 |
| K231054 | V-LaserVascular treatment | Wontech Co., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2023-08-14 |
| K230268 | ZenPro 40Surgical cutting | BLUECORE COMPANY Co., Ltd.Korea, Republic of | CO2 | Class 2 | 2023-08-10 |
| K231548 | Medical Diode Laser, Model S1ProVascular treatment | Wuhan Pioon Technology Co., Ltd.China | Diode | Class 2 | 2023-08-03 |
| K222862 | SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCHair removal | Lotuxs Medtech (Suzhou) Co., Ltd.China | Diode | Class 2 | 2023-07-30 |
| 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 |
| K230077 | LaserMESkin resurfacing | Neauvia North AmericaUnited States | CO2 | Class 2 | 2023-07-17 |
| K230660 | AviClear Laser SystemAcne treatment | Cutera, Inc.United States | Diode | Class 2 | 2023-06-06 |
| K212734 | Diode laser therapy deviceSurgical cutting | Triangel Rsd LimitedChina | Diode | Class 2 | 2023-06-06 |
| K212733 | Diode laser therapy deviceSurgical cutting | Beijing Star New Tech Co., Ltd.China | Diode | Class 2 | 2023-06-06 |
| K231309 | SCAR 3Skin resurfacing | El.En Electroinc Engineering SpaItaly | CO2 | Class 2 | 2023-06-02 |
| K230990 | Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)Vascular treatment | Candela CorporationUnited States | Other | Class 2 | 2023-06-01 |
| K230580 | Diode Laser SystemHair removal | Smedtrum Medical Technology Co., Ltd.Taiwan | Diode | Class 2 | 2023-05-26 |
| K230460 | Laser Thermal Therapy KitSurgical cutting | Elesta S.P.AItaly | Nd:YAG | Class 2 | 2023-05-22 |
| K230373 | HELIOS 785 PicoSurgical cutting | Laseroptek Co., Ltd.Korea, Republic of | Q-Switched | Class 2 | 2023-05-22 |
| K230340 | Lucas PlusSurgical cutting | Amt Engineering Co., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2023-05-04 |
| K222352 | Epildream HP 4000 MEDHair removal | D.E.A Project S.R.1.Italy | Diode | Class 2 | 2023-04-27 |
| K230819 | OmniGuide RFID Surgical Laser FibersSurgical cutting | Omni-Guide Holdings, Inc.United States | Laser fiber / delivery | Class 2 | 2023-04-21 |
| K230274 | Medical Diode Laser (M2)Surgical cutting | Wuhan Pioon Technology Co., Ltd.China | Diode | Class 2 | 2023-03-31 |
| K223778 | Diode Laser Hair Removal System (RD-SLD600)Hair removal | Shanghai Omni Laser Skinology Co., Ltd.China | Diode | Class 2 | 2023-03-31 |
| K222485 | SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG LaserHair removal | Ids, LimitedKorea, Republic of | Alexandrite | Class 2 | 2023-03-29 |
| 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 |
| K230308 | Alma HarmonyHair removal | Alma Lasers, Inc.United States | IPL | Class 2 | 2023-03-01 |
| K230371 | The Alma Soprano TitaniumHair removal | Alma Lasers, Inc.United States | Diode | Class 2 | 2023-02-22 |
| K213669 | LIGHTSCALPEL LS-4020Surgical cutting | Lightscalpel, Inc.United States | CO2 | Class 2 | 2023-02-15 |
| K223680 | Eneka ProHair removal | TermosaludSpain | Diode | Class 2 | 2023-02-10 |
| K222751 | LED Light Therapy Device, KN-7000LAcne treatment | Xuzhou Kernel Medical Equipment Co., Ltd.China | LED | Class 2 | 2023-02-01 |
| 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 |
| K223588 | PALLAS PremiumPigment treatment | Laseroptek Co., Ltd.Korea, Republic of | Other | Class 2 | 2023-01-26 |
| K223404 | Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VVascular treatment | Quanta System SpaItaly | Nd:YAG | Class 2 | 2023-01-20 |
| K223540 | AvalancheLase FamilyHair removal | Fotona D.O.O.Slovenia | Alexandrite | Class 2 | 2023-01-19 |
| K223685 | SmoothCool HR SystemHair removal | Jeisys Medical IncorporatedKorea, Republic of | Diode | Class 2 | 2023-01-04 |
| K222221 | DEKA HELIXSurgical cutting | El.En Electronic Engineering SpaItaly | CO2 | Class 2 | 2023-01-04 |
| K223647 | CLEAR+BRILLIANT TOUCH® Laser SystemSkin resurfacing | Solta MedicalUnited States | Er:YAG | Class 2 | 2022-12-29 |
| K213105 | Epilaser AbsoluteHair removal | Epilady 2000, LLCIsrael | Diode | Class 2 | 2022-12-13 |
| K222916 | US 450 Diode Laser EquipmentHair removal | Beijing Globalipl Development Co., Ltd.China | Diode | Class 2 | 2022-12-09 |
| K222701 | MANTA LaserSurgical cutting | Squalus Med , Ltd.Israel | Diode | Class 2 | 2022-11-18 |
| K222673 | Alexandrite and Nd:YAG Laser models CANLASE and TORLASEHair removal | Canadian Pioneer Medical Technology Corporation (Cpmt Laser)Canada | Alexandrite | Class 2 | 2022-11-17 |
