510(k) submissions
Filtered by Vascular treatment · showing 151–200 of 220
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K183563 | Holinwon 30Surgical cutting | Wontech Co., Ltd.Korea, Republic of | CO2 | Class 2 | 2019-09-05 |
| K183122 | 810nm Diode Laser SystemHair removal | Shanghai Wonderful Opto-Electrics Tech.Co.,LtdChina | Diode | Class 2 | 2019-08-25 |
| K191349 | 980nm Diode Laser Therapy DeviceSurgical cutting | Shanghai Apolo Medical Technology Co., Ltd.China | Diode | Class 2 | 2019-08-16 |
| K183647 | SOLTIVE™ Laser System(SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Accessories)Surgical cutting | Olympus Surgical Technologies AmericaUnited States | Thulium fiber | Class 2 | 2019-08-09 |
| K190938 | Phototherapy SystemAcne treatment | Shanghai Apolo Medical Technology Co., Ltd.China | LED | Class 2 | 2019-06-26 |
| K190936 | Q-Switched Nd: YAG Laser SystemPigment treatment | Shanghai Apolo Medical Technology Co., Ltd.China | Nd:YAG | Class 2 | 2019-06-17 |
| K183199 | TRIO HandpieceSurgical cutting | Omniguide, Inc.United States | CO2 | Class 2 | 2019-05-02 |
| K182173 | Joule SystemPigment treatment | Sciton, IncUnited States | Thulium fiber | Class 2 | 2019-03-06 |
| K190007 | Vydence Laser FamilyAcne treatment | Vydence Medical Industria E Comercio LtdaBrazil | Other | Class 2 | 2019-03-01 |
| K183452 | Vbeam Prima Laser SystemVascular treatment | Candela CorporationUnited States | Nd:YAG | Class 2 | 2019-02-01 |
| K183307 | Magma Spark Pro (Magma Spark Plus, Alpha)Hair removal | Formatk Systems , Ltd.Israel | Diode | Class 2 | 2018-12-11 |
| K181632 | Venacure 1470 ProVascular treatment | Quanta System SpaItaly | Diode | Class 2 | 2018-09-17 |
| 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 |
| 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 |
| K180508 | JOULE SYSTEMSkin resurfacing | Sciton, IncUnited States | CO2 | Class 2 | 2018-05-18 |
| K180224 | ELEMENT-TLVascular treatment | Elemenic Co., Ltd.Korea, Republic of | Other | Class 2 | 2018-03-15 |
| 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 |
| K173285 | JOULE SYSTEMSkin resurfacing | Sciton, IncUnited States | Er:YAG | Class 2 | 2018-01-29 |
| K173002 | 2940 nm Er:Yag Laser HandpieceSkin resurfacing | Quanta System SpaItaly | Er:YAG | Class 2 | 2017-12-13 |
| K173038 | CuRAS Nd:YAG LaserSurgical cutting | Ilooda Co,., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2017-12-01 |
| K172639 | PALLAS 308/311 Solid-State UV Laser SystemPigment treatment | Laseroptek Co., Ltd.Korea, Republic of | Other | Class 2 | 2017-11-03 |
| 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 |
| 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 |
| 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 |
| K170060 | M22 and ResurFx SystemsSkin resurfacing | Lumenis, Inc.Israel | Other | Class 2 | 2017-08-09 |
| 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 |
| K170850 | Alma QVascular treatment | Alma Lasers, Inc.Israel | Q-Switched | Class 2 | 2017-06-15 |
| 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 |
| K170718 | Iridex TruFocus LIO PremiereVascular treatment | Iridex CorporationUnited States | Other | Class 2 | 2017-05-03 |
| K160549 | MEDICAL DIODE LASER SYSTEMSVascular treatment | Wuhan Gigaa Optronics Technology Co., Ltd.China | Diode | Class 2 | 2017-04-07 |
| 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 |
| K162191 | NAVILAS Laser SystemVascular treatment | Od-Os GmbHUnited States | Other | Class 2 | 2016-11-22 |
| K162914 | VenaCure EVLT NeverTouch Procedure KitVascular treatment | AngioDynamics, Inc.United States | Diode | Class 2 | 2016-11-16 |
| K160488 | Cutera enlighten III Laser SystemPigment treatment | Cutera, Inc.United States | Q-Switched | Class 2 | 2016-10-28 |
| 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 |
| K153124 | DuraLazeTM HoLEP Laser FiberSurgical cutting | Medkey, LLCUnited States | Other | Class 2 | 2016-07-26 |
| K152667 | ATOVEN-Reusable Laser FiberVascular treatment | Diotech COKorea, Republic of | Diode | Class 2 | 2016-06-09 |
| K160952 | Alma Diode Tabletop LaserVascular treatment | Alma, Ltd.United States | Diode | Class 2 | 2016-05-05 |
| K160227 | ACCENTO / HWA Dual/Single laserHair removal | Bison Medical Co, Ltd.Korea, Republic of | Alexandrite | Class 2 | 2016-04-22 |