510(k) submissions
Filtered by Other · showing 51–100 of 124
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| 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 |
| 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 |
| K173169 | Rapid FamilyHair removal | Sharplight Technologies, Ltd.Israel | Other | Class 2 | 2017-11-20 |
| K172639 | PALLAS 308/311 Solid-State UV Laser SystemPigment treatment | Laseroptek Co., Ltd.Korea, Republic of | Other | Class 2 | 2017-11-03 |
| K172325 | Rhapsody H-30 Holmium Laser SystemSurgical cutting | Cook IncorporatedUnited States | Other | Class 2 | 2017-10-26 |
| K172198 | 585Vascular treatment | Quanta System SpaItaly | Other | Class 2 | 2017-10-17 |
| K170409 | PASCAL Synthesis Twinstar Ophthalmic Scanning Laser SystemVascular treatment | Topcon Medical Laser Systems, Inc. (Tmls)United States | Other | Class 2 | 2017-09-12 |
| K171921 | VenaCure EVLT NeverTouch Procedure KitVascular treatment | AngioDynamics, Inc.United States | Other | Class 2 | 2017-08-24 |
| K170060 | M22 and ResurFx SystemsSkin resurfacing | Lumenis, Inc.Israel | Other | Class 2 | 2017-08-09 |
| K172025 | Litho 60Surgical cutting | Quanta System SpaItaly | Other | Class 2 | 2017-07-31 |
| 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 |
| 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 |
| K170366 | Laser Peripherals, LLC Family of Bare Laser FibersSurgical cutting | Laser Peripherals, LLCUnited States | Other | Class 2 | 2017-06-08 |
| K163197 | Cook Holmium Laser FiberSurgical cutting | Cook IncorporatedUnited States | Other | 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 |
| 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 |
| 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 |
| K162851 | eLyx-PROAcne treatment | Intelligent Sensory Concept SASwitzerland | Other | Class 2 | 2017-01-24 |
| K162114 | Photon, Photon PlusSurgical cutting | Zolar Technology & Mfg Co., Inc.Canada | Other | Class 2 | 2016-12-12 |
| 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 |
| K162416 | IRIDEX Cyclo G6 Laser System, G-Probe IlluminateSurgical cutting | Iridex CorporationUnited States | Other | Class 2 | 2016-09-29 |
| 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 |
| 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 |
| 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 |
| K151855 | SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral Firing FiberSurgical cutting | Surgical Laser IncorporatedUnited States | Other | Class 2 | 2016-04-15 |
| K153564 | PURE CRYOGENHair removal | Air Liquide Healthcare America CorporationUnited States | Other | Class 2 | 2016-03-29 |
| K160513 | Quanta System Surgical Laser fibersSurgical cutting | Quanta System SpaItaly | Other | Class 2 | 2016-03-18 |
| K160392 | Novilase Laser Therapy System, Model LTS-2Surgical cutting | Novian Health, Inc.United States | Other | Class 2 | 2016-02-26 |