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GEX

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

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RecordFirmDateBuilder
COOLTOUCH VARIA ND:YAG LASER SYSTEM (K060966)Cooltouch, Inc.2006-07-31+ Add
DEL SOL BLUE LIGHT THERAPY SYSTEM (K061470)Edge Systems Corporation2006-07-20+ Add
HIGHLAND BEAM DELIVERY SYSTEM, MODEL 3-099-002-00-00 (K061909)Omniguide, Inc.2006-07-19+ Add
DENLASER 800 PLUS (K061366)CAO Group, Inc.2006-07-10+ Add
LUMENIS ONE FAMILY OF SYSTEMS; LUMENIS ONE. (K060448)Lumenis, Ltd.2006-07-06+ Add
OCULASE MD (K052354)Biolase Technology, Inc.2006-07-05+ Add
NANOLITE SKIN CARE SYSTEM (K061117)Nanolite Technology, Inc.2006-06-20+ Add
ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT (K061178)AngioDynamics, Inc.2006-06-12+ Add
IRIDEX OTOPROBE LONG AND SHORT ANGLES, P/N 14310-1 AND 14320-1 (K060905)Iridex Corp2006-05-31+ Add
JUNIPER COOLING DEVICE (K060407)Juniper Medical Technology, Inc.2006-05-31+ Add
ACMI DUR-HL LASER SYSTEMS (K060752)Acmi Corporation2006-05-25+ Add
PHOTOSILK PLUS PULSED LIGHT SYSTEM AND LASER ATTACHMENT (K051442)Cynosure, Inc.2006-05-24+ Add
MEDLITE C SERIES COMPRESSION TOOL AND HANDPIECE ATTACHMENT ACCESSORY, MODEL 659-0523 (K060977)Hoya Conbio, Inc.2006-05-24+ Add
ELLIPSE 12PL, MODEL 9ESL7228 (K060516)Danish Dermatologic Development A/S2006-05-15+ Add
DEPILITE EL-8B SERIES DERMO FLASH SYSTEMS (K052371)Hair International Systems USA, Inc.2006-05-04+ Add
SPECTRAGENICS ATS-1 (K060567)Spectragenics, Inc.2006-04-28+ Add
ATRILAZE SURGICAL ABLATION SYSTEM (K060680)Medical Cv, Inc.2006-04-11+ Add
VECTRA LASER SYSTEM (K060114)Xintec Corporation, Dba,2006-04-07+ Add
LIGHTSHEER DUET LASER SYSTEM (K053628)Lumenis, Inc.2006-04-07+ Add
LASERTX - DIODE LASER & DELIVERY SYSTEM (K060326)Prosurg, Inc.2006-04-05+ Add
FRAXEL II SR LASER SYSTEM AND ACCESSORIES (K060310)Reliant Technologies, Inc.2006-03-29+ Add
PALOMAR LUX1540 HANDPIECE (K060301)Palomar Medical Technologies, Inc.2006-03-23+ Add
RADIANCY CLEARTOUCH LITE ACNE CLEARANCE SYSTEM (K060411)Radiancy (Israel) , Ltd.2006-03-22+ Add
PHOTEX DIODE LASER SERIES, MODELS 980, 810 AND 940 (K060304)Biotex, Inc.2006-03-21+ Add
MULTISTAR (K060455)Asclepion Laser Technologies GmbH2006-03-20+ Add
QUADROSTAR 532 (K060457)Asclepion Laser Technologies GmbH2006-03-20+ Add
FRAXEL SR LASER SYSTEM (K053047)Reliant Technologies, Inc.2006-03-20+ Add
QUADROSTAR 980 (K060459)Asclepion Laser Technologies GmbH2006-03-20+ Add
ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM (K060216)Energist, Ltd.2006-03-16+ Add
LASEREX DUO FAMILY OF DUAL WAVELENGTH OPHTHALMIC LASERS INCLUDING MODELS INTEGRE DUO LP1RG-S, LP1RG-D (K052777)Ellex Medical Pty, Ltd.2006-03-16+ Add
CRYOFLOW 700, CRYOFLOW 1000 (K052310)Uniphy Elektromedizin GmbH & Co. KG2006-03-15+ Add
MCCUE ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM (K060234)Mccue Plc2006-03-15+ Add
POLARIS WR, ST APPLICATOR (K053616)Syneron Medical, Ltd.2006-03-14+ Add
DA VINCI FEMTOSECOND SURGICAL LASER (K053511)Sie Ltd Surgical Instrument Engineering2006-03-10+ Add
FAMILY OF SELECTA LASER SYSTEMS INCLUDING SELECTA 1064, SELECTA SLT, SELECTA DUET, SELECTA DUO, SELECTA TRIO (K060338)Lumenis, Inc.2006-03-09+ Add
PALOMAR LUXIR FRACTIONAL HANDPIECE (K060069)Palomar Medical Technologies, Inc.2006-03-02+ Add
VISUALASE COOLED LASER APPLICATOR SYSTEM, LASER DIFFUSING FIBER, COOLING CATHETER SYSTEM (K053087)Biotex, Inc.2006-03-01+ Add
PROFILE MULTI-PLATFORM SYSTEM (K060033)Sciton, Inc2006-02-28+ Add
CRYO, MODEL V6.0 (K060395)Zimmer Elektromedizin GmbH2006-02-24+ Add
WAVELIGHT IDAS (K053604)Wavelight Laser Technologie AG2006-02-22+ Add
FOTONA QX ND:YAG/KTP LASER SYSTEM (K053139)Fotona D.D.2006-02-16+ Add
CYNOSURE PHOTOGENICA V-STAR LASER (K053608)Cynosure, Inc.2006-02-13+ Add
MDL SERIES DIODE LASERS, MODEL MDL-10/15 (K042114)Vision Lasertechnik, GmbH2006-02-03+ Add
RADIANCY FACIAL SKINCARE DEVICE (K052991)Radiancy (Israel) , Ltd.2006-02-01+ Add
YAG MIR FAMILY LASER (K053421)Cynosure, Inc.2006-02-01+ Add
RADIANCY SKINSTATION WITH PSORIASIS LIGHT UNIT ASSEMBLY (K052442)Radiancy (Israel) , Ltd.2006-01-26+ Add
MEGABEAM SIDEFIBER FIBER OPTIC DELIVERY SYSTEM (K060050)Biolitec, Inc.2006-01-23+ Add
CALCULASE HOLMIUM LASER SYSTEM AND ACCESSORIES (K052680)KARL STORZ Endoscopy-America, Inc.2006-01-23+ Add
SIROLASER (K053161)Sirona Dental Systems GmbH2006-01-18+ Add
CHROMOLITE SYSTEM (K053324)Chromogenex Plc2006-01-05+ Add
QUANTA SYSTEM ETRNA GIOVINEZZA (K051113)Quanta System Spa2006-01-04+ Add
SPECTRA HAIR REMOVAL LASER (K052848)Spectragenics, Inc.2005-12-27+ Add
VAPORMAX II (K053457)Trimedyne, Inc.2005-12-21+ Add
STARLITE 2006 (K052604)Laser Dental Innovations2005-12-16+ Add
ELLIPSE FLEX PPT, MODEL 9ESF7255 (K052688)Danish Dermatologic Development A/S2005-12-12+ Add
SOPRANO HAIR REMOVAL DIODE LASER (K052874)Msq (M2) , Ltd.2005-11-22+ Add
NOVUS 3000 LASER SYSTEM AND DELIVERY DEVICES (K052526)Lumenis, Inc.2005-11-15+ Add
BURANE (K052806)Wavelight Laser Technologie AG2005-10-17+ Add
ATRILAZE MALLEABLE ABLATION PROBE (K052495)Medical Cv, Inc.2005-10-11+ Add
SPECTRAQUATTRO PULSED LIGHT SYSTEM (K052336)Amjet Distribution, LLC2005-10-11+ Add
MED FLASH II INTENSE PULSED LIGHT SYSTEM. (K051508)General Project S.R.L.2005-10-05+ Add
VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100 (K051259)Theralight, Inc.2005-09-20+ Add
AFFINITY QS Q-SWITCHED ND:YAG LASER SYSTEM (K050382)Cynosure, Inc.2005-09-14+ Add
POLARIS LV, LVA APPLICATOR (K052324)Syneron Medical, Ltd.2005-09-14+ Add
MULTIWAVE XR (K051876)Pacific Quantum Instruments, Inc.2005-09-09+ Add
RADIANCY SKINSTATION WITH MODIFIED LIGHT UNIT ADDEMBLY (K051671)Radiancy (Israel) , Ltd.2005-09-02+ Add
LUMENIS 1000 INTEGRATED SLIT LAMP (K052129)Lumenis, Inc.2005-08-30+ Add
DIOMED DELTA 15, MODEL DELTA 15; DIOMED DELTA 30, MODEL DELTA 30 (K051996)Diomed, Ltd.2005-08-18+ Add
100W CERALAS D 980 LASER SYSTEM, MODEL D100 (K050824)Biolitec, Inc.2005-08-10+ Add
OMNILUX REVIVE AND OMNILUX PLUS (K050216)Photo Therapeutics Limited2005-08-09+ Add
VTRAC EXCIMER LAMP SYSTEM (K051428)Photo Medex, Inc.2005-08-09+ Add
COOLTOUCH ND:YAG LASER SYSTEMS, MODELS CT3S AND CTEV (K051434)New Star Lasers, Inc.2005-08-09+ Add
VARI-LASE ENDOVENOUS LASER PROCEDURE KIT (K051287)Vascular Solutions, Inc.2005-07-29+ Add
INTRALASE FS LASER (K041893)Intra Lase Corp.2005-07-29+ Add
DEALIGHT IPL (K043032)Europro, Inc.2005-07-19+ Add
CANDELA FAMILY OF PULSED DYE LASER SYSTEMS: PIGMENTED LESION HANDPIECE ACCESSORY (K051359)Candela Corp.2005-07-13+ Add
RADIANCE ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT (K051268)Radiancy, Ltd.2005-07-06+ Add
FRAXEL SR LASER SYSTEM (K050841)Reliant Technologies, Inc.2005-07-05+ Add
LUMIPHASE-R (K051255)Opusmed, Inc.2005-07-01+ Add
WAVELIGHT AURIGA (K051399)Wavelight Laser Technologie AG2005-06-30+ Add
CYNERGY MULTIPLEX LASER (K050779)Cynosure, Inc.2005-06-27+ Add
REVLIGHT SKIN CARE SYSTEM (K042630)Skincare Technology, Inc.2005-06-27+ Add
MEDLITE C1 Q-SWITCHED ND:YAG LASER (K050696)Hoya Photonics, Inc.2005-06-17+ Add
CANDELA FAMILY OF PULSE DYE LASER SYSTEMS (K050673)Candela Corp.2005-06-13+ Add
FT FIBER OPTIC DELIVERY SYSTEMS (K050738)Fibertech GmbH2005-06-02+ Add
REVOLIX AND REVOLIX JR (K051167)Allmed Systems, Inc.2005-06-01+ Add
ZENO (K043377)Tyrell, Inc.2005-06-01+ Add
ODYSSEY 2.4G, DENLASER ELITE, MODEL 002-00050 (K050453)Ivoclar Vivadent, Inc.2005-05-27+ Add
MEDIOSTAR XT (K050900)Asclepion Laser Technologies GmbH2005-05-16+ Add
ERCHONIA EVRL LASER (K050672)Erchonia Medical, Inc.2005-05-02+ Add
DIODENT II DENTAL LASER SYSTEM (K050274)Hoya Photonics, Inc.2005-04-29+ Add
MODELS CRYSTAL 512, RECORD 618, OPTIMA 518 PHOTO EPILATION SYSTEMS (K050950)Active Optical Systems, Ltd./Efraim Bidas2005-04-29+ Add
AIP INTENSE PULSED LIGHT SYSTEM (K041554)Aesthera Corporation2005-04-27+ Add
MODIFICATION TO IFL PROFESSIONAL SYSTEM, MODEL C100 (K050165)Cyden Limited2005-04-19+ Add
SPECTRA-SP CO2 LASER SYSTEM (K050254)Max Engineering , Ltd.2005-04-15+ Add
OCULIGHT GL/GLX (K050562)Iridex Corp2005-04-14+ Add
AURORA DS, DS APPLICATOR (K050796)Syneron Medical, Ltd.2005-04-12+ Add
CUTERA SOLERA OPUS AESTHETIC PRODUCT (K050679)Cutera, Inc.2005-03-31+ Add
CUTERA OPTIONAL PULSED LIGHT HAND PIECE FAMILY (K050047)Cutera, Inc.2005-03-31+ Add
BIOSYAG 50 MED (K043521)Bios S.R.L.2005-03-24+ Add
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