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Panels › General, Plastic Surgery › Product code GEX · Class 2

Powered Laser Surgical Instrument

Regulation 878.4810

69510(k)s in 12 months (2,892 all time)
6recalls in 12 months (201 all time)
150recalls that name a 510(k)
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Top companies in GEX

Company510(k)sRecalls
Cynosure, Inc.841
Lumenis6011
Sharplan Lasers, Inc.660
Quanta System Spa576
Candela Corp.535
Laserscope490
Trimedyne, Inc.480
Heraeus Lasersonics, Inc.370
Surgical Laser Technologies, Inc.350
Boston Scientific1123
Decided510(k)Device and applicantCode
Oct 19, 2021K212703AcuPulse CO2 Laser System, Delivery Devices and Accessories
Lumenis, Ltd., IL
GEX
Oct 19, 2021K201773PICOHI
Hironic Co., Ltd., KR
GEX
Oct 6, 2021K212082Picore
Bio-Med USA, Inc.
GEX
Sep 20, 2021K203799ProFlex CO2 Laser Fiber
Innovaquartz, LLC
GEX
Sep 3, 2021K211637AROMA GRAND
Daeju Meditech Engineering Co., Ltd., KR
GEX
Sep 1, 2021K210951Leonardo Mini Blue
Ceramoptec GmbH, DE
GEX
Aug 25, 2021K211362SCAR 3
El.En Electronic Engineering Spa, IT
GEX
Jul 30, 2021K211761UltraLase Flexible CO2 Laser Waveguide
W & R Investments, LLC Dba Laser Engineering
GEX
Jul 28, 2021K211335Diode Laser Machine, Model Number: BM-100
Zhengzhou Bestview ST Co., Ltd., CN
GEX
Jul 14, 2021K203728Darwin
Luvo Medical Technologies, Inc., CA
GEX
Jul 6, 2021K211821DEKA Motus AZ
El.En Electronic Engineering Spa, IT
GEX
Jul 2, 2021K203441The Alma Hybrid Laser System
Alma Lasers , Ltd., IL
GEX
Jun 22, 2021K202991Fotona XPulse Pro Laser Platform
Fotona D.O.O., SI
GEX
Jun 4, 2021K202828Surgical Green Laser System
Realton (Suzhou) Medical Technology Co., Ltd., CN
GEX
Jun 3, 2021K211401SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Access
Gyrus Acmi, Inc.
GEX
May 24, 2021K210535UltraLight LED System
Rohrer Aesthetics, LLC
GEX
May 10, 2021K210168Diode Laser Therapy Systems
Beijing Kes Biology Technology Co., Ltd., CN
GEX
Apr 28, 2021K210925Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip La
Boston Scientific
GEX
Apr 27, 2021K210964Resonic Rapid Acoustic Pulse Device
Soliton, Inc.
GEX
Apr 26, 2021K210663Dermatological Diode Laser Systems
Beijing HuaCheng Taike Technology Co., Ltd., CN
GEX
Apr 26, 2021K202258ERISE Laser handpiece
El.En Electronic Engineering Spa, IT
GEX
Apr 23, 2021K202257Dermatological Diode Laser Systems
Zhuolu Jontelaser Manufacturing Technology Co., Ltd., CN
GEX
Apr 23, 2021K202043Secret Duo
Ilooda Co,., Ltd., KR
GEX
Apr 7, 2021K203491PicoLO Nd: YAG Picosecond Laser System
Laseroptek Co., Ltd., KR
GEX
Apr 2, 2021K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable
Leoni Fiber Optics, Inc.
GEX
Mar 30, 2021K210226PicoSure Workstation
Cynosure, LLC
GEX
Mar 26, 2021K203788DermaV Laser System
Lutronic Corporation, KR
GEX
Mar 26, 2021K201466Tranberg CLS Laser Applicator
Clinical Laserthermia Systems, AB, SE
GEX
Mar 19, 2021K202985LightWalker Laser System Family
Fotona D.O.O., SI
GEX
Mar 11, 2021K210142Fiber Dust
Quanta System Spa, IT
GEX
Mar 5, 2021K203054FlexSys
Gme German Medical Engineering GmbH, DE
GEX
Feb 26, 2021K210033Laser Treatment System, Model: NYX and Grace
Canadian Pioneer Medical Technology Corporation, CA
GEX
Feb 26, 2021K202702FLARE Single-Use Surgical Laser Fiber
Realton (Suzhou) Medical Technology Co., Ltd., CN
GEX
Feb 23, 2021K203804Global Med Systems Milesman Compact Laser
Global Med Systems SL, ES
GEX
Jan 29, 2021K201801Rapid Acoustic Pulse Device
Soliton, Inc.
GEX
Jan 22, 2021K193266MIIN
Medico USA, Inc.
GEX
Jan 14, 2021K203241OmniGuide BeamPath OTO-U Fiber
Omniguide, Inc.
GEX
Dec 24, 2020K203544UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories
Lumenis, Ltd., IL
GEX
Dec 17, 2020K201594Primelase Excellence
High Technology Products S.L.U, ES
GEX
Dec 15, 2020K202601Single-use Sterile medical laser fiber
Realton (Suzhou) Medical Technology Co., Ltd., CN
GEX
Nov 30, 2020K201687Avenda Health Treatment System
Avenda Health, Inc.
GEX
Nov 25, 2020K202250Dermatological Carbon Dioxide Laser Systems
Zhuolu Jontelaser Manufacturing Technology Co., Ltd., CN
GEX
Nov 19, 2020K202980Laser Therapy Device
Shenzhen Leaflife Technology Co., Ltd., CN
GEX
Nov 19, 2020K202172StarWalker
Fotona D.O.O., SI
GEX
Nov 19, 2020K200693K2 MOBILE
Hulaser, Inc., KR
GEX
Nov 18, 2020K202503Chrome
Quanta System Spa, IT
GEX
Nov 16, 2020K202758Nd: YAG Laser Therapy Systems HM-YL900
Shangdong Huamei Technology Co., Ltd., CN
GEX
Oct 22, 2020K202428AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories
Lumenis, Ltd., IL
GEX
Oct 15, 2020K202041Opera Evo
Quanta System Spa, IT
GEX
Aug 21, 2020K201056NeuroBlate System
Monteris Medical, Inc.
GEX

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