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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 17, 2019K191942MT One Diamond
M&T S.R.L., IT
GEX
Oct 10, 2019K190319Waterlase Laser System Family
Biolase, Inc.
GEX
Sep 17, 2019K191842Discovery Pico, Discovery Pico Plus, Discovery Pico Derm
Quanta System Spa, IT
GEX
Sep 16, 2019K191685PicoWay Laser System
Candela Corporation
GEX
Sep 12, 2019K191518CO2 Laser System
Shenzhen Gsd Tech Co., Ltd., CN
GEX
Sep 10, 2019K181614Sterling Supreme Diode Laser
CAO Group, Inc.
GEX
Sep 10, 2019K181602Pioneer Elite Diode Laser
CAO Group, Inc.
GEX
Sep 9, 2019K181601Precise SHP Diode Laser
CAO Group, Inc.
GEX
Sep 6, 2019K192160EVO Platform
Quanta System Spa, IT
GEX
Sep 5, 2019K183563Holinwon 30
Wontech Co., Ltd., KR
GEX
Aug 30, 2019K191554LightWalker Laser System Family
Fotona D.O.O., SI
GEX
Aug 25, 2019K183122810nm Diode Laser System
Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd, CN
GEX
Aug 16, 2019K191349980nm Diode Laser Therapy Device
Shanghai Apolo Medical Technology Co., Ltd., CN
GEX
Aug 9, 2019K183647SOLTIVE™ Laser System(SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Acce
Olympus Surgical Technologies America
GEX
Aug 2, 2019K191321Primelase Excellence
High Technology Products S.L.U, ES
GEX
Jul 31, 2019K191611Diode Laser Therapy Systems
Wingderm Electro-Optics , Ltd., CN
GEX
Jul 12, 2019K182930PerioLase Nd:YAG Pulsed Dental Laser System
Millennium Dental Technologies, Inc.
GEX
Jul 9, 2019K191162EpiLaze Multi-wavelength Laser
Rohrer Aesthetics, LLC
GEX
Jun 26, 2019K190938Phototherapy System
Shanghai Apolo Medical Technology Co., Ltd., CN
GEX
Jun 17, 2019K190936Q-Switched Nd: YAG Laser System
Shanghai Apolo Medical Technology Co., Ltd., CN
GEX
Jun 14, 2019K183566CLARITY II Laser System
Lutronic Corporation, KR
GEX
May 24, 2019K190542Soliton Acoustic Wave Device
Soliton, Inc.
GEX
May 2, 2019K183199TRIO Handpiece
Omniguide, Inc.
GEX
Apr 24, 2019K183156V-Laser
Wontech Co., Ltd., KR
GEX
Apr 15, 2019K182924Diode Laser Treatment System
Weifang KM Electronics Co., Ltd., CN
GEX
Mar 26, 2019K190392WaveLight FS200 Patient Interface
Alcon Laboratories, Inc.
GEX
Mar 6, 2019K182173Joule System
Sciton, Inc
GEX
Mar 1, 2019K190007Vydence Laser Family
Vydence Medical Industria E Comercio Ltda, BR
GEX
Feb 1, 2019K183452Vbeam Prima Laser System
Candela Corp.
GEX
Jan 4, 2019K183392PicoLO Nd:YAG Picosecond Laser System
Laseroptek Co., Ltd., KR
GEX
Dec 27, 2018K182045Lotus III Multi-Pulsed Er: Yag Laser System
Laseroptek Co., Ltd., KR
GEX
Dec 12, 2018K182997enlighten III Laser System
Cutera, Inc.
GEX
Dec 11, 2018K183307Magma Spark Pro (Magma Spark Plus, Alpha)
Formatk Systems , Ltd., IL
GEX
Dec 10, 2018K182831SabreLine and SabreGuard Laser Fibers
Coloplast Corp.
GEX
Nov 30, 2018K182663Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System
Finemec Co., Ltd., KR
GEX
Nov 14, 2018K182604New Era
Step UP Skin Laser, LLC
GEX
Nov 2, 2018K182270Cellene CO2 Laser System
Bio-Med USA, Inc.
GEX
Oct 31, 2018K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro
Fotona D.O.O., SI
GEX
Oct 17, 2018K182669Youlaser CO2
Quanta System Spa, IT
GEX
Oct 15, 2018K182036NeuroBlate System
Monteris Medical,
GEX
Oct 2, 2018K181867Deka Smartxide2 Trio
El.En Electronic Engineering Spa, IT
GEX
Sep 17, 2018K181632Venacure 1470 Pro
Quanta System Spa, IT
GEX
Sep 14, 2018K173827LightScalpel
Lightscalpel, LLC
GEX
Sep 14, 2018K173676A-FIT
Hironic Co., Ltd., KR
GEX
Sep 5, 2018K181662Iridex TruFocus LIO Premiere
Iridex Corporation
GEX
Sep 4, 2018K181510ECHOLASER X4
El.En Electronic Engineering Spa, IT
GEX
Aug 30, 2018K181486DEKA Motus AY
El.En Electronic Engineering Spa, IT
GEX
Aug 1, 2018K181480MMD Tip
Strata Skin Sciences, Inc.
GEX
Jul 31, 2018K181272Picocare Family
Wontech Co., Ltd., KR
GEX
Jul 30, 2018K181431Laser Ureteral Catheter
Cook Incorporated
GEX

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