GEX · Skin resurfacing

510(k) submissions

Filtered by Skin resurfacing · showing 101–150 of 151

151

K number	Device name	Company	Technology	Class	Decision
K191501	PALLAS 308/311 Solid-State UV Laser SystemSkin resurfacing	Laseroptek Co., Ltd.Korea, Republic of	Other	Class 2	2020-01-03
K192755	Soli-Lite LG4 GalileoAcne treatment	Silhouet-Tone CorporationCanada	LED	Class 2	2019-12-20
K192528	CO2 Laser Therapy SystemSurgical cutting	Shangdong Huamei Technology Co., Ltd.China	CO2	Class 2	2019-12-03
K192331	LaseMD LEO Laser SystemPigment treatment	Lutronic GlobalUnited States	Thulium fiber	Class 2	2019-11-12
K190319	Waterlase Laser System FamilyDental	Biolase, Inc.United States	Er:YAG	Class 2	2019-10-10
K191842	Discovery Pico, Discovery Pico Plus, Discovery Pico DermPigment treatment	Quanta System SpaItaly	Q-Switched	Class 2	2019-09-17
K191685	PicoWay Laser SystemPigment treatment	Candela CorporationUnited States	Picosecond	Class 2	2019-09-16
K191518	CO2 Laser SystemSkin resurfacing	Shenzhen Gsd Tech Co., Ltd.China	CO2	Class 2	2019-09-12
K183563	Holinwon 30Surgical cutting	Wontech Co., Ltd.Korea, Republic of	CO2	Class 2	2019-09-05
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
K182045	Lotus III Multi-Pulsed Er: Yag Laser SystemSurgical cutting	Laseroptek Co., Ltd.Korea, Republic of	Er:YAG	Class 2	2018-12-27
K182270	Cellene CO2 Laser SystemSurgical cutting	Bio-Med USA, Inc.United States	CO2	Class 2	2018-11-02
K182088	XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroSurgical cutting	Fotona D.O.O.Slovenia	Er:YAG	Class 2	2018-10-31
K182669	Youlaser CO2Surgical cutting	Quanta System SpaItaly	CO2	Class 2	2018-10-17
K181867	Deka Smartxide2 TrioSurgical cutting	El.En Electronic Engineering SpaItaly	CO2	Class 2	2018-10-02
K173827	LightScalpelSurgical cutting	Lightscalpel, Inc.United States	CO2	Class 2	2018-09-14
K181523	Syneron CO2RE SystemSurgical cutting	Syneron-CandelaUnited States	CO2	Class 2	2018-07-11
K173359	Fractional CO2 Surgical Laser SystemSkin resurfacing	Ami, Inc.Korea, Republic of	CO2	Class 2	2018-07-05
K180993	Beacon Advanced CO2 Laser SystemSurgical cutting	Omniguide, Inc.United States	CO2	Class 2	2018-06-28
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
K180193	DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto)Skin resurfacing	El.En Electronic Engineering SpaItaly	CO2	Class 2	2018-02-21
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
K172908	Q-Switched Nd:YAG Laser SystemSkin resurfacing	Ami, Inc.Korea, Republic of	Q-Switched	Class 2	2017-12-07
K172362	DEKA SMARTXIDE TOUCHSkin resurfacing	El.En Electronic Engineering SpaItaly	CO2	Class 2	2017-11-17
K172376	Discovery Pico, Discovery Pico PlusSurgical cutting	Quanta System SpaItaly	Q-Switched	Class 2	2017-10-19
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
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
K170850	Alma QVascular treatment	Alma Lasers, Inc.Israel	Q-Switched	Class 2	2017-06-15
K163196	ACTION II Laser SystemSurgical cutting	Lutronic CorporationKorea, Republic of	Er:YAG	Class 2	2017-05-24
K170215	LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDockSkin resurfacing	Patient Pocket, LLCUnited States	CO2	Class 2	2017-04-19
K163222	Discovery Pico FamilyPigment treatment	Quanta System SpaItaly	Q-Switched	Class 2	2016-12-05
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
K161925	CO2 Laser Therapy MachineSurgical cutting	Beijing Adss Development Co., Ltd.China	CO2	Class 2	2016-10-05
K152737	Lite TouchSurgical cutting	Focus Medical, LLCUnited States	Er:YAG	Class 2	2016-06-29
K160480	PicoSure WorkstationPigment treatment	Cynosure, LLCUnited States	Picosecond	Class 2	2016-05-17
K152529	NaturaLase CO2 Laser SystemSurgical cutting	Focus Medical, LLCUnited States	CO2	Class 2	2016-02-04
K152153	MicroSpot HandpieceSkin resurfacing	Asclepion Laser Technologies GmbHUnited States	Er:YAG	Class 2	2015-12-11
K151655	CO2RE SystemSurgical cutting	Syneron Medical, Ltd.United States	CO2	Class 2	2015-09-15
K150140	MCL 31 DermablateSurgical cutting	Asclepion Laser Technologies GmbHUnited States	CO2	Class 2	2015-06-05
K150516	DEKA SYNCHRO REPLA:Y FAMILY OF LASER SYSTEMSHair removal	El.En Electronic Engineering SpaItaly	Alexandrite	Class 2	2015-04-13
K143723	SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroSurgical cutting	Fotona D.D.Slovenia	Er:YAG	Class 2	2015-04-09
K150027	CYMASurgical cutting	Whitecap Technologies, LLCUnited States	CO2	Class 2	2015-04-03
K143105	Picosure WorkstationPigment treatment	Cynosure, LLCUnited States	Picosecond	Class 2	2015-02-23