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GEX

2,872 FDA 510(k) clearances · Product code

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RecordFirmDateBuilder
ORION (K113489)Asclepion Laser Technologies GmbH2012-07-27+ Add
ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-A (K120377)J. Morita USA, Inc.2012-07-25+ Add
POLARIS Q-SWITCH RUBY SYSTEM (K121162)Sandstone Medical Technologies, LLC2012-07-18+ Add
LIGHTSCALPEL FAMILY OF HANDPIECE TIPS FOR CO2 SURGICAL LASERS (K121471)Lightscalpel, LLC2012-07-10+ Add
FIBEROPTIC LASER DELIVERY SYSTEM (K120810)Fiberoptic Fabrications, Inc.2012-06-28+ Add
WAVELIGHT FS200 PATIENT INTERFACE 1505 (K121031)Alcon Research, Ltd.2012-06-21+ Add
GREENLIGHT MOXY FIBER OPTIC (K120870)American Medical Systems2012-06-15+ Add
MEDART 620 (K120573)Medart A/S2012-06-13+ Add
EPLUS SKIN TREATMENT SYSTEM (K113868)Syneron, Ltd.2012-06-11+ Add
PALOMAR VECTUS LASER (K120622)Palomar Medical Technologies, Inc.2012-05-23+ Add
SIDELAZE LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440NM WAVELENGTH LASERS (K121127)Cynosure, Inc.2012-05-13+ Add
TATTOOSTAR EFFECT Y (K112669)Asclepion Laser Technologies GmbH2012-05-11+ Add
TWISTER SIDE-FIRE FIBER OPTIC DELIVERY SYSTEM (K120437)Biolitec Sia (Latvia)2012-04-26+ Add
EVOLVE HPD 980/ 1470NM MULTIWAVELENGTH DIODE LASER (EVOLVE DUAL) (K120231)Biolitec Medical Devices, Inc.2012-04-24+ Add
SMARTEPIL,DEPILASE YAG LASE PLUS (K112141)Castle Laser Systems, Limited2012-04-13+ Add
ETHEREA (K112505)Regulatory Insight, Inc.2012-04-06+ Add
ADVANTAGE LASER SYSTEM (K113502)Lutronic Corporation2012-04-05+ Add
EPICARE YAG (K113115)Light Age, Inc.2012-04-03+ Add
MEGABEAM REUSABLE FIBER OPTIC DELIVERY SYSTEM (K113688)Biolitec Medical Devices, Inc.2012-03-13+ Add
IFS LASER SYSTEM (K113151)Abbott Medical Optics, Inc.2012-03-08+ Add
SPECTRA LASER SYSTEM (K113588)Lutronic Corporation2012-02-22+ Add
STLASE (K111689)Dental Photonics, Inc.2012-02-16+ Add
LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500) (K113390)Meridian AG2012-02-14+ Add
ANGIODYNAMICS, INC. VENACURE NEVERTOUCH DIRECT PROCEDURE KIT (K112600)AngioDynamics, Inc.2012-01-30+ Add
MEGABEAM ENDO-ENT PROBE (K113858)Biolitec Medical Devices, Inc.2012-01-24+ Add
MEGABEAM FIBER OPTIC DELIVERY SYSTEM WITH ADDITIONAL TIPS & HANDPIECE (K113709)Biolitec Medical Devices, Inc.2012-01-20+ Add
MEGABEAM ENDOCULAR PROBE AND ASPIRATING ENDOCULAR PROBE (K113792)Biolitec Medical Devices, Inc.2012-01-19+ Add
EVOLVE(R) HPD 980/1470NM MULTIWAVELENGTH DIODE LASER (K112013)Biolitec, Inc.2012-01-13+ Add
VARI-LASE WIREFIBER LASER FIBER (K113140)Vascular Solutions, Inc.2011-12-22+ Add
DERMATOLOGICAL TREATMENT DEVICE FAMILY (K111303)Sharplight Technologies, Ltd.2011-12-21+ Add
TWISTER SIDE FIRE OPTICAL FIBER DELIVERY SYSTEM (K112987)Biolitec Medical Devices, Inc.2011-12-16+ Add
DORNIER MEDILAS D LITEBEAM+ 1470 (K110364)Dornier Medtech America, Inc.2011-12-07+ Add
DENTAL LASER THERAPY SYSTEM (K113212)China Daheng Group, Inc.2011-11-16+ Add
ENDOVASCULAR LASER VEIN SYSTEM KIT (K112299)Biolitec Medical Devices, Inc.2011-11-03+ Add
ULTRALASE FLEXIBLE CO2 LASER WAVEGUIDE (K112166)W and R Investments Dba Laser Engineering2011-10-21+ Add
CANDELA GENTLEMAX FAMILY OF LASERS (K112715)Candela Corp.2011-10-05+ Add
RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM (K112442)Biolitec Medical Devices, Inc.2011-09-30+ Add
AURIGA XL (K111475)Starmedtec GmbH2011-09-28+ Add
CERALAS 147NM DIODE LASER SYSTEM (K112253)Biolitec, Inc.2011-09-20+ Add
PICASSO/ PICASSO LITE/ PICASSO PERIO (K102359)Amd Lasers, LLC2011-09-16+ Add
SHEAUMANN PL-980 (K111360)Sheaumann Lasers2011-09-14+ Add
ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATION (K112031)Alma Lasers, Inc.2011-09-13+ Add
SHEAUMANN PL-1064 (K111359)Sheaumann Lasers2011-09-13+ Add
CERALAS 980NM DIODE LASER FAMILY (K112324)Biolitec Medical Devices, Inc.2011-09-06+ Add
YOULASER CO2 LASER SYSTEM (K111592)Quanta System Spa2011-08-25+ Add
VISION ONE LASER SYSTEM (K111213)Lumenis, Inc.2011-07-25+ Add
CANDELA GENTLELASE FAMILY OF LASERS (K111144)Candela Corp.2011-07-18+ Add
MEDIOSTAR NEXT (K111851)Asclepion Laser Technologies GmbH2011-07-08+ Add
SP DYNAMIS, SP SPECTRO, XS DYNAMIS, XS SPECTRO, XP DYNAMIS, XP SPECTRO, MODELS M021-4AF/3, M002-2A (K101306)Fotona D.D.2011-07-01+ Add
CORTEX CO2 / ER:YAG LASER SYSTEM (K110897)Sandstone Medical Technologies, LLC2011-07-01+ Add
MEDART DIODE LASER SYSTEM & ACCESSORIES (K110243)Medart A/S2011-06-28+ Add
PALOMAR ICON (TM) AESTHETIC SYSTEM (K110907)Palomar Medical Technologies, Inc.2011-06-22+ Add
CUTERA QSWITCH LASER SYSTEM (K102954)Cutera, Inc.2011-06-22+ Add
ANGIODYNAMICS, INC. VENACURE 1470 LASER (K110225)AngioDynamics, Inc.2011-05-13+ Add
SPECTRA LASER SYSTEM (K103455)Lutronic Corporation2011-04-28+ Add
TRIPLEX ER. YAG / ND: YAG SYSTEM (K110502)Sandstone Medical Technologies, LLC2011-04-27+ Add
TRIXEL CO2 LASER (K110434)BEIJING SYNTECH LASER CO., LTD.2011-04-19+ Add
APEX ER. YAG / IPL SYSTEM (K110304)Sandstone Medical Technologies, LLC2011-04-08+ Add
VELA XL (K103654)Starmedtec GmbH2011-04-06+ Add
FLEXIVA TRACTIP (K110685)Boston Scientific Corp2011-03-29+ Add
ACCUTRAC (K110686)Boston Scientific Corp2011-03-28+ Add
JOULE MULTI-PLATFORM SYSTEM (K101916)Sciton, Inc2011-03-18+ Add
RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM (K110080)Biolitec, Inc.2011-02-24+ Add
SIROLASER ADVANCE, SIROLASER XTEND, SIROLASER XTEND UPGRADED, FONALASER (K103753)Sirona Dental Systems GmbH2011-02-15+ Add
SPPHINE PLUS STM 3W DIODE LASER (K110079)Den-Mat Holdings, LLC2011-02-10+ Add
DEKA SYNCHRO FT (K103288)El.En Electronic Engineering Spa2011-01-31+ Add
QUANTA SYSTEM DUOLITE (K103539)Quanta System Spa2011-01-20+ Add
ALMA LASERS PIXEL CO2 LASER SYSTEM, DELIVERY DEVICE AND ACCESSORIES (K103501)Alma Lasers, Inc.2011-01-14+ Add
SMARTXIDE 50 HS/MS (K101904)El.En Electronic Engineering Spa2011-01-12+ Add
SAPPHIRE ST PORTABLE DIODE LASER (K103667)Den-Mat Holdings, LLC2010-12-29+ Add
CERALAS E/ 1470NM FIBER-COUPLED DIODE LASER FAMILY; CREALAS HPD MULTIWAVELENGHT 980NM/ 1470NM FIBER-COUPLED DIODE LASER (K102755)Biolitec, Inc.2010-12-16+ Add
ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT (K102796)AngioDynamics, Inc.2010-12-15+ Add
QUANTA CYBER TM 150W (K102749)Quanta System Spa2010-12-10+ Add
SL3 (K102639)Discus Dental, LLC2010-12-01+ Add
ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND VENACUREEVLT PROCEDURE KIT (K100199)AngioDynamics, Inc.2010-11-26+ Add
LIGHTWALKER AT, MODEL M021-5AF/1, LIGHTWALKER DT, MODEL M021-5AF/2, LIGHTWALKER ST-E, MODEL M002-6A/2, LIGHTWALKER ST-N (K101817)Fotona D.D.2010-11-22+ Add
REVLITE Q-SWITCHED ND: YAG LASER SYSTEM WITH NADPIECE ADAPTOR (K103118)Hoya Photonics, Inc.2010-11-19+ Add
DIODE LASER THERAPY SYSTEM (K102669)China Daheng Group, Inc.2010-11-17+ Add
EMATRIX CO2 (K101321)Syneron Medical, Ltd.2010-11-09+ Add
ENDOVASCULAR LAER VEIN SYSTEM KIT (K101712)Biolitec, Inc.2010-10-27+ Add
WAVELIGHT FS200 LASER SYSTEM MODEL: FS200 (K101006)Alcon Research, Ltd.2010-10-21+ Add
PINPOINTE FOOTLASER MODEL 6W, 30W, 100W (K093545)Incisive, Inc. (Formerly Named Incisive, LLC)2010-10-15+ Add
MODIFIED ALMA LASERS FAMILY OF SOPRANO XL MULTI-APPLICATION PLATMFORMS (K102716)Alma Lasers, Inc.2010-09-28+ Add
DOCTOR SURGERY DIODE LASERS FAMILY (K102036)Lambda S.P.A.2010-09-28+ Add
AFFIRM DO DIODE LASER (K101601)Cynosure, Inc.2010-09-23+ Add
ACCUSCULPT II LASER SYSTEM (K101573)Lutronic Corporation2010-09-23+ Add
E-LIGHT LINE (K092734)Espansione Marketing S.P.A2010-09-20+ Add
CO2 LASER SYSTEM (K101555)Advanced Technology Laser Co., Ltd.2010-09-17+ Add
CERALAS D/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS HPD/ 980NM (K100726)Biolitec, Inc.2010-09-15+ Add
COOLTOUCH MODEL CT3PZ, COOLTOUCH CT3 PLUS COOLBREEZE (K101783)New Star Lasers, Inc.2010-09-13+ Add
STLASE DIODE LASER (K094049)Dental Photonics, Inc.2010-09-10+ Add
NATURALASE DIODE LASER FAMILY NATURALASE MODEL NL980, NATURALASE DIODE LASER FAMILY NATURALASE NL810 (K101152)Focus Medical, LLC2010-08-18+ Add
PLASMALIPO/PLASMA D30 LSER SURGICAL DEVICE (K100098)Jm System Co., Ltd.2010-08-13+ Add
PILOT DIODE LASER, MODEL 002-00139 (K100143)CAO Group, Inc.2010-08-13+ Add
WATERLASE MD TURBO PLUS MODEL 7200XXX (K101658)Biolase Technology, Inc.2010-08-11+ Add
Q-SWITCHED ND:YAG LASER SYSTEM, MODEL GLOBALCURE-SC6 (K102050)Advanced Technology Laser Co., Ltd.2010-07-29+ Add
QUANTA DIODE LASER SYSTEM (K100558)Quanta System Spa2010-07-22+ Add
SUPRA SCAN DELIVERY SYSTEM (K100678)Quantel Medical2010-07-21+ Add
LASEMAR 800, 1000, 1500 (K092860)Eufoton S.R.L.2010-07-16+ Add
THERACLEAR (K101415)Theravant Corporation2010-07-08+ Add
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