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GEX

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

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RecordFirmDateBuilder
PROLITE / PLASMALITE MPX PULSED LIGHT SYSTEM (PERMANENT HAIR REDUCTION) (K023081)Medical Bio Care Sweden AB2002-12-16+ Add
W.O.M. LASER U100 (K023041)W.O.M. World of Medicine AG2002-12-11+ Add
FOTONA DUALIS ND:YAG/ER:YAG LASER SYSTEM (K021548)Fotona D.D.2002-12-06+ Add
EVLT KIT AND D15PLUS AND D30PLUS DIODE (K023543)Diomed, Inc.2002-12-02+ Add
FOTONA DUALIS ER:YAG/KTP LASER SYSTEM (K022838)Fotona D.D.2002-11-25+ Add
FOTONA DUALIS PLUS ND:YAG LASER SYSTEM (K022839)Fotona D.D.2002-11-25+ Add
FOTONA TANDEM LASER SYSTEM (K022837)Fotona D.D.2002-11-25+ Add
COOLTOUCH ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH-II (K022817)Icn Pharmaceuticals, Inc.2002-11-22+ Add
EQUILASE SYSTEM (K022464)Equilasers, Inc.2002-11-21+ Add
CYNOSURE PHOTOGENICA SV (K021444)Cynosure, Inc.2002-11-20+ Add
MILLENNIUM MICROSURGICAL SYSTEM (K022760)Bausch & Lomb, Inc.2002-11-18+ Add
TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATH (K022655)Trimedyne, Inc.2002-11-07+ Add
CLARUS STRAIGHT FIRING LASER FIBER, MODEL 1150, CLARUS SIDE FIRING LASER FIBER, MODEL 1160 (K022610)Clarus Medical, LLC2002-11-05+ Add
FLASH 1 (K022583)Emed, Inc.2002-10-31+ Add
LUMENIS ULTRAPULSE ENCORE CARBON DIOXIDE SURGICAL LASERS AND DELIVERY DEVICE ACCESSORIES (K022060)Lumenis, Inc.2002-10-30+ Add
DORNIER DIODE LASER FAMILY MEDILAS D, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEM (K020339)Dornier Medtech America, Inc.2002-10-25+ Add
INDIGO OPTIMA LASER SYSTEM, OPTIMA DIFFUSER-TIP FIBEROPTIC-BPH, OPTIMA BARE-TIP FIBEROPTIC,OPTIMA LASER CART WITH PRINTS (K023182)Ethicon Endo-Surgery, Inc.2002-10-24+ Add
PLASMALITE PULSED LIGHT SYSTEM (K022378)Medical Bio Care Sweden AB2002-10-18+ Add
PROFILE 1320 LASER SYSTEM (K022381)Sciton, Inc2002-10-18+ Add
OPTICAL INTEGRITY GENERAL SHAPED FIBER (K022338)Optical Integrity, Inc.2002-10-16+ Add
NOVUS SPECTRA (K022327)Lumenis, Inc.2002-10-16+ Add
DIODENT DENTAL LASER SYSTEM (K022351)Continuum Electro-Optics, Inc.2002-10-16+ Add
QUANTUM, MODELS SR, HR, DL; VASCULIGHT, MODELS SR, HR, VS, VX, DL (K020839)Lumenis, Inc.2002-10-11+ Add
FAMILY OF IRIS MEDICAL ENDOPROBE HANDPIECES (K022228)Iridex Corp2002-10-08+ Add
ALTUS MEDICAL FAMILY OF COOLGLIDE LASERS, MODELS COOLGLIDE I, COOLGLIDE II, AND FUTURE MODELS (K022226)Altus Medical, Inc.2002-10-08+ Add
CANDELA SMOOTHBEAM LASER SYSTEM (K014128)Candela Corp.2002-10-04+ Add
AURORA SR (K022266)Syneron Medical, Ltd.2002-10-03+ Add
NOVUS VARIA OPHTHALMIC LASER AND DELIVERY DEVICES WITH ACCESSORIES (K022181)Lumenis, Inc.2002-10-01+ Add
RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30; N/A 1500-A (K013974)Trimedyne, Inc.2002-09-23+ Add
LASERSYSTEM BEAUTYSTAR 532 (K021975)Asclepion-Meditec AG2002-09-13+ Add
CELL ROBOTICS ULTRA-LIGHT PEEL LASER SYSTEM (K021946)Cell Robotics, Inc.2002-09-11+ Add
CLARUS STRAIGHT FIRING LASER FIBER; CLARUS SIDE FIRING LASER FIBER; MODELS 1150, 1160 (K021848)Clarus Medical, LLC2002-09-03+ Add
PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF VASCULAR LESIONS (K022569)Medical Bio Care Sweden AB2002-08-29+ Add
PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF UNWANTED HAIR (K022568)Medical Bio Care Sweden AB2002-08-29+ Add
DORNIER MEDILAS H LASER FIBER CABLES (K022544)Dornier Medtech America, Inc.2002-08-21+ Add
LASER FIBER GF500 (K021686)W.O.M. World of Medicine AG2002-08-20+ Add
20G SMA LASER FIBER, MODEL LF20; 25G SMA LASER FIBER, MODEL LF25 (K021696)Ophthalmed, LLC2002-08-20+ Add
DORNIER DIODE LASER FAMILY, INCLUDING MEDILAS D FIBERTOM, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEMS (K021724)Dornier Medtech America, Inc.2002-08-19+ Add
CLEARLIGHT PHOTOTHERAPHY SYSTEM, MODEL CL 420 (K013623)Curelight, Ltd.2002-08-16+ Add
ATHOSCAN FOR THE ATHOS LASER CONSTANS COOLING HAND PIECE FOR THE ATHOS LASER (K021650)Quantel Medical2002-08-16+ Add
CERALAS D DIODE LASER SYSTEM, MODEL # D50 (K013691)Biolitec, Inc.2002-08-13+ Add
LUMENIS SELECTA DUET (K021550)Ellex Medical Pty, Ltd.2002-08-09+ Add
OPUSDUO EC DENTAL LASER SYSTEM (K021508)Opusdent , Ltd.2002-08-07+ Add
PROLITE PULSED LIGHT SYSTEM (K021304)Big Sky Laser Technologies, Inc.2002-07-23+ Add
DELIGHT DENTAL ER: YAG LASER SYSTEM (K021616)Continuum Electro-Optics, Inc.2002-07-11+ Add
AURORA DS (K021149)Syneron Medical, Ltd.2002-07-09+ Add
LYRA SURGICAL LASER SYSTEM AND ACCESSIORIES (ND:YAG CONFIGURATION) (K020021)Laserscope2002-07-02+ Add
CANDELA VBEAM PULSED DYE LASER SYSTEM (K021180)Candela Corp.2002-07-02+ Add
SOFTLASE G2-SURGICAL DIODE LASER SYSTEM (K021227)Zap Lasers, LLC2002-06-26+ Add
CANDELA CBEAM PULSED DYE LASER SYSTEM (K020958)Candela Corp.2002-06-21+ Add
PALOMAR LUXG HANDPIECE (K020941)Palomar2002-06-19+ Add
SPATOUCH PHOTOEPILATION SYSTEM (K020856)Radiancy (Israel) , Ltd.2002-06-13+ Add
CERALAS D10-60 810NM DIODE LASER, MODELCERALAS DIO-60 (K020835)Biolitec, Inc.2002-06-12+ Add
NLITE SYSTEM,MODEL A00-1051 (K020729)Icn Photonics , Ltd.2002-06-04+ Add
FAMILY OF ALTUS MEDICAL MODIFIED COOLGLIDE AESTHETIC LASERS, MODELS COOLGLIDE I, II AND FUTURE MODELS (K014040)Altus Medical, Inc.2002-06-03+ Add
LIGHTLANCE LASER SKIN PERFORATOR (K013021)Innotech USA, Inc.2002-05-30+ Add
WAVE FORM MANUFACTURING PROLASE GENERAL SHAPED FIBER (K020673)Wave Form Mfg., Inc.2002-05-30+ Add
APEX 800 LASER SYSTEM, MODEL APEX 800 (K020849)Iridex Corp2002-05-20+ Add
EPY-50 (K020513)Ddc Technologies, Inc.2002-05-16+ Add
XTRAC EXCIMER LASER SYSTEM, MODEL AL7000 (K020847)Photo Medex, Inc.2002-05-16+ Add
PALOMAR ESTELUX PULSED LIGHT SYSTEM AND PALOMAR COOLROLLER (K020453)Palomar Medical Technologies, Inc.2002-05-10+ Add
MAXIFLEX FIBER OPTIC ENERGY DELIVERY SYSTEM (K013300)Technology Delivery Systems, Inc.2002-04-16+ Add
DEPILASE TWIN YAG LASER SYSTEM (K020697)Depilase Group , Ltd.2002-04-12+ Add
MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE (K020099)Biolitec, Inc.2002-04-11+ Add
ATHOS LASER (K020072)Quantel Medical2002-04-09+ Add
VIRIDIS DERMA LASER (K020071)Quantel Medical2002-04-05+ Add
EX-308 EXCIMER LASER FOR PHOTOTHERAPY TREATMENT OF VITILIGO (K020973)Surgilight, Inc.2002-03-29+ Add
PERIOLASE ND:YAG DENTAL LASER SYSTEM (K014272)Millennium Dental Technologies, Inc.2002-03-27+ Add
CLINICON WAVEGUIDE PLATFORM WITH INTERCONNECT FOR LUXAR ACCESSORIES (K014236)Clinicon Corp.2002-03-26+ Add
DERMACHILLER 4 (K014253)Paradigm Trex, LLC2002-03-26+ Add
CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR (K013201)Cardiofocus, Inc.2002-03-18+ Add
DERMASTAR ER:YAG LASER SYSTEM (K014057)Asclepion-Meditec AG2002-03-08+ Add
COOLTOUCH AND COOLTOUCH-II ND:YAG LASER SYSTEMS (K014035)Cooltouch Corp.2002-03-07+ Add
DEPILASE YAG LASE PLUS LASER SYSTEM (K020463)Depilase Group , Ltd.2002-02-27+ Add
PULSION FS LASER KERATOME (K013941)Intra Lase Corp.2002-02-27+ Add
DIODENT DENTAL LASER SYSTEM (K013216)Continuum Electro-Optics, Inc.2002-02-27+ Add
LASER SYSTEM YELLOWSTAR (K013940)Asclepion-Meditec AG2002-02-26+ Add
DEPILASE TWIN LASE LASER SYSTEM (K020412)Depilase Group , Ltd.2002-02-22+ Add
CANDELA SMOOTHBEAM LASER SYSTEM (K013825)Candela Corp.2002-02-15+ Add
CLINICON UNIVERSAL WAVEGUIDE HANDPIECE AND FIBER TIPS (K014048)Clinicon Corp.2002-02-11+ Add
CANDELA SCLERO LONG PULSE LASER (AKA VBEAM) (K013748)Candela Corp.2002-02-11+ Add
MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-60 (K013864)Nidek, Inc.2002-02-08+ Add
SMARTEPIL (K020107)Cynosure, Inc.2002-02-07+ Add
DIOMED 15 DIODE LASER (K012398)Diomed, Ltd.2002-01-22+ Add
NLITE SYSTEM,MODEL A00-1025 (K013461)Icn Photonics , Ltd.2002-01-17+ Add
MEDLITE IV Q-SWITCHEDND: YAGLASER REPLACED BY THE MEDLITE C6 Q-SWICTHED ND: YAG LASER (K014234)Continuum Electro-Optics, Inc.2002-01-17+ Add
NLITE SYSTEM (K014130)Icn Photonics , Ltd.2002-01-08+ Add
OPUS SPECTRUM (A MODEL OF OPUS 20), MODEL 2ND (K014100)Opusdent , Ltd.2002-01-08+ Add
PROLITE PULSED LIGHT SYSTEM FOR THE TREATMENT OF PIGMENTED LESIONS AND THE REMOVAL OF TATTOOS (K013365)Medical Bio Care Sweden AB2002-01-08+ Add
PROLITE PULSED LIGHT SYSTEM FOR THE REMOVAL OF UNWANTED HAIR (K013366)Medical Bio Care Sweden AB2002-01-08+ Add
FOTONA DUALIS, FOTONA DUALIS PLUS (K011939)Fotona D.D.2001-12-27+ Add
MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE (K013193)Biolitec, Inc.2001-12-21+ Add
LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS POCKETPRO OR POCKETPRO S4) (K011960)Lares Research, Inc.2001-12-21+ Add
MALLEABLE SURGICAL LIGHTSTIC 180, MODEL 180 (1CM-9CM) (K013901)Cardiofocus, Inc.2001-12-20+ Add
INDIGO OPTIMA LASER SYSTEM (K013493)Ethicon Endo-Surgery, Inc.2001-12-13+ Add
FOTONA DUALIS ND:YAG LASER SYSTEM, FOTONA TWINLIGHT ND:YAG LASER SYSTEM (K013047)Mojca Valijavec2001-12-06+ Add
PALOMAR SLP 1000 (K013028)Palomar Medical Products, Inc.2001-12-06+ Add
ENT LASERVISION (K012071)Union Medical USA2001-12-03+ Add
PERIOLASE ND:YAG DENTAL LASER SYSTEM (K010771)Millennium Dental Technologies, Inc.2001-11-27+ Add
DORNIER SAPPHIREERBIUM HANDPIECE, DORNIER SAPPHIRESPOT HANDPIECE (K011322)Dornier Medtech America, Inc.2001-11-19+ Add
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