510(k) submissions
Filtered by Other · showing 1–50 of 124
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K250504 | Leonardo DusterSurgical cutting | Ceramoptec GmbHUnited States | Other | Class 2 | 2025-07-14 |
| K251149 | AviClear Laser SystemAcne treatment | Cutera, Inc.United States | Other | Class 2 | 2025-07-11 |
| K250195 | MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60)Vascular treatment | Matelaser, Inc.United States | Other | Class 2 | 2025-05-30 |
| K242132 | FREDDOSurgical cutting | Fabinject Lndustria E Comercio Lmportacao E Exportacao LtdaBrazil | Other | Class 2 | 2024-10-18 |
| K242035 | Accure Laser SystemAcne treatment | Accure Acne, Inc.United States | Other | Class 2 | 2024-10-11 |
| K242349 | FoLixHair removal | Lumenis Be, Ltd.Israel | Other | Class 2 | 2024-09-09 |
| K242142 | Fraxel® FTX Laser SystemSkin resurfacing | Solta MedicalUnited States | Other | Class 2 | 2024-08-21 |
| K241699 | SUPER VELOCESurgical cutting | Ilooda Co,., Ltd.Korea, Republic of | Other | Class 2 | 2024-08-13 |
| K232858 | ORskin BlueSurgical cutting | Megabay S.A.Argentina | Other | Class 2 | 2024-05-01 |
| K233416 | Cryojet Plus (SHE-ACP001-1)Skin tightening | Beijing Sano Laser S&T Development Co.,LtdChina | Other | Class 2 | 2024-02-06 |
| K230990 | Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)Vascular treatment | Candela CorporationUnited States | Other | Class 2 | 2023-06-01 |
| K223588 | PALLAS PremiumPigment treatment | Laseroptek Co., Ltd.Korea, Republic of | Other | Class 2 | 2023-01-26 |
| K222109 | Accure LaserAcne treatment | Accure Acne, Inc.United States | Other | Class 2 | 2022-11-17 |
| K221083 | Smartlux MiniAcne treatment | Medmix Co., Ltd.Korea, Republic of | Other | Class 2 | 2022-07-12 |
| K213250 | Secret DuoSkin resurfacing | Ilooda Co,., Ltd.Korea, Republic of | Other | Class 2 | 2022-06-24 |
| K211979 | Lumenis Y&R Laser SystemSkin resurfacing | Lumenis, Inc.United States | Other | Class 2 | 2022-06-21 |
| K220793 | InnoVoyce Laser FiberSurgical cutting | InnovoyceUnited States | Other | Class 2 | 2022-05-25 |
| K211534 | RevoLix HTLSurgical cutting | Lisa Laser Products GmbHUnited States | Other | Class 2 | 2022-05-19 |
| K220041 | HandPICOAcne treatment | Vydence Medical Industria E Comercio LtdaBrazil | Other | Class 2 | 2022-05-05 |
| K213594 | ECHOLASER X4Surgical cutting | Elesta S.P.AItaly | Other | Class 2 | 2022-05-03 |
| K220189 | LISA Laser Surgical FibersSurgical cutting | Omni-Guide Holdings, Inc.United States | Other | Class 2 | 2022-04-29 |
| K210183 | Waterlase iPLusSkin resurfacing | Biolase, Inc.United States | Other | Class 2 | 2022-04-21 |
| K213484 | SmoothCool HR SystemHair removal | Jeisys Medical IncorporatedKorea, Republic of | Other | Class 2 | 2022-04-20 |
| K220103 | LED Therapy Device (Planar LED/Planar LED mini)Hair removal | Shenzhen Leaflife Technology Co., Ltd.China | Other | Class 2 | 2022-04-12 |
| K213461 | AviClear Laser SystemAcne treatment | Cutera, Inc.United States | Other | Class 2 | 2022-03-24 |
| K220426 | Fiber Dust PROSurgical cutting | Quanta System SpaItaly | Other | Class 2 | 2022-03-16 |
| K220020 | Cryo 7Skin tightening | Zimmer Medizinsysteme GmbHUnited States | Other | Class 2 | 2022-02-04 |
| K213554 | Sentient Manufacturing Laser FiberSurgical cutting | Sentient Manufacturing , LLCUnited States | Other | Class 2 | 2022-02-02 |
| K203395 | Platform treatment systemHair removal | Shanghai Apolo Medical Technology Co., Ltd.China | Other | Class 2 | 2022-01-28 |
| K202998 | Vydence Zye and Vydence OneAcne treatment | Vydence Medical Industria E Comercio LtdaBrazil | Other | Class 2 | 2021-10-26 |
| K202043 | Secret DuoSurgical cutting | Ilooda Co,., Ltd.Korea, Republic of | Other | Class 2 | 2021-04-23 |
| K193478 | XTRAC Momentum Excimer Laser SystemSkin resurfacing | Strata Skin Sciences, Inc.United States | Other | Class 2 | 2020-01-14 |
| K191501 | PALLAS 308/311 Solid-State UV Laser SystemSkin resurfacing | Laseroptek Co., Ltd.Korea, Republic of | Other | Class 2 | 2020-01-03 |
| K191693 | BC-5Vascular treatment | Reveallux, CorpUnited States | Other | Class 2 | 2019-11-01 |
| K190392 | WaveLight FS200 Patient InterfaceSurgical cutting | Alcon Laboratories, Inc.United States | Other | Class 2 | 2019-03-26 |
| K190007 | Vydence Laser FamilyAcne treatment | Vydence Medical Industria E Comercio LtdaBrazil | Other | Class 2 | 2019-03-01 |
| K182831 | SabreLine and SabreGuard Laser FibersSurgical cutting | Coloplast Corp.United States | Other | Class 2 | 2018-12-10 |
| K173676 | A-FITBody contouring | Hironic Co., Ltd.Korea, Republic of | Other | Class 2 | 2018-09-14 |
| K181662 | Iridex TruFocus LIO PremiereSurgical cutting | Iridex CorporationUnited States | Other | Class 2 | 2018-09-05 |
| K181510 | ECHOLASER X4Surgical cutting | El.En Electronic Engineering SpaItaly | Other | Class 2 | 2018-09-04 |
| K181480 | MMD TipSurgical cutting | Strata Skin Sciences, Inc.United States | Other | Class 2 | 2018-08-01 |
| K181431 | Laser Ureteral CatheterSurgical cutting | Cook IncorporatedUnited States | Other | Class 2 | 2018-07-30 |
| K181044 | 400um Perforator and Accessory Vein Ablation KitVascular treatment | AngioDynamics, Inc.United States | Other | Class 2 | 2018-07-05 |
| K180593 | Vbeam Prima Laser SystemVascular treatment | Syneron-CandelaUnited States | Other | Class 2 | 2018-06-05 |
| K180922 | Empower H100, Cyber Ho 100, Litho 100Surgical cutting | Quanta System SpaItaly | Other | Class 2 | 2018-05-08 |
| K180140 | ProFlex Laser FibersSurgical cutting | Innovaquartz, LLCUnited States | Other | Class 2 | 2018-04-20 |
| K171443 | Etherea MXSurgical cutting | Vydence Medical Industria E Comercio LtdaBrazil | Other | Class 2 | 2018-04-20 |
| K180426 | Empower H35Surgical cutting | Quanta System SpaItaly | Other | Class 2 | 2018-03-16 |
| K180423 | Empower H65Surgical cutting | Quanta System SpaItaly | Other | Class 2 | 2018-03-15 |
| K180406 | Ellipse YdunSurgical cutting | Ellipse A/SDenmark | Other | Class 2 | 2018-03-15 |