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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 16, 2011K112987TWISTER SIDE FIRE OPTICAL FIBER DELIVERY SYSTEM
Biolitec Medical Devices, Inc.
GEX
Dec 7, 2011K110364DORNIER MEDILAS D LITEBEAM+ 1470
Dornier Medtech America, Inc.
GEX
Nov 16, 2011K113212DENTAL LASER THERAPY SYSTEM
China Daheng Group, Inc., CN
GEX
Nov 3, 2011K112299ENDOVASCULAR LASER VEIN SYSTEM KIT
Biolitec Medical Devices, Inc.
GEX
Oct 21, 2011K112166ULTRALASE FLEXIBLE CO2 LASER WAVEGUIDE
W and R Investments Dba Laser Engineering
GEX
Oct 5, 2011K112715CANDELA GENTLEMAX FAMILY OF LASERS
Candela Corp.
GEX
Sep 30, 2011K112442RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM
Biolitec Medical Devices, Inc.
GEX
Sep 28, 2011K111475AURIGA XL
Starmedtec GmbH, DE
GEX
Sep 20, 2011K112253CERALAS 147NM DIODE LASER SYSTEM
Biolitec, Inc.
GEX
Sep 16, 2011K102359PICASSO/ PICASSO LITE/ PICASSO PERIO
Amd Lasers, LLC
GEX
Sep 14, 2011K111360SHEAUMANN PL-980
Sheaumann Lasers
GEX
Sep 13, 2011K112031ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATION
Alma Lasers, Inc.
GEX
Sep 13, 2011K111359SHEAUMANN PL-1064
Sheaumann Lasers
GEX
Sep 6, 2011K112324CERALAS 980NM DIODE LASER FAMILY
Biolitec Medical Devices, Inc.
GEX
Aug 25, 2011K111592YOULASER CO2 LASER SYSTEM
Quanta System Spa, IT
GEX
Jul 25, 2011K111213VISION ONE LASER SYSTEM
Lumenis, Inc.
GEX
Jul 18, 2011K111144CANDELA GENTLELASE FAMILY OF LASERS
Candela Corp.
GEX
Jul 8, 2011K111851MEDIOSTAR NEXT
Asclepion Laser Technologies GmbH, DE
GEX
Jul 1, 2011K110897CORTEX CO2 / ER:YAG LASER SYSTEM
Sandstone Medical Technologies, LLC
GEX
Jul 1, 2011K101306SP DYNAMIS, SP SPECTRO, XS DYNAMIS, XS SPECTRO, XP DYNAMIS, XP SPECTRO, MODELS M021-4AF/3, M002-2A
Fotona D.D., SI
GEX
Jun 28, 2011K110243MEDART DIODE LASER SYSTEM & ACCESSORIES
Medart A/S, GB
GEX
Jun 22, 2011K110907PALOMAR ICON (TM) AESTHETIC SYSTEM
Palomar Medical Technologies, Inc.
GEX
Jun 22, 2011K102954CUTERA QSWITCH LASER SYSTEM
Cutera, Inc.
GEX
May 13, 2011K110225ANGIODYNAMICS, INC. VENACURE 1470 LASER
AngioDynamics, Inc.
GEX
Apr 28, 2011K103455SPECTRA LASER SYSTEM
Lutronic Corporation
GEX
Apr 27, 2011K110502TRIPLEX ER. YAG / ND: YAG SYSTEM
Sandstone Medical Technologies, LLC
GEX
Apr 19, 2011K110434TRIXEL CO2 LASER
BEIJING SYNTECH LASER CO., LTD., CN
GEX
Apr 8, 2011K110304APEX ER. YAG / IPL SYSTEM
Sandstone Medical Technologies, LLC
GEX
Apr 6, 2011K103654VELA XL
Starmedtec GmbH, DE
GEX
Mar 29, 2011K110685FLEXIVA TRACTIP
Boston Scientific Corp
GEX
Mar 28, 2011K110686ACCUTRAC
Boston Scientific Corp
GEX
Mar 18, 2011K101916JOULE MULTI-PLATFORM SYSTEM
Sciton, Inc
GEX
Feb 24, 2011K110080RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM
Biolitec, Inc.
GEX
Feb 15, 2011K103753SIROLASER ADVANCE, SIROLASER XTEND, SIROLASER XTEND UPGRADED, FONALASER
Sirona Dental Systems GmbH, DE
GEX
Feb 10, 2011K110079SPPHINE PLUS STM 3W DIODE LASER
Den-Mat Holdings, LLC
GEX
Jan 31, 2011K103288DEKA SYNCHRO FT
El.En Electronic Engineering Spa, IT
GEX
Jan 20, 2011K103539QUANTA SYSTEM DUOLITE
Quanta System Spa, IT
GEX
Jan 14, 2011K103501ALMA LASERS PIXEL CO2 LASER SYSTEM, DELIVERY DEVICE AND ACCESSORIES
Alma Lasers, Inc.
GEX
Jan 12, 2011K101904SMARTXIDE 50 HS/MS
El.En Electronic Engineering Spa, IT
GEX
Dec 29, 2010K103667SAPPHIRE ST PORTABLE DIODE LASER
Den-Mat Holdings, LLC
GEX
Dec 16, 2010K102755CERALAS E/ 1470NM FIBER-COUPLED DIODE LASER FAMILY; CREALAS HPD MULTIWAVELENGHT 980NM/ 1470NM FIBER-COUPLED DIODE LASER
Biolitec, Inc.
GEX
Dec 15, 2010K102796ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT
AngioDynamics, Inc.
GEX
Dec 10, 2010K102749QUANTA CYBER TM 150W
Quanta System Spa, IT
GEX
Dec 1, 2010K102639SL3
Discus Dental, LLC
GEX
Nov 26, 2010K100199ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND VENACUREEVLT PROCEDURE KIT
AngioDynamics, Inc.
GEX
Nov 22, 2010K101817LIGHTWALKER AT, MODEL M021-5AF/1, LIGHTWALKER DT, MODEL M021-5AF/2, LIGHTWALKER ST-E, MODEL M002-6A/2, LIGHTWALKER ST-N
Fotona D.D., SI
GEX
Nov 19, 2010K103118REVLITE Q-SWITCHED ND: YAG LASER SYSTEM WITH NADPIECE ADAPTOR
Hoya Photonics, Inc.
GEX
Nov 17, 2010K102669DIODE LASER THERAPY SYSTEM
China Daheng Group, Inc., CN
GEX
Nov 9, 2010K101321EMATRIX CO2
Syneron Medical, Ltd., IL
GEX
Oct 27, 2010K101712ENDOVASCULAR LAER VEIN SYSTEM KIT
Biolitec, Inc.
GEX

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