510(k) submissions
All indexed GEX clearances · showing 451–500 of 667
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K183392 | PicoLO Nd:YAG Picosecond Laser SystemPigment treatment | Laseroptek Co., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2019-01-04 |
| K182045 | Lotus III Multi-Pulsed Er: Yag Laser SystemSurgical cutting | Laseroptek Co., Ltd.Korea, Republic of | Er:YAG | Class 2 | 2018-12-27 |
| K182997 | enlighten III Laser SystemPigment treatment | Cutera, Inc.United States | Nd:YAG | Class 2 | 2018-12-12 |
| K183307 | Magma Spark Pro (Magma Spark Plus, Alpha)Hair removal | Formatk Systems , Ltd.Israel | Diode | Class 2 | 2018-12-11 |
| K182831 | SabreLine and SabreGuard Laser FibersSurgical cutting | Coloplast Corp.United States | Other | Class 2 | 2018-12-10 |
| K182663 | Nobleen Long Pulsed Alexandrite & Nd: YAG Laser SystemHair removal | Finemec Co., Ltd.Korea, Republic of | Alexandrite | Class 2 | 2018-11-30 |
| K182604 | New EraHair removal | Step UP Skin Laser, LLCUnited States | Diode | Class 2 | 2018-11-14 |
| K182270 | Cellene CO2 Laser SystemSurgical cutting | Bio-Med USA, Inc.United States | CO2 | Class 2 | 2018-11-02 |
| K182088 | XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroSurgical cutting | Fotona D.O.O.Slovenia | Er:YAG | Class 2 | 2018-10-31 |
| K182669 | Youlaser CO2Surgical cutting | Quanta System SpaItaly | CO2 | Class 2 | 2018-10-17 |
| K182036 | NeuroBlate SystemSurgical cutting | Monteris Medical,United States | Nd:YAG | Class 2 | 2018-10-15 |
| K181867 | Deka Smartxide2 TrioSurgical cutting | El.En Electronic Engineering SpaItaly | CO2 | Class 2 | 2018-10-02 |
| K181632 | Venacure 1470 ProVascular treatment | Quanta System SpaItaly | Diode | Class 2 | 2018-09-17 |
| K173827 | LightScalpelSurgical cutting | Lightscalpel, Inc.United States | CO2 | Class 2 | 2018-09-14 |
| 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 |
| K181486 | DEKA Motus AYHair removal | El.En Electronic Engineering SpaItaly | Alexandrite | Class 2 | 2018-08-30 |
| K181480 | MMD TipSurgical cutting | Strata Skin Sciences, Inc.United States | Other | Class 2 | 2018-08-01 |
| K181272 | Picocare FamilyPigment treatment | Wontech Co., Ltd.Korea, Republic of | Picosecond | Class 2 | 2018-07-31 |
| K181431 | Laser Ureteral CatheterSurgical cutting | Cook IncorporatedUnited States | Other | Class 2 | 2018-07-30 |
| K180518 | GME LinScan Lite 808 Laser SystemHair removal | Gme German Medical Engineering GmbHUnited States | Diode | Class 2 | 2018-07-23 |
| K181019 | Diode Laser SystemHair removal | Guangzhou Huafei Tongda Technology Co., Ltd.China | Diode | Class 2 | 2018-07-16 |
| K181523 | Syneron CO2RE SystemSurgical cutting | Syneron-CandelaUnited States | CO2 | Class 2 | 2018-07-11 |
| K180967 | Dental Diode Laser SystemSurgical cutting | Lazon Medical Laser Co., Ltd.China | Diode | Class 2 | 2018-07-11 |
| K181044 | 400um Perforator and Accessory Vein Ablation KitVascular treatment | AngioDynamics, Inc.United States | Other | Class 2 | 2018-07-05 |
| K173359 | Fractional CO2 Surgical Laser SystemSkin resurfacing | Ami, Inc.Korea, Republic of | CO2 | Class 2 | 2018-07-05 |
| K180993 | Beacon Advanced CO2 Laser SystemSurgical cutting | Omniguide, Inc.United States | CO2 | Class 2 | 2018-06-28 |
| K173700 | PICOPLUS Laser SystemPigment treatment | Lutronic CorporationKorea, Republic of | Picosecond | Class 2 | 2018-06-19 |
| K180719 | InMode Diolaze SystemHair removal | Inmode MD , Ltd.United States | Diode | Class 2 | 2018-06-14 |
| K180593 | Vbeam Prima Laser SystemVascular treatment | Syneron-CandelaUnited States | Other | Class 2 | 2018-06-05 |
| K180508 | JOULE SYSTEMSkin resurfacing | Sciton, IncUnited States | CO2 | Class 2 | 2018-05-18 |
| 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 |
| K180353 | Diode laser hair removal deviceHair removal | Zhengzhou PZ Laser Slim Technology Co., Ltd.China | Diode | Class 2 | 2018-04-17 |
| K180597 | AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUOSurgical cutting | Lumenis, Inc.Israel | CO2 | Class 2 | 2018-04-03 |
| 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 |
| K180224 | ELEMENT-TLVascular treatment | Elemenic Co., Ltd.Korea, Republic of | Other | Class 2 | 2018-03-15 |
| K180044 | SIROLaser BlueSurgical cutting | Dentsply SironaUnited States | Other | Class 2 | 2018-03-08 |
| K180350 | Dornier Medilas H Solvo 35 LaserSurgical cutting | Dornier Medtech America, Inc.United States | Other | Class 2 | 2018-03-07 |
| K172818 | LMT-3000Surgical cutting | Lameditech Co. , Ltd.Korea, Republic of | Other | Class 2 | 2018-03-07 |
| K173677 | InMode VLazeVascular treatment | Inmode MD , Ltd.Israel | Other | Class 2 | 2018-02-23 |
| K173067 | LightForce LTS Model 1000, 1500, 2500, and 4000Vascular treatment | Litecure, LLCUnited States | Other | Class 2 | 2018-02-22 |
| K180193 | DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto)Skin resurfacing | El.En Electronic Engineering SpaItaly | CO2 | Class 2 | 2018-02-21 |
| K180158 | Surgical Laser fibersSurgical cutting | Quanta System SpaItaly | Other | Class 2 | 2018-02-14 |
| K172439 | Siberian FitSurgical cutting | VydenceBrazil | Other | Class 2 | 2018-02-14 |
| K173199 | PicoSure WorkstationPigment treatment | Cynosure, LLCUnited States | Picosecond | Class 2 | 2018-02-07 |