510(k) submissions
Filtered by Pigment treatment · showing 151–195 of 195
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| 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 |
| K172077 | Cutera enlighten III Laser SystemPigment treatment | Cutera, Inc.United States | Nd:YAG | Class 2 | 2017-10-27 |
| 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 |
| K171648 | BM.IRISSurgical cutting | BLUECORE COMPANY Co., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2017-09-08 |
| 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 |
| K171079 | Q-Switched Nd:YAG Laser SystemPigment treatment | Ids, LimitedKorea, Republic of | Q-Switched | Class 2 | 2017-08-01 |
| K171945 | Discovery Pico, Discovery Pico PlusSurgical cutting | Quanta System SpaItaly | Q-Switched | Class 2 | 2017-07-28 |
| K171009 | LASEMD Laser SystemPigment treatment | Lutronic CorporationKorea, Republic of | Other | Class 2 | 2017-06-23 |
| K162755 | PicocarePigment treatment | Wontech Co., Ltd.Korea, Republic of | Q-Switched | Class 2 | 2017-06-12 |
| K170597 | PicoWay Laser SystemPigment treatment | Syneron-CandelaUnited States | Picosecond | Class 2 | 2017-05-25 |
| K170936 | Cutera enlighten III Laser SystemPigment treatment | Cutera, Inc.United States | Nd:YAG | Class 2 | 2017-04-25 |
| 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 |
| K163222 | Discovery Pico FamilyPigment treatment | Quanta System SpaItaly | Q-Switched | Class 2 | 2016-12-05 |
| 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 |
| 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 |
| K160607 | PicoWay Laser SystemPigment treatment | Syneron-CandelaUnited States | Picosecond | Class 2 | 2016-07-05 |
| K160480 | PicoSure WorkstationPigment treatment | Cynosure, LLCUnited States | Picosecond | Class 2 | 2016-05-17 |
| K160227 | ACCENTO / HWA Dual/Single laserHair removal | Bison Medical Co, Ltd.Korea, Republic of | Alexandrite | Class 2 | 2016-04-22 |
| K153229 | SuperbiumVascular treatment | Bios S.R.L.Italy | Nd:YAG | Class 2 | 2016-04-12 |
| K160368 | EVO platformVascular treatment | Quanta System SpaItaly | Q-Switched | Class 2 | 2016-04-05 |
| K153527 | PicoWay Laser SystemPigment treatment | Syneron-CandelaUnited States | Picosecond | Class 2 | 2016-03-02 |
| K152611 | V20 systemAcne treatment | Viora , Ltd.Israel | Other | Class 2 | 2016-02-19 |
| K150997 | RUBY STARPigment treatment | Bison Medical Co, Ltd.Korea, Republic of | Ruby | Class 2 | 2015-12-22 |
| K152714 | Quanta ForteHair removal | Quanta System SpaItaly | Diode | Class 2 | 2015-12-21 |
| K152012 | EVO platformVascular treatment | Quanta System SpaItaly | Q-Switched | Class 2 | 2015-12-08 |
| K151473 | NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and Pulse Slicing ModulePigment treatment | Focus Medical, LLCUnited States | Q-Switched | Class 2 | 2015-09-01 |
| K151232 | VIKINI Diode Laser SystemHair removal | Ilooda Co,., Ltd.Korea, Republic of | Diode | Class 2 | 2015-08-06 |
| K140386 | LUMINA 24Pigment treatment | Rogers Sciences, Inc.United States | Other | Class 2 | 2015-05-26 |
| K150326 | PicoWay Laser SystemPigment treatment | Candela CorporationUnited States | Picosecond | Class 2 | 2015-04-16 |
| K150516 | DEKA SYNCHRO REPLA:Y FAMILY OF LASER SYSTEMSHair removal | El.En Electronic Engineering SpaItaly | Alexandrite | Class 2 | 2015-04-13 |
| K143519 | The MeDioStar NeXT FamilyVascular treatment | Asclepion Laser Technologies GmbHUnited States | Diode | Class 2 | 2015-03-10 |
| K150336 | Photonica ProfessionalVascular treatment | Ward Photonics, LLCUnited States | Other | Class 2 | 2015-02-24 |
| K143105 | Picosure WorkstationPigment treatment | Cynosure, LLCUnited States | Picosecond | Class 2 | 2015-02-23 |
| K142924 | Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System FamilyPigment treatment | Shaser, Inc.United States | Other | Class 2 | 2015-02-13 |
| K141986 | ELUX 810 LASERHair removal | Equipmed North America, Inc.United States | Diode | Class 2 | 2015-01-30 |
| K142860 | Lumenis M22 SystemPigment treatment | Lumenis, Inc.United States | Other | Class 2 | 2015-01-21 |
| K143154 | IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe(RFID)Surgical cutting | Iridex CorporationUnited States | Other | Class 2 | 2015-01-02 |