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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
Jul 22, 2020K201406Picowon
Wontech Co., Ltd., KR
GEX
Jul 16, 2020K201663AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories
Lumenis, Ltd., IL
GEX
Jul 15, 2020K201109CO2 Laser Therapy System
Shanghai Apolo Medical Technology Co., Ltd., CN
GEX
Jun 30, 2020K201455Litho 150, Cyber Ho 150
Quanta System Spa, IT
GEX
Jun 26, 2020K200736Stardust Med
I.T.S. Group S.R.L., IT
GEX
Jun 24, 2020K193477Nd: YAG Laser Therapy Systems
Beijing Kes Biology Technology Co., Ltd., CN
GEX
Jun 9, 2020K200786Venus Epileve
Venus Concept USA, Inc.
GEX
Jun 9, 2020K200042CO2 Laser System
Beijing Superlaser Technology Co., Ltd., CN
GEX
Jun 4, 2020K200104Oxylight
Raja Trading Company, Inc.
GEX
May 28, 2020K200116PicoSecond Nd: YAG Laser System
Shanghai Apolo Medical Technology Co., Ltd., CN
GEX
May 27, 2020K200525Medical Diode Laser Hair Removal System
Weifang Mingliang Electronics Co., Ltd., CN
GEX
May 26, 2020K201111GentleMax Pro Plus
Candela Corporation
GEX
May 21, 2020K200751Photodynamic Therapy (PDT) Equipment
Shangdong Huamei Technology Co., Ltd., CN
GEX
May 9, 2020K200659Dermalux Tri-Wave MD
Aesthetic Technology, Ltd., GB
GEX
Apr 24, 2020K192856MT One
M&T S.R.L., IT
GEX
Apr 17, 2020K200118Diode Laser Therapy Device
Shanghai Apolo Medical Technology Co., Ltd., CN
GEX
Apr 13, 2020K193464ND:YAG Laser
Beijing Superlaser Technology Co., Ltd., CN
GEX
Apr 6, 2020K191970Diode Laser Hair Removal System
Beijing Sano Laser S&T Development Co.,Ltd, CN
GEX
Apr 3, 2020K192735Diode Laser Hair Removal Machine
Beijing Lead Beauty S & T Co., Ltd., CN
GEX
Mar 27, 2020K193656SkyPulse
Fotona D.O.O., SI
GEX
Mar 26, 2020K192951Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun
Ellipse A/S, DK
GEX
Mar 25, 2020K193661LightWalker Laser System Family
Fotona D.O.O., SI
GEX
Mar 20, 2020K193609Q Switched Nd: YAG Laser machine
Beijing Lead Beauty S & T Co., Ltd., CN
GEX
Mar 17, 2020K192272Wolf445nm
A.R.C Laser GmbH, DE
GEX
Mar 16, 2020K200110SANDRO Dual
Wontech Co., Ltd., KR
GEX
Mar 16, 2020K193486Epic 980
Biolase, Inc.
GEX
Mar 13, 2020K192483MeDioStar
Asclepion Laser Technologies GmbH, DE
GEX
Mar 12, 2020K193367elysion-pro
High Technology Products S.L.U, ES
GEX
Mar 10, 2020K200331Rapid Acoustic Pulse Device
Soliton, Inc.
GEX
Mar 10, 2020K193446Bare: 808
Luvo Medical Technologies, Inc., CA
GEX
Mar 9, 2020K193426Elite iQ
Cynosure, LLC
GEX
Feb 25, 2020K200234Surgical laser fibers
Quanta System Spa, IT
GEX
Feb 21, 2020K192600Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60
Quanta System Spa, IT
GEX
Feb 20, 2020K192617Gemini 810+980 Soft Tissue Laser
Azena Medical, LLC
GEX
Jan 17, 2020K192583PicoLazer Laser System
Rohrer Aesthetics, LLC
GEX
Jan 16, 2020K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser System
Lumenis, Ltd., IL
GEX
Jan 14, 2020K193478XTRAC Momentum Excimer Laser System
Strata Skin Sciences, Inc.
GEX
Jan 3, 2020K193375NeuroBlate System
Monteris Medical,
GEX
Jan 3, 2020K191501PALLAS 308/311 Solid-State UV Laser System
Laseroptek Co., Ltd., KR
GEX
Dec 20, 2019K192990Litho Evo
Quanta System Spa, IT
GEX
Dec 20, 2019K192755Soli-Lite LG4 Galileo
Silhouet-Tone Corporation, CA
GEX
Dec 16, 2019K192539Deka Luxea
El.En Electronic Engineering Spa, IT
GEX
Dec 13, 2019K192569Diode Laser Therapy System
San HE Lefis Electronics Co., Ltd., CN
GEX
Dec 10, 2019K192516Diode Laser 808nm
Beijing Superlaser Technology Co., Ltd., CN
GEX
Dec 5, 2019K191962Vitra 2
Quantel Medical, FR
GEX
Dec 4, 2019K192430Epic 980
Biolase, Inc.
GEX
Dec 3, 2019K192528CO2 Laser Therapy System
Shangdong Huamei Technology Co., Ltd., CN
GEX
Nov 19, 2019K192269TwinScan 808/755 Laser System
Gme German Medical Engineering GmbH, DE
GEX
Nov 12, 2019K192331LaseMD LEO Laser System
Lutronic Global
GEX
Nov 1, 2019K191693BC-5
Reveallux, Corp
GEX

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