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GEX

2,872 FDA 510(k) clearances · Product code

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RecordFirmDate
Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun (K192951)Ellipse A/S2020-03-26
LightWalker Laser System Family (K193661)Fotona D.O.O.2020-03-25
Q Switched Nd: YAG Laser machine (K193609)Beijing Lead Beauty S & T Co., Ltd.2020-03-20
Wolf445nm (K192272)A.R.C Laser GmbH2020-03-17
SANDRO Dual (K200110)Wontech Co., Ltd.2020-03-16
Epic 980 (K193486)Biolase, Inc.2020-03-16
MeDioStar (K192483)Asclepion Laser Technologies GmbH2020-03-13
elysion-pro (K193367)High Technology Products S.L.U2020-03-12
Bare: 808 (K193446)Luvo Medical Technologies, Inc.2020-03-10
Rapid Acoustic Pulse Device (K200331)Soliton, Inc.2020-03-10
Elite iQ (K193426)Cynosure, LLC2020-03-09
Surgical laser fibers (K200234)Quanta System Spa2020-02-25
Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60 (K192600)Quanta System Spa2020-02-21
Gemini 810+980 Soft Tissue Laser (K192617)Azena Medical, LLC2020-02-20
PicoLazer Laser System (K192583)Rohrer Aesthetics, LLC2020-01-17
Stellar M22 for Intense Pulsed Light (IPL) and Laser System (K193500)Lumenis, Ltd.2020-01-16
XTRAC Momentum Excimer Laser System (K193478)Strata Skin Sciences, Inc.2020-01-14
NeuroBlate System (K193375)Monteris Medical,2020-01-03
PALLAS 308/311 Solid-State UV Laser System (K191501)Laseroptek Co., Ltd.2020-01-03
Litho Evo (K192990)Quanta System Spa2019-12-20
Soli-Lite LG4 Galileo (K192755)Silhouet-Tone Corporation2019-12-20
Deka Luxea (K192539)El.En Electronic Engineering Spa2019-12-16
Diode Laser Therapy System (K192569)San HE Lefis Electronics Co., Ltd.2019-12-13
Diode Laser 808nm (K192516)Beijing Superlaser Technology Co., Ltd.2019-12-10
Vitra 2 (K191962)Quantel Medical2019-12-05
Epic 980 (K192430)Biolase, Inc.2019-12-04
CO2 Laser Therapy System (K192528)Shangdong Huamei Technology Co., Ltd.2019-12-03
TwinScan 808/755 Laser System (K192269)Gme German Medical Engineering GmbH2019-11-19
LaseMD LEO Laser System (K192331)Lutronic Global2019-11-12
BC-5 (K191693)Reveallux, Corp2019-11-01
MT One Diamond (K191942)M&T S.R.L.2019-10-17
Waterlase Laser System Family (K190319)Biolase, Inc.2019-10-10
Discovery Pico, Discovery Pico Plus, Discovery Pico Derm (K191842)Quanta System Spa2019-09-17
PicoWay Laser System (K191685)Candela Corporation2019-09-16
CO2 Laser System (K191518)Shenzhen Gsd Tech Co., Ltd.2019-09-12
Sterling Supreme Diode Laser (K181614)CAO Group, Inc.2019-09-10
Pioneer Elite Diode Laser (K181602)CAO Group, Inc.2019-09-10
Precise SHP Diode Laser (K181601)CAO Group, Inc.2019-09-09
EVO Platform (K192160)Quanta System Spa2019-09-06
Holinwon 30 (K183563)Wontech Co., Ltd.2019-09-05
LightWalker Laser System Family (K191554)Fotona D.O.O.2019-08-30
810nm Diode Laser System (K183122)Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd2019-08-25
980nm Diode Laser Therapy Device (K191349)Shanghai Apolo Medical Technology Co., Ltd.2019-08-16
SOLTIVE™ Laser System(SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Accessories) (K183647)Olympus Surgical Technologies America2019-08-09
Primelase Excellence (K191321)High Technology Products S.L.U2019-08-02
Diode Laser Therapy Systems (K191611)Wingderm Electro-Optics , Ltd.2019-07-31
PerioLase Nd:YAG Pulsed Dental Laser System (K182930)Millennium Dental Technologies, Inc.2019-07-12
EpiLaze Multi-wavelength Laser (K191162)Rohrer Aesthetics, LLC2019-07-09
Phototherapy System (K190938)Shanghai Apolo Medical Technology Co., Ltd.2019-06-26
Q-Switched Nd: YAG Laser System (K190936)Shanghai Apolo Medical Technology Co., Ltd.2019-06-17
CLARITY II Laser System (K183566)Lutronic Corporation2019-06-14
Soliton Acoustic Wave Device (K190542)Soliton, Inc.2019-05-24
TRIO Handpiece (K183199)Omniguide, Inc.2019-05-02
V-Laser (K183156)Wontech Co., Ltd.2019-04-24
Diode Laser Treatment System (K182924)Weifang KM Electronics Co., Ltd.2019-04-15
WaveLight FS200 Patient Interface (K190392)Alcon Laboratories, Inc.2019-03-26
Joule System (K182173)Sciton, Inc2019-03-06
Vydence Laser Family (K190007)Vydence Medical Industria E Comercio Ltda2019-03-01
Vbeam Prima Laser System (K183452)Candela Corp.2019-02-01
PicoLO Nd:YAG Picosecond Laser System (K183392)Laseroptek Co., Ltd.2019-01-04
Lotus III Multi-Pulsed Er: Yag Laser System (K182045)Laseroptek Co., Ltd.2018-12-27
enlighten III Laser System (K182997)Cutera, Inc.2018-12-12
Magma Spark Pro (Magma Spark Plus, Alpha) (K183307)Formatk Systems , Ltd.2018-12-11
SabreLine and SabreGuard Laser Fibers (K182831)Coloplast Corp.2018-12-10
Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System (K182663)Finemec Co., Ltd.2018-11-30
New Era (K182604)Step UP Skin Laser, LLC2018-11-14
Cellene CO2 Laser System (K182270)Bio-Med USA, Inc.2018-11-02
XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro (K182088)Fotona D.O.O.2018-10-31
Youlaser CO2 (K182669)Quanta System Spa2018-10-17
NeuroBlate System (K182036)Monteris Medical,2018-10-15
Deka Smartxide2 Trio (K181867)El.En Electronic Engineering Spa2018-10-02
Venacure 1470 Pro (K181632)Quanta System Spa2018-09-17
LightScalpel (K173827)Lightscalpel, LLC2018-09-14
A-FIT (K173676)Hironic Co., Ltd.2018-09-14
Iridex TruFocus LIO Premiere (K181662)Iridex Corporation2018-09-05
ECHOLASER X4 (K181510)El.En Electronic Engineering Spa2018-09-04
DEKA Motus AY (K181486)El.En Electronic Engineering Spa2018-08-30
MMD Tip (K181480)Strata Skin Sciences, Inc.2018-08-01
Picocare Family (K181272)Wontech Co., Ltd.2018-07-31
Laser Ureteral Catheter (K181431)Cook Incorporated2018-07-30
GME LinScan Lite 808 Laser System (K180518)Gme German Medical Engineering GmbH2018-07-23
Diode Laser System (K181019)Guangzhou Huafei Tongda Technology Co., Ltd.2018-07-16
Dental Diode Laser System (K180967)Lazon Medical Laser Co., Ltd.2018-07-11
Syneron CO2RE System (K181523)Syneron-Candela Corp2018-07-11
Fractional CO2 Surgical Laser System (K173359)Ami, Inc.2018-07-05
400um Perforator and Accessory Vein Ablation Kit (K181044)AngioDynamics, Inc.2018-07-05
Beacon Advanced CO2 Laser System (K180993)Omniguide, Inc.2018-06-28
PICOPLUS Laser System (K173700)Lutronic Corporation2018-06-19
InMode Diolaze System (K180719)Inmode MD , Ltd.2018-06-14
Vbeam Prima Laser System (K180593)Syneron-Candela2018-06-05
JOULE SYSTEM (K180508)Sciton, Inc2018-05-18
Empower H100, Cyber Ho 100, Litho 100 (K180922)Quanta System Spa2018-05-08
Etherea MX (K171443)Vydence Medical Industria E Comercio Ltda2018-04-20
ProFlex Laser Fibers (K180140)Innovaquartz, LLC2018-04-20
Diode laser hair removal device (K180353)Zhengzhou PZ Laser Slim Technology Co., Ltd.2018-04-17
AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO (K180597)Lumenis, Ltd.2018-04-03
Empower H35 (K180426)Quanta System Spa2018-03-16
Ellipse Ydun (K180406)Ellipse A/S2018-03-15
ELEMENT-TL (K180224)Elemenic Co., Ltd.2018-03-15
Empower H65 (K180423)Quanta System Spa2018-03-15
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