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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
Jan 16, 2013K121570AURIGA QI
Starmedtec GmbH, DE
GEX
Jan 15, 2013K123004MIRA LASERS
Mira Lasers, LLC, CN
GEX
Jan 10, 2013K122922E-BEAM ND: YAG LASER
Eclipse Aesthetics, LLC
GEX
Dec 20, 2012K123168Q-PLUS T+ IPL LASER SYSTEM
Quanta System Spa, IT
GEX
Dec 14, 2012K123385MEDILAS H LASER FIBERS
Dornier Medtech America, Inc.
GEX
Dec 14, 2012K123257EMVERA DIOLUX
Emvera Technologies, Inc.
GEX
Dec 14, 2012K113018APOLLO V+ MEDICAL PLATFORM, APOLLO IV+ MEDICAL PLATFORM, NICE STATION LIGHT BASED PLATFORM
BEIJING SYNTECH LASER CO., LTD., CN
GEX
Dec 7, 2012K120932OPELASER PRO II AND THE OPELASER LITE II
The Yoshida Dental Mfg. Co., Ltd.
GEX
Dec 3, 2012K123031BWF-5 MEDICAL LASER SERIES
Litecure, LLC
GEX
Nov 29, 2012K123037LIGHTSCALPEL
Lightscalpel, LLC
GEX
Nov 28, 2012K121475TXCELL SCANNING LASER DELIVERY SYSTEM
Iridex Corp
GEX
Nov 27, 2012K121346PICOSURE WORKSTATION
Cynosure, Inc.
GEX
Oct 1, 2012K120460SMARTLUX
Medmix Co., Ltd.
GEX
Sep 28, 2012K121286EPIC 10
Biolase Technology, Inc.
GEX
Sep 25, 2012K121580SURELASE CO2 LASER SYSTEM
Clinicon Corp.
GEX
Sep 17, 2012K120235MODEL FAMILY OF AEROLASE ND:YAG LASERS: FRIENDLYLIGHT ND: YAG LASERS, FRIENDLYLIGHT NEO, LIGHTPOD ND: YAG LASERS, LIGHTP
Aerolase Medical Lasers, LLC
GEX
Sep 13, 2012K120737TRIA LASER HAIR REMOVAL SYSTEM
Tria Beauty, Inc.
GEX
Aug 30, 2012K113472PRECISE SHP DIODE LASER
CAO Group, Inc.
GEX
Aug 1, 2012K121938MEDILAS H RFID LASER FIBER
Dornier Medtech America, Inc.
GEX
Jul 27, 2012K120926ENDOBEAM HOLMIUM LASER FIBERS
C.R. Bard, Inc.
GEX
Jul 27, 2012K113489ORION
Asclepion Laser Technologies GmbH, DE
GEX
Jul 25, 2012K120377ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-A
J. Morita USA, Inc.
GEX
Jul 18, 2012K121162POLARIS Q-SWITCH RUBY SYSTEM
Sandstone Medical Technologies, LLC
GEX
Jul 10, 2012K121471LIGHTSCALPEL FAMILY OF HANDPIECE TIPS FOR CO2 SURGICAL LASERS
Lightscalpel, LLC
GEX
Jun 28, 2012K120810FIBEROPTIC LASER DELIVERY SYSTEM
Fiberoptic Fabrications, Inc.
GEX
Jun 21, 2012K121031WAVELIGHT FS200 PATIENT INTERFACE 1505
Alcon Research, Ltd.
GEX
Jun 15, 2012K120870GREENLIGHT MOXY FIBER OPTIC
American Medical Systems
GEX
Jun 13, 2012K120573MEDART 620
Medart A/S, GB
GEX
Jun 11, 2012K113868EPLUS SKIN TREATMENT SYSTEM
Syneron, Ltd., IL
GEX
May 23, 2012K120622PALOMAR VECTUS LASER
Palomar Medical Technologies, Inc.
GEX
May 13, 2012K121127SIDELAZE LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440NM WAVELENGTH LASERS
Cynosure, Inc.
GEX
May 11, 2012K112669TATTOOSTAR EFFECT Y
Asclepion Laser Technologies GmbH, DE
GEX
Apr 26, 2012K120437TWISTER SIDE-FIRE FIBER OPTIC DELIVERY SYSTEM
Biolitec Sia (Latvia)
GEX
Apr 24, 2012K120231EVOLVE HPD 980/ 1470NM MULTIWAVELENGTH DIODE LASER (EVOLVE DUAL)
Biolitec Medical Devices, Inc.
GEX
Apr 13, 2012K112141SMARTEPIL,DEPILASE YAG LASE PLUS
Castle Laser Systems, Limited
GEX
Apr 6, 2012K112505ETHEREA
Regulatory Insight, Inc.
GEX
Apr 5, 2012K113502ADVANTAGE LASER SYSTEM
Lutronic Corporation
GEX
Apr 3, 2012K113115EPICARE YAG
Light Age, Inc.
GEX
Mar 13, 2012K113688MEGABEAM REUSABLE FIBER OPTIC DELIVERY SYSTEM
Biolitec Medical Devices, Inc.
GEX
Mar 8, 2012K113151IFS LASER SYSTEM
Abbott Medical Optics, Inc.
GEX
Feb 22, 2012K113588SPECTRA LASER SYSTEM
Lutronic Corporation
GEX
Feb 16, 2012K111689STLASE
Dental Photonics, Inc.
GEX
Feb 14, 2012K113390LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500)
Meridian AG
GEX
Jan 30, 2012K112600ANGIODYNAMICS, INC. VENACURE NEVERTOUCH DIRECT PROCEDURE KIT
AngioDynamics, Inc.
GEX
Jan 24, 2012K113858MEGABEAM ENDO-ENT PROBE
Biolitec Medical Devices, Inc.
GEX
Jan 20, 2012K113709MEGABEAM FIBER OPTIC DELIVERY SYSTEM WITH ADDITIONAL TIPS & HANDPIECE
Biolitec Medical Devices, Inc.
GEX
Jan 19, 2012K113792MEGABEAM ENDOCULAR PROBE AND ASPIRATING ENDOCULAR PROBE
Biolitec Medical Devices, Inc.
GEX
Jan 13, 2012K112013EVOLVE(R) HPD 980/1470NM MULTIWAVELENGTH DIODE LASER
Biolitec, Inc.
GEX
Dec 22, 2011K113140VARI-LASE WIREFIBER LASER FIBER
Vascular Solutions, Inc.
GEX
Dec 21, 2011K111303DERMATOLOGICAL TREATMENT DEVICE FAMILY
Sharplight Technologies, Ltd., IL
GEX

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