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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 23, 2018K180518GME LinScan Lite 808 Laser System
Gme German Medical Engineering GmbH, DE
GEX
Jul 16, 2018K181019Diode Laser System
Guangzhou Huafei Tongda Technology Co., Ltd., CN
GEX
Jul 11, 2018K181523Syneron CO2RE System
Syneron-Candela Corp
GEX
Jul 11, 2018K180967Dental Diode Laser System
Lazon Medical Laser Co., Ltd., CN
GEX
Jul 5, 2018K181044400um Perforator and Accessory Vein Ablation Kit
AngioDynamics, Inc.
GEX
Jul 5, 2018K173359Fractional CO2 Surgical Laser System
Ami, Inc., KR
GEX
Jun 28, 2018K180993Beacon Advanced CO2 Laser System
Omniguide, Inc.
GEX
Jun 19, 2018K173700PICOPLUS Laser System
Lutronic Corporation, KR
GEX
Jun 14, 2018K180719InMode Diolaze System
Inmode MD , Ltd., IL
GEX
Jun 5, 2018K180593Vbeam Prima Laser System
Syneron-Candela
GEX
May 18, 2018K180508JOULE SYSTEM
Sciton, Inc
GEX
May 8, 2018K180922Empower H100, Cyber Ho 100, Litho 100
Quanta System Spa, IT
GEX
Apr 20, 2018K180140ProFlex Laser Fibers
Innovaquartz, LLC
GEX
Apr 20, 2018K171443Etherea MX
Vydence Medical Industria E Comercio Ltda, BR
GEX
Apr 17, 2018K180353Diode laser hair removal device
Zhengzhou PZ Laser Slim Technology Co., Ltd., CN
GEX
Apr 3, 2018K180597AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO
Lumenis, Ltd., IL
GEX
Mar 16, 2018K180426Empower H35
Quanta System Spa, IT
GEX
Mar 15, 2018K180423Empower H65
Quanta System Spa, IT
GEX
Mar 15, 2018K180406Ellipse Ydun
Ellipse A/S, DK
GEX
Mar 15, 2018K180224ELEMENT-TL
Elemenic Co., Ltd., KR
GEX
Mar 8, 2018K180044SIROLaser Blue
Dentsply Sirona
GEX
Mar 7, 2018K180350Dornier Medilas H Solvo 35 Laser
Dornier Medtech America
GEX
Mar 7, 2018K172818LMT-3000
Lameditech Co. , Ltd., KR
GEX
Feb 23, 2018K173677InMode VLaze
Inmode MD , Ltd., IL
GEX
Feb 22, 2018K173067LightForce LTS Model 1000, 1500, 2500, and 4000
Litecure, LLC
GEX
Feb 21, 2018K180193DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto)
El.En Electronic Engineering Spa, IT
GEX
Feb 14, 2018K180158Surgical Laser fibers
Quanta System Spa, IT
GEX
Feb 14, 2018K172439Siberian Fit
Vydence, BR
GEX
Feb 7, 2018K173199PicoSure Workstation
Cynosure, Inc.
GEX
Jan 29, 2018K173285JOULE SYSTEM
Sciton, Inc
GEX
Jan 9, 2018K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, Soprano
Alma Lasers, Inc.
GEX
Dec 13, 2017K1730022940 nm Er:Yag Laser Handpiece
Quanta System Spa, IT
GEX
Dec 7, 2017K172908Q-Switched Nd:YAG Laser System
Ami, Inc., KR
GEX
Dec 1, 2017K173038CuRAS Nd:YAG Laser
Ilooda Co,., Ltd., KR
GEX
Dec 1, 2017K172819LightWalker Laser System Family
Fotona D.O.O., SI
GEX
Nov 29, 2017K172771Epic Pro 940
Biolase, Inc.
GEX
Nov 20, 2017K173169Rapid Family
Sharplight Technologies, Ltd., IL
GEX
Nov 17, 2017K173305NeuroBlate System
Monteris Medical,
GEX
Nov 17, 2017K172363DEKA SMARTXIDE ULTRASPEED
El.En Electronic Engineering Spa, IT
GEX
Nov 17, 2017K172362DEKA SMARTXIDE TOUCH
El.En Electronic Engineering Spa, IT
GEX
Nov 3, 2017K172639PALLAS 308/311 Solid-State UV Laser System
Laseroptek Co., Ltd., KR
GEX
Oct 27, 2017K172077Cutera enlighten III Laser System
Cutera, Inc.
GEX
Oct 26, 2017K172325Rhapsody H-30 Holmium Laser System
Cook Incorporated
GEX
Oct 20, 2017K172881NeuroBlate System
Monteris Medical,
GEX
Oct 19, 2017K172376Discovery Pico, Discovery Pico Plus
Quanta System Spa, IT
GEX
Oct 17, 2017K172198585
Quanta System Spa, IT
GEX
Oct 6, 2017K172413MT ONE
M&T S.R.L., IT
GEX
Sep 22, 2017K171986Sterling Supreme Diode Laser
CAO Group, Inc.
GEX
Sep 18, 2017K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity
Lumenis, Ltd., IL
GEX
Sep 12, 2017K170409PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System
Topcon Medical Laser Systems, Inc. (Tmls)
GEX

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