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GEX

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

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RecordFirmDate
MCL 31 Dermablate System (K210634)Asclepion Laser Technologies GmbH2022-04-13
LED Therapy Device (Planar LED/Planar LED mini) (K220103)Shenzhen Leaflife Technology Co., Ltd.2022-04-12
Finexel (K213557)SNJ Co., Ltd.2022-04-12
AviClear Laser System (K213461)Cutera, Inc.2022-03-24
Fiber Dust PRO (K220426)Quanta System Spa2022-03-16
Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares (K211722)Canadian Pioneer Medical Technology Corporation2022-02-25
HOLLYWOOD SPECTRA Laser System (K213569)Lutronic Corporation2022-02-04
Cryo 7 (K220020)Zimmer Medizinsysteme GmbH2022-02-04
Rosso (K211228)Quanta System Spa2022-02-02
Sentient Manufacturing Laser Fiber (K213554)Sentient Manufacturing , LLC2022-02-02
CO2 Laser Equipment (K212611)Beijing Globalipl Development Co., Ltd.2022-02-01
Platform treatment system (K203395)Shanghai Apolo Medical Technology Co., Ltd.2022-01-28
Dermatological diode laser system (K212478)Beijing Stelle Laser Technology Co., Ltd.2022-01-14
Picocaremajesty (K212127)Wontech Co., Ltd.2022-01-07
Diode Laser System GP900A8, Diode Laser System GP900Q8 (K213225)Shenzhen Gsd Tech Co., Ltd.2021-12-22
Frax 1940 for Nordlys and Frax Pro (K212492)Candela Corporation2021-12-20
S2 Pigment Removal System (K202848)Lightsense Technologies, Ltd.2021-12-14
UltraClear Fractional Laser System (K210847)Fa International, LP2021-12-10
PicoLO Premium (K212573)Laseroptek Co., Ltd.2021-12-08
OxyLight 2.0 (K202175)Raja Trading Company, Inc.2021-12-02
Finebeam (K202288)SNJ Co., Ltd.2021-11-19
Darwin (K212607)Luvo Medical Technologies, Inc.2021-11-15
Diode laser therapy system (K212978)Beijing Unt Technology Co., Ltd.2021-11-10
Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT Thulium Fiber Laser, Thulium Fiber Laser 1940 nm, Optica XT Thulium Fiber Laser 1940 nm, Optica XT 60 Thulium Fiber Laser 1940 nm, Optica XT Superpulse Thulium Fiber Laser 1940 nm, OptiLITE Laser Fibers and Accessories (K211517)Convergent Laser Technologies2021-11-09
Resonic Rapid Acoustic Pulse Device (K212502)Soliton, Inc.2021-11-05
Vydence Zye and Vydence One (K202998)Vydence Medical Industria E Comercio Ltda2021-10-26
Medical Diode Laser Systems (K211977)Wuhan Dimed Laser Technology Co., Ltd.2021-10-26
Laser Treatment System, Model: Hera, Armo (K212793)Canadian Pioneer Medical Technology Corporation2021-10-25
CO2 Laser Machine, Model: BW-203B (K211735)Zhengzhou Bestview ST Co., Ltd.2021-10-22
DEKA LipoAI (K212270)El.En Electronic Engineering Spa2021-10-21
PICOHI (K201773)Hironic Co., Ltd.2021-10-19
AcuPulse CO2 Laser System, Delivery Devices and Accessories (K212703)Lumenis, Ltd.2021-10-19
Picore (K212082)Bio-Med USA, Inc.2021-10-06
ProFlex CO2 Laser Fiber (K203799)Innovaquartz, LLC2021-09-20
AROMA GRAND (K211637)Daeju Meditech Engineering Co., Ltd.2021-09-03
Leonardo Mini Blue (K210951)Ceramoptec GmbH2021-09-01
SCAR 3 (K211362)El.En Electronic Engineering Spa2021-08-25
UltraLase Flexible CO2 Laser Waveguide (K211761)W & R Investments, LLC Dba Laser Engineering2021-07-30
Diode Laser Machine, Model Number: BM-100 (K211335)Zhengzhou Bestview ST Co., Ltd.2021-07-28
Darwin (K203728)Luvo Medical Technologies, Inc.2021-07-14
DEKA Motus AZ (K211821)El.En Electronic Engineering Spa2021-07-06
The Alma Hybrid Laser System (K203441)Alma Lasers , Ltd.2021-07-02
Fotona XPulse Pro Laser Platform (K202991)Fotona D.O.O.2021-06-22
Surgical Green Laser System (K202828)Realton (Suzhou) Medical Technology Co., Ltd.2021-06-04
SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) (K211401)Gyrus Acmi, Inc.2021-06-03
UltraLight LED System (K210535)Rohrer Aesthetics, LLC2021-05-24
Diode Laser Therapy Systems (K210168)Beijing Kes Biology Technology Co., Ltd.2021-05-10
Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser Fiber (K210925)Boston Scientific2021-04-28
Resonic Rapid Acoustic Pulse Device (K210964)Soliton, Inc.2021-04-27
Dermatological Diode Laser Systems (K210663)Beijing HuaCheng Taike Technology Co., Ltd.2021-04-26
ERISE Laser handpiece (K202258)El.En Electronic Engineering Spa2021-04-26
Secret Duo (K202043)Ilooda Co,., Ltd.2021-04-23
Dermatological Diode Laser Systems (K202257)Zhuolu Jontelaser Manufacturing Technology Co., Ltd.2021-04-23
PicoLO Nd: YAG Picosecond Laser System (K203491)Laseroptek Co., Ltd.2021-04-07
LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable (K201171)Leoni Fiber Optics, Inc.2021-04-02
PicoSure Workstation (K210226)Cynosure, LLC2021-03-30
DermaV Laser System (K203788)Lutronic Corporation2021-03-26
Tranberg CLS Laser Applicator (K201466)Clinical Laserthermia Systems, AB2021-03-26
LightWalker Laser System Family (K202985)Fotona D.O.O.2021-03-19
Fiber Dust (K210142)Quanta System Spa2021-03-11
FlexSys (K203054)Gme German Medical Engineering GmbH2021-03-05
Laser Treatment System, Model: NYX and Grace (K210033)Canadian Pioneer Medical Technology Corporation2021-02-26
FLARE Single-Use Surgical Laser Fiber (K202702)Realton (Suzhou) Medical Technology Co., Ltd.2021-02-26
Global Med Systems Milesman Compact Laser (K203804)Global Med Systems SL2021-02-23
Rapid Acoustic Pulse Device (K201801)Soliton, Inc.2021-01-29
MIIN (K193266)Medico USA, Inc.2021-01-22
OmniGuide BeamPath OTO-U Fiber (K203241)Omniguide, Inc.2021-01-14
UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories (K203544)Lumenis, Ltd.2020-12-24
Primelase Excellence (K201594)High Technology Products S.L.U2020-12-17
Single-use Sterile medical laser fiber (K202601)Realton (Suzhou) Medical Technology Co., Ltd.2020-12-15
Avenda Health Treatment System (K201687)Avenda Health, Inc.2020-11-30
Dermatological Carbon Dioxide Laser Systems (K202250)Zhuolu Jontelaser Manufacturing Technology Co., Ltd.2020-11-25
Laser Therapy Device (K202980)Shenzhen Leaflife Technology Co., Ltd.2020-11-19
K2 MOBILE (K200693)Hulaser, Inc.2020-11-19
StarWalker (K202172)Fotona D.O.O.2020-11-19
Chrome (K202503)Quanta System Spa2020-11-18
Nd: YAG Laser Therapy Systems HM-YL900 (K202758)Shangdong Huamei Technology Co., Ltd.2020-11-16
AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories (K202428)Lumenis, Ltd.2020-10-22
Opera Evo (K202041)Quanta System Spa2020-10-15
NeuroBlate System (K201056)Monteris Medical, Inc.2020-08-21
Picowon (K201406)Wontech Co., Ltd.2020-07-22
AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories (K201663)Lumenis, Ltd.2020-07-16
CO2 Laser Therapy System (K201109)Shanghai Apolo Medical Technology Co., Ltd.2020-07-15
Litho 150, Cyber Ho 150 (K201455)Quanta System Spa2020-06-30
Stardust Med (K200736)I.T.S. Group S.R.L.2020-06-26
Nd: YAG Laser Therapy Systems (K193477)Beijing Kes Biology Technology Co., Ltd.2020-06-24
Venus Epileve (K200786)Venus Concept USA, Inc.2020-06-09
CO2 Laser System (K200042)Beijing Superlaser Technology Co., Ltd.2020-06-09
Oxylight (K200104)Raja Trading Company, Inc.2020-06-04
PicoSecond Nd: YAG Laser System (K200116)Shanghai Apolo Medical Technology Co., Ltd.2020-05-28
Medical Diode Laser Hair Removal System (K200525)Weifang Mingliang Electronics Co., Ltd.2020-05-27
GentleMax Pro Plus (K201111)Candela Corporation2020-05-26
Photodynamic Therapy (PDT) Equipment (K200751)Shangdong Huamei Technology Co., Ltd.2020-05-21
Dermalux Tri-Wave MD (K200659)Aesthetic Technology, Ltd.2020-05-09
MT One (K192856)M&T S.R.L.2020-04-24
Diode Laser Therapy Device (K200118)Shanghai Apolo Medical Technology Co., Ltd.2020-04-17
ND:YAG Laser (K193464)Beijing Superlaser Technology Co., Ltd.2020-04-13
Diode Laser Hair Removal System (K191970)Beijing Sano Laser S&T Development Co.,Ltd2020-04-06
Diode Laser Hair Removal Machine (K192735)Beijing Lead Beauty S & T Co., Ltd.2020-04-03
SkyPulse (K193656)Fotona D.O.O.2020-03-27
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