510(k) submissions
All indexed GEX clearances · showing 501–550 of 667
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K173285 | JOULE SYSTEMSkin resurfacing | Sciton, IncUnited States | Er:YAG | Class 2 | 2018-01-29 |
| K172193 | Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser ModulesHair removal | Alma Lasers, Inc.United States | Diode | Class 2 | 2018-01-09 |
| K173002 | 2940 nm Er:Yag Laser HandpieceSkin resurfacing | Quanta System SpaItaly | Er:YAG | Class 2 | 2017-12-13 |
| K172908 | Q-Switched Nd:YAG Laser SystemSkin resurfacing | Ami, Inc.Korea, Republic of | Q-Switched | Class 2 | 2017-12-07 |
| K173038 | CuRAS Nd:YAG LaserSurgical cutting | Ilooda Co,., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2017-12-01 |
| K172819 | LightWalker Laser System FamilySurgical cutting | Fotona D.O.O.Slovenia | Nd:YAG | Class 2 | 2017-12-01 |
| K172771 | Epic Pro 940Surgical cutting | Biolase, Inc.United States | Diode | Class 2 | 2017-11-29 |
| K173169 | Rapid FamilyHair removal | Sharplight Technologies, Ltd.Israel | Other | Class 2 | 2017-11-20 |
| K173305 | NeuroBlate SystemSurgical cutting | Monteris Medical,United States | Nd:YAG | Class 2 | 2017-11-17 |
| K172363 | DEKA SMARTXIDE ULTRASPEEDSurgical cutting | El.En Electronic Engineering SpaItaly | CO2 | Class 2 | 2017-11-17 |
| K172362 | DEKA SMARTXIDE TOUCHSkin resurfacing | El.En Electronic Engineering SpaItaly | CO2 | Class 2 | 2017-11-17 |
| K172639 | PALLAS 308/311 Solid-State UV Laser SystemPigment treatment | Laseroptek Co., Ltd.Korea, Republic of | Other | Class 2 | 2017-11-03 |
| K172077 | Cutera enlighten III Laser SystemPigment treatment | Cutera, Inc.United States | Nd:YAG | Class 2 | 2017-10-27 |
| K172325 | Rhapsody H-30 Holmium Laser SystemSurgical cutting | Cook IncorporatedUnited States | Other | Class 2 | 2017-10-26 |
| K172881 | NeuroBlate SystemSurgical cutting | Monteris Medical,United States | Nd:YAG | Class 2 | 2017-10-20 |
| K172376 | Discovery Pico, Discovery Pico PlusSurgical cutting | Quanta System SpaItaly | Q-Switched | Class 2 | 2017-10-19 |
| K172198 | 585Vascular treatment | Quanta System SpaItaly | Other | Class 2 | 2017-10-17 |
| K172413 | MT ONEHair removal | M&T S.R.L.Italy | Diode | Class 2 | 2017-10-06 |
| K171986 | Sterling Supreme Diode LaserSurgical cutting | CAO Group, Inc.United States | Diode | Class 2 | 2017-09-22 |
| K170179 | LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityHair removal | Lumenis, Inc.Israel | Diode | Class 2 | 2017-09-18 |
| K170409 | PASCAL Synthesis Twinstar Ophthalmic Scanning Laser SystemVascular treatment | Topcon Medical Laser Systems, Inc. (Tmls)United States | Other | Class 2 | 2017-09-12 |
| K171648 | BM.IRISSurgical cutting | BLUECORE COMPANY Co., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2017-09-08 |
| K170970 | EpilaserHair removal | Epilady 2000, LLCIsrael | Diode | Class 2 | 2017-09-01 |
| K171921 | VenaCure EVLT NeverTouch Procedure KitVascular treatment | AngioDynamics, Inc.United States | Other | Class 2 | 2017-08-24 |
| K171227 | StarWalkerHair removal | Fotona D.O.O.Slovenia | Nd:YAG | Class 2 | 2017-08-18 |
| K172096 | FraxisSkin resurfacing | Ilooda Co,., Ltd.Korea, Republic of | CO2 | Class 2 | 2017-08-09 |
| K170060 | M22 and ResurFx SystemsSkin resurfacing | Lumenis, Inc.Israel | Other | Class 2 | 2017-08-09 |
| K170738 | InMode Diolaze XLHair removal | Inmode MD , Ltd.Israel | Diode | Class 2 | 2017-08-07 |
| K171079 | Q-Switched Nd:YAG Laser SystemPigment treatment | Ids, LimitedKorea, Republic of | Q-Switched | Class 2 | 2017-08-01 |
| K172025 | Litho 60Surgical cutting | Quanta System SpaItaly | Other | Class 2 | 2017-07-31 |
| K171945 | Discovery Pico, Discovery Pico PlusSurgical cutting | Quanta System SpaItaly | Q-Switched | Class 2 | 2017-07-28 |
| K170187 | Photodynamic Therapy DeviceAcne treatment | Uvbiotek, LLCUnited States | Other | Class 2 | 2017-07-28 |
| K171255 | Monteris Medical NeuroBlate SystemSurgical cutting | Monteris Medical,United States | Other | Class 2 | 2017-07-25 |
| K170073 | LightMed Dental Laser SystemSurgical cutting | Lightmed Dentaltechnology Corp.Taiwan | Er:YAG | Class 2 | 2017-07-25 |
| K171711 | Thunder, Thunder VT, Thunder HRVascular treatment | Quanta System SpaItaly | Nd:YAG | Class 2 | 2017-07-07 |
| K171009 | LASEMD Laser SystemPigment treatment | Lutronic CorporationKorea, Republic of | Other | Class 2 | 2017-06-23 |
| K163449 | HyPHo Laser SystemSurgical cutting | Hyper Photonics SrlItaly | Other | Class 2 | 2017-06-23 |
| K162886 | DEKA MOTUS AXHair removal | El.En Electronic Engineering SpaItaly | Diode | Class 2 | 2017-06-19 |
| K162659 | Diode Laser Hair Removal SystemHair removal | Shandong Huamei Technology Co., Ltd.China | Diode | Class 2 | 2017-06-16 |
| K170850 | Alma QVascular treatment | Alma Lasers, Inc.Israel | Q-Switched | Class 2 | 2017-06-15 |
| K162755 | PicocarePigment treatment | Wontech Co., Ltd.Korea, Republic of | Q-Switched | Class 2 | 2017-06-12 |
| K170366 | Laser Peripherals, LLC Family of Bare Laser FibersSurgical cutting | Laser Peripherals, LLCUnited States | Other | Class 2 | 2017-06-08 |
| K170626 | Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand pieceHair removal | Alma Lasers, Inc.United States | Diode | Class 2 | 2017-05-31 |
| K170597 | PicoWay Laser SystemPigment treatment | Syneron-CandelaUnited States | Picosecond | Class 2 | 2017-05-25 |
| K163197 | Cook Holmium Laser FiberSurgical cutting | Cook IncorporatedUnited States | Other | Class 2 | 2017-05-24 |
| K163196 | ACTION II Laser SystemSurgical cutting | Lutronic CorporationKorea, Republic of | Er:YAG | Class 2 | 2017-05-24 |
| K170121 | Lumenis Family of Holmium Surgical Lasers and Delivery Devices and AccessoriesSurgical cutting | Lumenis, Inc.Israel | Other | Class 2 | 2017-05-22 |
| K160677 | MICRORUPTOR 6Surgical cutting | Meridian AGSwitzerland | Nd:YAG | Class 2 | 2017-05-19 |
| K170500 | SIROLaser Advance+Surgical cutting | Dentsply SironaUnited States | Diode | Class 2 | 2017-05-16 |
| K163638 | Dental 5 Multi Diode laserSurgical cutting | Bio-Med USA, Inc.United States | Diode | Class 2 | 2017-05-15 |