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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 21, 2010K101006WAVELIGHT FS200 LASER SYSTEM MODEL: FS200
Alcon Research, Ltd.
GEX
Oct 15, 2010K093545PINPOINTE FOOTLASER MODEL 6W, 30W, 100W
Incisive, Inc. (Formerly Named Incisive, LLC)
GEX
Sep 28, 2010K102716MODIFIED ALMA LASERS FAMILY OF SOPRANO XL MULTI-APPLICATION PLATMFORMS
Alma Lasers, Inc.
GEX
Sep 28, 2010K102036DOCTOR SURGERY DIODE LASERS FAMILY
Lambda S.P.A., IT
GEX
Sep 23, 2010K101601AFFIRM DO DIODE LASER
Cynosure, Inc.
GEX
Sep 23, 2010K101573ACCUSCULPT II LASER SYSTEM
Lutronic Corporation
GEX
Sep 20, 2010K092734E-LIGHT LINE
Espansione Marketing S.P.A, IT
GEX
Sep 17, 2010K101555CO2 LASER SYSTEM
Advanced Technology Laser Co., Ltd., CN
GEX
Sep 15, 2010K100726CERALAS D/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS HPD/ 980NM
Biolitec, Inc.
GEX
Sep 13, 2010K101783COOLTOUCH MODEL CT3PZ, COOLTOUCH CT3 PLUS COOLBREEZE
New Star Lasers, Inc.
GEX
Sep 10, 2010K094049STLASE DIODE LASER
Dental Photonics, Inc.
GEX
Aug 18, 2010K101152NATURALASE DIODE LASER FAMILY NATURALASE MODEL NL980, NATURALASE DIODE LASER FAMILY NATURALASE NL810
Focus Medical, LLC
GEX
Aug 13, 2010K100143PILOT DIODE LASER, MODEL 002-00139
CAO Group, Inc.
GEX
Aug 13, 2010K100098PLASMALIPO/PLASMA D30 LSER SURGICAL DEVICE
Jm System Co., Ltd.
GEX
Aug 11, 2010K101658WATERLASE MD TURBO PLUS MODEL 7200XXX
Biolase Technology, Inc.
GEX
Jul 29, 2010K102050Q-SWITCHED ND:YAG LASER SYSTEM, MODEL GLOBALCURE-SC6
Advanced Technology Laser Co., Ltd., CN
GEX
Jul 22, 2010K100558QUANTA DIODE LASER SYSTEM
Quanta System Spa, IT
GEX
Jul 21, 2010K100678SUPRA SCAN DELIVERY SYSTEM
Quantel Medical, FR
GEX
Jul 16, 2010K092860LASEMAR 800, 1000, 1500
Eufoton S.R.L., IT
GEX
Jul 8, 2010K101415THERACLEAR
Theravant Corporation
GEX
Jun 16, 2010K100893CHEVEUX DIODE LASER SYSTEM
Sandstone Medical Technologies, LLC
GEX
Jun 11, 2010K100746FIBER ONE
American Medical Systems
GEX
May 20, 2010K100194OPTICAL INTEGRITY LASERGUARD FIBERS
Optical Integrity, Inc.
GEX
May 12, 2010K093087BWF-5 MEDICAL LASER SERIES
Litecure, LLC
GEX
Apr 21, 2010K100415ACUPULSE 30/40 ST CO2 LASER SYSTEM AND ACUPULSE 40WG CO2 LASER SYSTEM
Lumenis, IL
GEX
Apr 12, 2010K100384FIBERLASE C02 LASER WAVEGUIDE
Lumenis, Ltd., IL
GEX
Mar 29, 2010K100270ARTISAN AESTHETIC SYSTEM
Palomar Medical Technologies, Inc.
GEX
Mar 23, 2010K093048D-STORM 810NM, D-STORM 980NM
Light Instruments, IL
GEX
Mar 17, 2010K100035MODEL VISULAS 532S LASER WITH THE VITE OPTION
Carl Zeiss Meditec, AG
GEX
Mar 16, 2010K100474QUICKLASEDUAL+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 MODEL: 3W,5W,3W,5W
Quicklase Limited
GEX
Mar 12, 2010K093852EZLASE 3 LASER SYSTEM
Biolase Technology, Inc.
GEX
Feb 24, 2010K100228VERSAPULSE MODEL P20 LASER SYSTEM
Lumenis, Inc.
GEX
Feb 18, 2010K093793LS-40 CO2 LASER SYSTEM MODEL LS-40
Sandstone Medical Technologies, LLC
GEX
Feb 12, 2010K100078MODIFIED STRAIGHT FIRE LASER FIBER
Boston Scientific Corp
GEX
Feb 3, 2010K082230VECTRA PLUS LASER SYSTEM AND ACCESSORIES
Xintec Corporation
GEX
Jan 22, 2010K093162FIDELIS PLUS III D, AT FIDELIS D, POWERLASE AT D / FIDELIS PLUS III, AT FIDELIS, POWERLASE AT / FIDELIS ER III D, HT FID
Fotona D.D., SI
GEX
Jan 7, 2010K093502VARI-LASE ENDOVENOUS LASER CONSOLE
Vascular Solutions, Inc.
GEX
Jan 5, 2010K090312TRIA ACNE TREATMENT SYSTEM, MODEL ATS-1 OTC
Tria Beauty, Inc.
GEX
Jan 4, 2010K082586LIGHTWAVE PROFESSIONAL DELUXE
Lightwave Technologies, LLC
GEX
Dec 23, 2009K090820TRIA HAIR REMOVAL LASER SYSTEM
Spectragenics, Inc.
GEX
Dec 11, 2009K093691ACCUMAX
Boston Scientific Corp
GEX
Dec 11, 2009K092964COOLTOUCH VARIA ND:YAG LASER SYSTEM
New Star Lasers, Inc.
GEX
Dec 7, 2009K091746WATERLASE MD, MODEL 7100102
Biolase Technology, Inc.
GEX
Dec 3, 2009K092660SIROLASER ADVANCE
Sirona Dental Systems GmbH, DE
GEX
Nov 24, 2009K083123MEDART MODEL 610 CO2 LASER SYSTEM & ACCESSORIES
Medart A/S, DK
GEX
Nov 20, 2009K093451OMNIGUIDE BEAMPATH CO2 MARK III WAVEGUIDE FIBER WITH LOW PROFILE/LOW LOSS TIP
Omniguide, Inc.
GEX
Nov 20, 2009K090195PALOMAR LUX1540 HANDPIECE
Palomar Medical Technologies, Inc.
GEX
Nov 9, 2009K092735GREENLIGHT XPS LASER SYSTEM
American Medical Systems, Inc.
GEX
Nov 3, 2009K091625EPICARE-DUO LASER SYSTEM
Light Age, Inc.
GEX
Oct 30, 2009K091115ECO2 LASER SYSTEM
Lutronic Corporation
GEX

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