510(k) submissions
All indexed GEX clearances · showing 551–600 of 667
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K170734 | Venus Silk.expertSurgical cutting | Cyden LimitedUnited Kingdom | Other | Class 2 | 2017-05-08 |
| K170718 | Iridex TruFocus LIO PremiereVascular treatment | Iridex CorporationUnited States | Other | Class 2 | 2017-05-03 |
| K162334 | U.S. Laser Worx Patriot 1 family of lasersSurgical cutting | U.S. Laser WorxUnited States | Other | Class 2 | 2017-04-27 |
| K170936 | Cutera enlighten III Laser SystemPigment treatment | Cutera, Inc.United States | Nd:YAG | Class 2 | 2017-04-25 |
| K170215 | LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDockSkin resurfacing | Patient Pocket, LLCUnited States | CO2 | Class 2 | 2017-04-19 |
| K170724 | NeuroBlate SystemSurgical cutting | Monteris Medical,United States | Nd:YAG | Class 2 | 2017-04-07 |
| K160549 | MEDICAL DIODE LASER SYSTEMSVascular treatment | Wuhan Gigaa Optronics Technology Co., Ltd.China | Diode | Class 2 | 2017-04-07 |
| K161257 | MultiPulse HoPLUSSurgical cutting | Asclepion Laser Technologies GmbHUnited States | Other | Class 2 | 2017-03-31 |
| K162556 | LIGHTFUSION LED SYSTEMSkin tightening | Vitage Led, Ltd.United Kingdom | Other | Class 2 | 2017-03-24 |
| K163103 | Tranberg CLS Diffusor Laser FiberSurgical cutting | Clinical Laserthermia Systems, ABSweden | Other | Class 2 | 2017-03-23 |
| K163655 | SparklingSurgical cutting | Shanghai Wonderful Opto-Electrics Tech.Co.,LtdChina | Other | Class 2 | 2017-03-17 |
| K170331 | Cyber HoSurgical cutting | Quanta System SpaItaly | Other | Class 2 | 2017-03-03 |
| K162837 | Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532™ Laser SystemVascular treatment | Lumenis, Inc.Israel | Other | Class 2 | 2017-02-28 |
| K161926 | ND YAG Q-switch Laser Therapy MachinePigment treatment | Beijing Adss Development Co., Ltd.China | Nd:YAG | Class 2 | 2017-02-22 |
| K163123 | Q-Switched Nd:YAG Laser Therapy SystemsPigment treatment | Beijing Sincoheren Science and Technology Development Co.China | Q-Switched | Class 2 | 2017-02-02 |
| K162454 | PicoWay Laser SystemPigment treatment | Syneron-CandelaUnited States | Picosecond | Class 2 | 2017-02-01 |
| K162851 | eLyx-PROAcne treatment | Intelligent Sensory Concept SASwitzerland | Other | Class 2 | 2017-01-24 |
| K163128 | Epic ProSurgical cutting | Biolase, Inc.United States | Diode | Class 2 | 2017-01-11 |
| K162765 | Venus Velocity Diode Laser SystemHair removal | Venus Concept , Ltd.United States | Diode | Class 2 | 2017-01-11 |
| K162114 | Photon, Photon PlusSurgical cutting | Zolar Technology & Mfg Co., Inc.Canada | Other | Class 2 | 2016-12-12 |
| K161632 | FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Hair removal | Bios S.R.L.Italy | Nd:YAG | Class 2 | 2016-12-08 |
| K163222 | Discovery Pico FamilyPigment treatment | Quanta System SpaItaly | Q-Switched | Class 2 | 2016-12-05 |
| K163009 | LithoSurgical cutting | Quanta System SpaItaly | Other | Class 2 | 2016-12-01 |
| K162191 | NAVILAS Laser SystemVascular treatment | Od-Os GmbHUnited States | Other | Class 2 | 2016-11-22 |
| K162363 | V30 system, V-Form Handpiece BC Medium applicatorAcne treatment | Viora , Ltd.Israel | Other | Class 2 | 2016-11-18 |
| K162914 | VenaCure EVLT NeverTouch Procedure KitVascular treatment | AngioDynamics, Inc.United States | Diode | Class 2 | 2016-11-16 |
| K161692 | Diode Laser Therapy MachineHair removal | Beijing Adss Development Co., Ltd.China | Diode | Class 2 | 2016-11-16 |
| K162781 | Magma SparkHair removal | Formatk Systems , Ltd.Israel | Diode | Class 2 | 2016-11-09 |
| K161670 | Lucid Q-PTP / HWA 55Surgical cutting | Bison Medical Co, Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2016-11-02 |
| K160488 | Cutera enlighten III Laser SystemPigment treatment | Cutera, Inc.United States | Q-Switched | Class 2 | 2016-10-28 |
| K160312 | FRAXIS DUOSkin resurfacing | Ilooda Co,., Ltd.Korea, Republic of | CO2 | Class 2 | 2016-10-28 |
| K162169 | EdgeOne CO2 LaserSurgical cutting | Jeisys Medical IncorporatedKorea, Republic of | CO2 | Class 2 | 2016-10-27 |
| K162762 | NeuroBlate SystemSurgical cutting | Monteris Medical,United States | Nd:YAG | Class 2 | 2016-10-26 |
| K161981 | Olive PlusHair removal | Ama Network, Inc.United States | Diode | Class 2 | 2016-10-14 |
| K161925 | CO2 Laser Therapy MachineSurgical cutting | Beijing Adss Development Co., Ltd.China | CO2 | Class 2 | 2016-10-05 |
| K162416 | IRIDEX Cyclo G6 Laser System, G-Probe IlluminateSurgical cutting | Iridex CorporationUnited States | Other | Class 2 | 2016-09-29 |
| K161185 | LUCERNA Dental LaserSurgical cutting | Viax Dental LabCosta Rica | Diode | Class 2 | 2016-09-26 |
| K160413 | Sterling 5W Diode LaserSurgical cutting | CAO Group, Inc.United States | Diode | Class 2 | 2016-09-21 |
| K161162 | Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys UltraHair removal | Ellipse A/SDenmark | Other | Class 2 | 2016-09-16 |
| K161356 | Matrix LS-40 CO2 Laser SystemSurgical cutting | Shanghai Wonderful Opto-Electrics Tech.Co.,LtdChina | CO2 | Class 2 | 2016-09-09 |
| K161503 | ORIONVascular treatment | Yerim Engineering Co., Ltd.Korea, Republic of | Other | Class 2 | 2016-08-26 |
| K161403 | A.R.C. Laser Surgical Fibers and ProbesSurgical cutting | A.R.C Laser GmbHUnited States | Other | Class 2 | 2016-08-16 |
| K161771 | Medilas H Laser FibersSurgical cutting | Dornier Medtech America, Inc.United States | Other | Class 2 | 2016-07-28 |
| K161669 | Waterlase ExpressSurgical cutting | Biolase, Inc.United States | Other | Class 2 | 2016-07-28 |
| K153124 | DuraLazeTM HoLEP Laser FiberSurgical cutting | Medkey, LLCUnited States | Other | Class 2 | 2016-07-26 |
| K160607 | PicoWay Laser SystemPigment treatment | Syneron-CandelaUnited States | Picosecond | Class 2 | 2016-07-05 |
| K152737 | Lite TouchSurgical cutting | Focus Medical, LLCUnited States | Er:YAG | Class 2 | 2016-06-29 |
| K152667 | ATOVEN-Reusable Laser FiberVascular treatment | Diotech COKorea, Republic of | Diode | Class 2 | 2016-06-09 |
| K160012 | O-pel Laser and families of probe delivery devicesSurgical cutting | Precise Light SurgicalUnited States | Other | Class 2 | 2016-06-02 |
| K152856 | Helios IIISurgical cutting | Laseroptek Co., Ltd.Korea, Republic of | Other | Class 2 | 2016-06-02 |