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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
Dec 5, 2016K163222Discovery Pico Family
Quanta System Spa, IT
GEX
Dec 1, 2016K163009Litho
Quanta System Spa, IT
GEX
Nov 22, 2016K162191NAVILAS Laser System
Od-Os GmbH, DE
GEX
Nov 18, 2016K162363V30 system, V-Form Handpiece BC Medium applicator
Viora , Ltd., IL
GEX
Nov 16, 2016K162914VenaCure EVLT NeverTouch Procedure Kit
AngioDynamics, Inc.
GEX
Nov 16, 2016K161692Diode Laser Therapy Machine
Beijing Adss Development Co., Ltd., CN
GEX
Nov 9, 2016K162781Magma Spark
Formatk Systems , Ltd., IL
GEX
Nov 2, 2016K161670Lucid Q-PTP / HWA 55
Bison Medical Co, Ltd., KR
GEX
Oct 28, 2016K160488Cutera enlighten III Laser System
Cutera, Inc.
GEX
Oct 28, 2016K160312FRAXIS DUO
Ilooda Co,., Ltd., KR
GEX
Oct 27, 2016K162169EdgeOne CO2 Laser
Jeisys Medical, Inc., KR
GEX
Oct 26, 2016K162762NeuroBlate System
Monteris Medical, Inc.
GEX
Oct 14, 2016K161981Olive Plus
Ama Network, Inc.
GEX
Oct 5, 2016K161925CO2 Laser Therapy Machine
Beijing Adss Development Co., Ltd., CN
GEX
Sep 29, 2016K162416IRIDEX Cyclo G6 Laser System, G-Probe Illuminate
Iridex Corporation
GEX
Sep 26, 2016K161185LUCERNA Dental Laser
Viax Dental Lab, CR
GEX
Sep 21, 2016K160413Sterling 5W Diode Laser
CAO Group, Inc.
GEX
Sep 16, 2016K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultr
Ellipse A/S, DK
GEX
Sep 9, 2016K161356Matrix LS-40 CO2 Laser System
Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd, CN
GEX
Aug 26, 2016K161503ORION
Yerim Engineering Co., Ltd., KR
GEX
Aug 16, 2016K161403A.R.C. Laser Surgical Fibers and Probes
A.R.C Laser GmbH, DE
GEX
Jul 28, 2016K161771Medilas H Laser Fibers
Dornier Medtech America, Inc.
GEX
Jul 28, 2016K161669Waterlase Express
Biolase, Inc.
GEX
Jul 26, 2016K153124DuraLazeTM HoLEP Laser Fiber
Medkey, LLC
GEX
Jul 5, 2016K160607PicoWay Laser System
Syneron Candela Corporation
GEX
Jun 29, 2016K152737Lite Touch
Focus Medical, LLC
GEX
Jun 9, 2016K152667ATOVEN-Reusable Laser Fiber
Diotech CO, KR
GEX
Jun 2, 2016K160012O-pel Laser and families of probe delivery devices
Precise Light Surgical
GEX
Jun 2, 2016K152856Helios III
Laseroptek Co., Ltd., KR
GEX
May 17, 2016K160480PicoSure Workstation
Cynosure, Inc.
GEX
May 5, 2016K160952Alma Diode Tabletop Laser
Alma, Ltd., IL
GEX
Apr 22, 2016K160227ACCENTO / HWA Dual/Single laser
Bison Medical Co, Ltd., KR
GEX
Apr 15, 2016K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral Firing Fiber
Surgical Laser Incorporated
GEX
Apr 12, 2016K153229Superbium
Bios S.R.L., IT
GEX
Apr 6, 2016K153566Magma System
Formatk Systems , Ltd., IL
GEX
Apr 5, 2016K160368EVO platform
Quanta System Spa, IT
GEX
Mar 29, 2016K153564PURE CRYOGEN
Air Liquide Healthcare America Corporation
GEX
Mar 18, 2016K160513Quanta System Surgical Laser fibers
Quanta System Spa, IT
GEX
Mar 15, 2016K151763PerioLase Nd:YAG Pulsed Dental Laser System
Millennium Dental Technologies, Inc.
GEX
Mar 9, 2016K153671Family of CoolGlide Aesthetic Lasers
Cutera, Inc.
GEX
Mar 2, 2016K153527PicoWay Laser System
Syneron Candela Corporation
GEX
Feb 26, 2016K160392Novilase Laser Therapy System, Model LTS-2
Novian Health, Inc.
GEX
Feb 25, 2016K152736SKIN CARE
C.I.S, Ltd., IL
GEX
Feb 19, 2016K152611V20 system
Viora , Ltd., IL
GEX
Feb 12, 2016K153718Spirit Hair Removal laser Family
Active Optical Systems , Ltd., IL
GEX
Feb 12, 2016K151569Tranberg CLS Laser Fiber
Clinical Laserthermia Systems, AB, SE
GEX
Feb 9, 2016K152898DIODE LASER THERAPY SYSTEMS
Beijing Sincoheren Science and Tech. Development Co., Ltd., CN
GEX
Feb 4, 2016K152529NaturaLase CO2 Laser System
Focus Medical, LLC
GEX
Jan 19, 2016K143713Lustre PRO Light System
Ambicare Health, Ltd., GB
GEX
Dec 23, 2015K151890Medical Diode Laser Systems
Wuhan Gigaa Optronics Technology Co., Ltd., CN
GEX

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