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GEX

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

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RecordFirmDateBuilder
SMARTLIPO LASER (K073394)Cynosure, Inc.2007-12-12+ Add
MILESMAN PREMIUM (K073300)Milesman S.L.2007-12-04+ Add
APL MEDICAL SYSTEM (K072344)Bios S.R.L.2007-12-03+ Add
NOVEON, MODEL LS1100-01-0968 (K071815)Nomir Medical Technologies, Inc.2007-11-28+ Add
ACCOLADE II LASER (K072868)Cynosure, Inc.2007-11-05+ Add
ERBIUM FRACTIONAL HANDPIECE (K071768)Palomar Medical Products, Inc.2007-11-05+ Add
FRAXEL III SR LASER SYSTEM AND ACCESSORIES (K071051)Reliant Technologies, Inc.2007-11-02+ Add
GENTLERAY 980 DIODE LASER SYSTEM (K072262)Kavo America2007-10-26+ Add
QUASAR BLUE LIGHT THERAPY SYSTEM (K072767)Silver Bay, LLC2007-10-15+ Add
SKIN CARE LIGHT (K070870)Transverse Industries Co.2007-10-10+ Add
RELIANT TECHNOLOGIES C300 CHILLER SYSTEM AND ACCESSORIES (K071621)Reliant Technologies, Inc.2007-10-09+ Add
COOLTOUCH, MODEL LC215,COOLLIPO (K072424)New Star Lasers, Inc.2007-10-03+ Add
VISIOLITE OPHTHALMIC ER: YAG LASER SYSTEM (K070296)Ace Vision Group2007-10-03+ Add
VISULAS TRION (K072514)Carl Zeiss Meditec, AG2007-09-21+ Add
DIODE MEDICAL LASER FAMILY, MODELS 4, 6, 30 (K072034)Quanta System Spa2007-09-20+ Add
ELLIPSE JUVIA, MODEL 9EJU7465 (K072023)Ellipse A/S2007-09-12+ Add
VISUALASE THERMAL THERAPY SYSTEM (K071328)Biotex, Inc.2007-08-31+ Add
150W CERALAS D 980NM DIODE LASER (K072106)Biolitec, Inc.2007-08-30+ Add
TANDA SKINCARE SYSTEM, PLC-001, TANDA BLUE, 414-001, TANDA RED, 660-001 (K070185)Pharos Life Corporation2007-08-21+ Add
INOLASE SERENITY PSF ( PNEUMATIC SKIN FLATTENING) SYSTEM (K071469)Candela Corp.2007-08-15+ Add
SERENITY PRO PSF SYSTEM (K071943)Inolase 2002, Ltd.2007-08-10+ Add
TATTOOSTAR Y (K071451)Asclepion Laser Technologies GmbH2007-08-01+ Add
ANGIODYNAMICS, INC.NEVERTOUCH 600UM FIBER AND VENACURE PROCEDURE KIT (K071959)AngioDynamics, Inc.2007-08-01+ Add
LUMINA INTENSE PULSED LIGHT (& LASER) SYSTEM (K063427)Lynton Lasers Limited2007-07-25+ Add
MOSAIC LASER SYSTEM (K070392)Lutronic Corporation2007-07-13+ Add
ULTRAWAVE II EX 1320 (K070805)Quanta System Spa2007-07-11+ Add
MODIFICATION TO PALOMAR LUXIR HANDPIECE (K070298)Palomar Medical Technologies, Inc.2007-07-03+ Add
FLEXGUARD (K070924)Allmed Systems, Inc.2007-06-21+ Add
PALOMAR ERBIUM HANDPIECE (K071152)Palomar Medical Products, Inc.2007-05-25+ Add
MEDILAS D FAMILY LASERS (K070536)Dornier Medtech America, Inc.2007-05-21+ Add
FRALEX SR 1500 LASER SYSTEM (FRALEX II SR LASER SYSTEM) (K070284)Reliant Technologies, Inc.2007-05-17+ Add
100W CERALAS D 980NM DIODE LASER (K071295)Biolitec, Inc.2007-05-16+ Add
FOX MEDICAL DIODE LASER SYSTEM 810NM (K063104)Howard Instruments, Inc.2007-05-16+ Add
KELSEY INTERSITITAL LASER THERAPY SYSTEM (K070353)Kelsey, Inc.2007-05-02+ Add
PROFILE MULTI-PLATFORM SYSTEM (K070388)Sciton, Inc2007-05-02+ Add
EPI-C PLUS (K070494)Espansione Marketing S.P.A2007-05-01+ Add
FRAXEL IV SR LASER SYSTEM (K063808)Reliant Technologies, Inc.2007-04-27+ Add
FRAXEL III SR LASER SYSTEM AND ACCESSORIES (K063038)Reliant Technologies, Inc.2007-04-27+ Add
REVOLIX DUO LASER SYSTEM (K070466)Allmed Systems, Inc.2007-04-17+ Add
PHAROS EXCIMER LASER SYSTEM, MODEL EX-308 (K062963)Ra Medical Systems,Inc2007-04-03+ Add
CUTERA ER:YSGG LASER HANDPIECE (K063867)Cutera, Inc.2007-03-27+ Add
CUTERA ER:YAG LASER HANDPIECE (K070138)Cutera, Inc.2007-03-27+ Add
REVOLIX 120 (K070476)Allmed Systems, Inc.2007-03-26+ Add
GENESIS DIODE LASER (K062258)Ivoclar Vivadent, Inc.2007-03-21+ Add
VARI-LASE BRIGHT TIP FIBER (K070216)Vascular Solutions, Inc.2007-03-16+ Add
ATRILAZE MI SURGICAL ABLATION SYSTEM (K061489)Medical Cv, Inc.2007-03-16+ Add
DIODENT MICRO DENTAL LASER SYSTEM, MODELS 810 AND 980 (K063384)Hoya Conbio, Inc.2007-03-16+ Add
ANGIODYNAMICS, INC. 600UM FIBER AND VENACURE PROCEDURE KIT (K070378)AngioDynamics, Inc.2007-03-09+ Add
SLIM EVOLUTION FAMILY OF CO2 LASERS AND DELIVERY DEVICE ACCESSORIES (K063001)Lasering S.R.L.2007-03-07+ Add
CLAROS DENTAL LASER SYSTEM (K063152)Elexxion AG2007-03-07+ Add
CO2 LASER SYSTEM, MODEL C-LAS (K063698)Clinicon Corp.2007-03-02+ Add
DERMA YAG (K062762)El.En Electronic Engineering Spa2007-03-01+ Add
PALOMAR LUX1540 HANDPIECE (K061652)Palomar Medical Products, Inc.2007-02-27+ Add
INTRALASE FUSION LASER (K063682)Intra Lase Corp.2007-02-09+ Add
PALOMAR LUX2940 HANDPIECE (K063571)Palomar Medical Technologies, Inc.2007-02-09+ Add
JUNIPER COOLING DEVICE XTRA (K063715)Juniper Medical, Inc.2007-02-05+ Add
CANDELA FLUORESCENT PULSED LIGHT SYSTEM (K063800)Candela Corp.2007-02-05+ Add
OMNIGUIDE BEAM PATH CO2 MARK III WAVEGUIDE FIBER (K070157)Omniguide, Inc.2007-02-01+ Add
COSMELIGHT (K061720)Penntack Enterprises, Inc.2007-01-31+ Add
FRAXEL II SR LASER SYSTEM (K062303)Reliant Technologies, Inc.2007-01-31+ Add
YAG MIR II LASER (K070063)Cynosure, Inc.2007-01-30+ Add
EZLASE (K061898)Biolase Technology, Inc.2007-01-26+ Add
OMNIGUIDE ZERO FLOW ZF-T WAVEGUIDE FIBER (K070071)Omniguide, Inc.2007-01-25+ Add
DIOMED DELTA 25 (K063828)Diomed, Ltd.2007-01-25+ Add
REVLITE C6 Q-SWITCHED ND:YAG LASER SYSTEM (K063834)Hoya Conbio, Inc.2007-01-25+ Add
BEAMAX (K063249)Medic Sharplight , Ltd.2007-01-17+ Add
VELURE FAMILY OF DIODE LASERS AND DELIVERY DEVICE ACCESSORIES (K063396)Lasering S.R.L.2007-01-17+ Add
BWF-5 MEDICAL LASER SERIES, 810 NM; 930 NM; 980 NM; 1080 NM (K062363)B&W Tek, Inc.2007-01-17+ Add
CANDELA 3630 LASER SYSTEM (K063074)Candela Corp.2006-12-27+ Add
HORUS LASER KERATOME (K062314)Carl Zeiss Meditec, AG2006-12-22+ Add
CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS (K063073)Candela Corp.2006-12-20+ Add
CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS: 532 AND 1064 ND:YAG HANDPIECE ACCESSORIES (K063072)Candela Corp.2006-12-20+ Add
LASER-D68 (K061656)Laser Pain Clinics LP2006-12-15+ Add
PALOMAR Q-YAG 5 ND:YAG LASER SYSTEM (K061436)Palomar Medical Technologies, Inc.2006-12-06+ Add
GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIES (K062719)Laserscope2006-12-01+ Add
REVLITE Q-SWITCHED ND:YAG LASER (K063112)Hoya Conbio, Inc.2006-12-01+ Add
SERENITY PSF (PNEUMATIC SKIN FLATTENING) SYSTEM (K062589)Inolase 2002, Ltd.2006-11-30+ Add
OMNIGUIDE ZERO FLOW ZF-T 150 WAVEGUIDE FIBER (K063141)Omniguide, Inc.2006-11-29+ Add
BLUESHINE LIGHT SHINE SYSTEMS, SP, TWIN AND COMPACT SP (K063060)Blueshine Srl2006-11-29+ Add
GREENTON ECOLITE IPL SYSTEM (K062721)Greenton (London) , Ltd.2006-11-21+ Add
VARI-LASE ENDOVENOUS LASER CONSOLE, MODEL 7500 (K062822)Vascular Solutions, Inc.2006-11-21+ Add
DENLASER 800 PLUS (K062619)CAO Group, Inc.2006-11-14+ Add
LUMACARE LC-122M NON-COHERENT LIGHT SOURCE (K062871)Lynton Lasers Limited2006-11-14+ Add
IRIDEX OCULIGHT TX (K062369)Iridex Corp2006-11-08+ Add
SMARTLIPO ND:YAG LASER (K062321)Cynosure, Inc.2006-10-31+ Add
THERMACLEAR (K060653)Dermacare, Inc.2006-10-24+ Add
OPTIMEDICA LASER INDIRECT OPHTHALMOSCOPE (K062336)Optimedica Corporation2006-10-19+ Add
AXIOM PULSED LIGHT SYSTEM (K062312)General Project S.R.L.2006-10-16+ Add
MINI-YAG LASER (K061850)American Lasers, Inc.2006-09-29+ Add
PROMETEY, MODEL G1-03 (K062071)Spectrum International2006-09-28+ Add
LITETOUCH DENTAL LASER SYSTEM (K061966)Light Instrument, Ltd.2006-09-27+ Add
TATTOOSTAR FAMILY (K060787)Asclepion Laser Technologies GmbH2006-09-27+ Add
COOLTOUCH, MODEL CTEV (K061618)New Star Lasers, Inc.2006-09-25+ Add
COOL TOUCH, MODELS CT3S, CTEV, NS160, CTEV, LC160 (K062210)New Star Lasers, Inc.2006-09-25+ Add
OMNIGUIDE BEAMPATH LASER BEAM DELIVERY SYSTEM (K062423)Omniguide, Inc.2006-09-21+ Add
AESTHERA PHOTOPNEUMATIC (PPX) SYSTEM (K062048)Aesthera Corporation2006-09-07+ Add
INTERMEDIC DIODE LASER FAMILY 810NM AND 980NM (AND THE DELIVERY ACCESSORIES THAT ARE USED WITH THEM TO DELIVER LASER ENE (K053540)Intermedic Arfran, SA2006-09-06+ Add
AZURYT MODEL CTL 1401, CO2 SURGICAL LASER SYSTEM (K062248)North American Clinical Lasers, Ltd.2006-08-17+ Add
INTRALASE FS LASER, INTRALASE FS30 LASER, MODELS 1, 2, 3 (K060372)Intra Lase Corp.2006-08-16+ Add
DORNIER MEDILAS H 20 LASER (K061455)Dornier Medtech America, Inc.2006-08-01+ Add
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