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GEX

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

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RecordFirmDate
SIROLaser Blue (K180044)Dentsply Sirona2018-03-08
LMT-3000 (K172818)Lameditech Co. , Ltd.2018-03-07
Dornier Medilas H Solvo 35 Laser (K180350)Dornier Medtech America2018-03-07
InMode VLaze (K173677)Inmode MD , Ltd.2018-02-23
LightForce LTS Model 1000, 1500, 2500, and 4000 (K173067)Litecure, LLC2018-02-22
DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto) (K180193)El.En Electronic Engineering Spa2018-02-21
Surgical Laser fibers (K180158)Quanta System Spa2018-02-14
Siberian Fit (K172439)Vydence2018-02-14
PicoSure Workstation (K173199)Cynosure, Inc.2018-02-07
JOULE SYSTEM (K173285)Sciton, Inc2018-01-29
Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules (K172193)Alma Lasers, Inc.2018-01-09
2940 nm Er:Yag Laser Handpiece (K173002)Quanta System Spa2017-12-13
Q-Switched Nd:YAG Laser System (K172908)Ami, Inc.2017-12-07
LightWalker Laser System Family (K172819)Fotona D.O.O.2017-12-01
CuRAS Nd:YAG Laser (K173038)Ilooda Co,., Ltd.2017-12-01
Epic Pro 940 (K172771)Biolase, Inc.2017-11-29
Rapid Family (K173169)Sharplight Technologies, Ltd.2017-11-20
DEKA SMARTXIDE ULTRASPEED (K172363)El.En Electronic Engineering Spa2017-11-17
DEKA SMARTXIDE TOUCH (K172362)El.En Electronic Engineering Spa2017-11-17
NeuroBlate System (K173305)Monteris Medical,2017-11-17
PALLAS 308/311 Solid-State UV Laser System (K172639)Laseroptek Co., Ltd.2017-11-03
Cutera enlighten III Laser System (K172077)Cutera, Inc.2017-10-27
Rhapsody H-30 Holmium Laser System (K172325)Cook Incorporated2017-10-26
NeuroBlate System (K172881)Monteris Medical,2017-10-20
Discovery Pico, Discovery Pico Plus (K172376)Quanta System Spa2017-10-19
585 (K172198)Quanta System Spa2017-10-17
MT ONE (K172413)M&T S.R.L.2017-10-06
Sterling Supreme Diode Laser (K171986)CAO Group, Inc.2017-09-22
LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity (K170179)Lumenis, Ltd.2017-09-18
PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System (K170409)Topcon Medical Laser Systems, Inc. (Tmls)2017-09-12
BM.IRIS (K171648)Bluecore Co., Ltd.2017-09-08
Epilaser (K170970)Epilady 2000, LLC2017-09-01
VenaCure EVLT NeverTouch Procedure Kit (K171921)AngioDynamics, Inc.2017-08-24
StarWalker (K171227)Fotona D.O.O.2017-08-18
M22 and ResurFx Systems (K170060)Lumenis, Ltd.2017-08-09
Fraxis (K172096)Ilooda Co,., Ltd.2017-08-09
InMode Diolaze XL (K170738)Inmode MD , Ltd.2017-08-07
Q-Switched Nd:YAG Laser System (K171079)Ids, Ltd.2017-08-01
Litho 60 (K172025)Quanta System Spa2017-07-31
Discovery Pico, Discovery Pico Plus (K171945)Quanta System Spa2017-07-28
Photodynamic Therapy Device (K170187)Uvbiotek, LLC2017-07-28
LightMed Dental Laser System (K170073)Lightmed Dentaltechnology Corp.2017-07-25
Monteris Medical NeuroBlate System (K171255)Monteris Medical, Inc.2017-07-25
Thunder, Thunder VT, Thunder HR (K171711)Quanta System Spa2017-07-07
LASEMD Laser System (K171009)Lutronic Corporation2017-06-23
HyPHo Laser System (K163449)Hyper Photonics Srl2017-06-23
DEKA MOTUS AX (K162886)El.En Electronic Engineering Spa2017-06-19
Diode Laser Hair Removal System (K162659)Shandong Huamei Technology Co., Ltd.2017-06-16
Alma Q (K170850)Alma Lasers , Ltd.2017-06-15
Picocare (K162755)Wontech Co., Ltd.2017-06-12
Laser Peripherals, LLC Family of Bare Laser Fibers (K170366)Laser Peripherals, LLC2017-06-08
Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece (K170626)Alma Lasers, Inc.2017-05-31
PicoWay Laser System (K170597)Syneron Candela Corporation2017-05-25
ACTION II Laser System (K163196)Lutronic Corporation2017-05-24
Cook Holmium Laser Fiber (K163197)Cook Incorporated2017-05-24
Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories (K170121)Lumenis, Ltd.2017-05-22
MICRORUPTOR 6 (K160677)Meridian AG2017-05-19
SIROLaser Advance+ (K170500)Dentsply Sirona2017-05-16
Dental 5 Multi Diode laser (K163638)Bio-Med USA, Inc.2017-05-15
Venus Silk.expert (K170734)Cyden Limited2017-05-08
Iridex TruFocus LIO Premiere (K170718)Iridex Corporation2017-05-03
U.S. Laser Worx Patriot 1 family of lasers (K162334)U.S. Laser Worx2017-04-27
Cutera enlighten III Laser System (K170936)Cutera, Inc.2017-04-25
LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDock (K170215)Patient Pocket, LLC2017-04-19
MEDICAL DIODE LASER SYSTEMS (K160549)Wuhan Gigaa Optronics Technology Co., Ltd.2017-04-07
NeuroBlate System (K170724)Monteris Medical,2017-04-07
MultiPulse HoPLUS (K161257)Asclepion Laser Technologies GmbH2017-03-31
LIGHTFUSION LED SYSTEM (K162556)Vitage Led, Ltd.2017-03-24
Tranberg CLS Diffusor Laser Fiber (K163103)Clinical Laserthermia Systems, AB2017-03-23
Sparkling (K163655)Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd2017-03-17
Cyber Ho (K170331)Quanta System Spa2017-03-03
Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532™ Laser System (K162837)Lumenis, Ltd.2017-02-28
ND YAG Q-switch Laser Therapy Machine (K161926)Beijing Adss Development Co., Ltd.2017-02-22
Q-Switched Nd:YAG Laser Therapy Systems (K163123)Beijing Sincoheren Science and Technology Development Co.2017-02-02
PicoWay Laser System (K162454)Syneron Candela Corporation2017-02-01
eLyx-PRO (K162851)Intelligent Sensory Concept SA2017-01-24
Venus Velocity Diode Laser System (K162765)Venus Concept , Ltd.2017-01-11
Epic Pro (K163128)Biolase, Inc.2017-01-11
Photon, Photon Plus (K162114)Zolar Technology & Mfg Co., Inc.2016-12-12
FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag) (K161632)Bios S.R.L.2016-12-08
Discovery Pico Family (K163222)Quanta System Spa2016-12-05
Litho (K163009)Quanta System Spa2016-12-01
NAVILAS Laser System (K162191)Od-Os GmbH2016-11-22
V30 system, V-Form Handpiece BC Medium applicator (K162363)Viora , Ltd.2016-11-18
VenaCure EVLT NeverTouch Procedure Kit (K162914)AngioDynamics, Inc.2016-11-16
Diode Laser Therapy Machine (K161692)Beijing Adss Development Co., Ltd.2016-11-16
Magma Spark (K162781)Formatk Systems , Ltd.2016-11-09
Lucid Q-PTP / HWA 55 (K161670)Bison Medical Co, Ltd.2016-11-02
FRAXIS DUO (K160312)Ilooda Co,., Ltd.2016-10-28
Cutera enlighten III Laser System (K160488)Cutera, Inc.2016-10-28
EdgeOne CO2 Laser (K162169)Jeisys Medical, Inc.2016-10-27
NeuroBlate System (K162762)Monteris Medical, Inc.2016-10-26
Olive Plus (K161981)Ama Network, Inc.2016-10-14
CO2 Laser Therapy Machine (K161925)Beijing Adss Development Co., Ltd.2016-10-05
IRIDEX Cyclo G6 Laser System, G-Probe Illuminate (K162416)Iridex Corporation2016-09-29
LUCERNA Dental Laser (K161185)Viax Dental Lab2016-09-26
Sterling 5W Diode Laser (K160413)CAO Group, Inc.2016-09-21
Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra (K161162)Ellipse A/S2016-09-16
Matrix LS-40 CO2 Laser System (K161356)Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd2016-09-09
ORION (K161503)Yerim Engineering Co., Ltd.2016-08-26
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