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GEX

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

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RecordFirmDateBuilder
CYNOSURE PHOTOGENICA VL (K012806)Cynosure, Inc.2001-11-19+ Add
DIOMED 15 PLUS AND DIOMED 30PLUS LASERS (K013499)Diomed, Inc.2001-11-16+ Add
CYNOSURE PHOTOGENICA ER (K012790)Cynosure, Inc.2001-11-16+ Add
VISULAS 532S (K013402)Carl Zeiss, Inc.2001-11-14+ Add
REPROCESSED LASER PROBE (K012682)Sterilmed, Inc.2001-11-08+ Add
PARADIGM-FONTONA PEROVSKITE ND: YAP LASER SYSTEM AND ACCESSORIES (K011174)Fotona D.D.2001-11-07+ Add
DRT4 LASER DOPPLER PERFUSION AND TEMPERATURE MONITOR (K011070)Moor Instruments, Ltd.2001-11-07+ Add
ARAMIS DERMATLOGIC LASER (K012545)Lumedics, Ltd.2001-11-05+ Add
SCITON IMAGE HAIR REMOVAL LASER (K012552)Sciton, Inc2001-11-05+ Add
W.O.M. LASER U100 (K011175)W.O.M. World of Medicine GmbH2001-11-01+ Add
CANDELA CLEARBEAM PULSED DYE LASER (K013043)Candela Corp.2001-10-11+ Add
LASER 20 (K011021)Ya-Man, Ltd.2001-10-09+ Add
AL-40 (K010715)Ddc Technologies, Inc.2001-10-04+ Add
PULSEMASTER ERBIUM DENTAL LASER SYSTEM (K012127)American Dental Technologies, Inc.2001-10-04+ Add
MEGABEAM/CERALAS REUSEABLE HANDPIECE AND DISPOSABLE TIPS (K010804)Biolitec, Inc.2001-10-04+ Add
COOLTOUCH VARIZOOM (K012982)New Star Lasers, Inc.2001-10-02+ Add
PALOMAR DERMALUX PULSED LIGHT SYSTEM (K010618)Palomar2001-09-10+ Add
CYNOSURE ACCLAIM DERMATOLOGY LASER (K011828)Cynosure, Inc.2001-09-07+ Add
PALOMAR LC 100 DIODE LASER (K011747)Palomar Medical Technologies, Inc.2001-08-30+ Add
OPUS 10 (WITH TOOTH WHITENING APPLICATION), MODEL 2ND (K011769)Opusdent , Ltd.2001-08-30+ Add
LUMENIS VERSAPULSE POWERSUITE HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) SURGICAL LASERS AND DELIVERY DEVICES (K011703)Lumenis2001-08-29+ Add
INTRALASE 600C LASER KERATOME (K002890)Intra Lase Corp.2001-08-09+ Add
INPULSE DENTAL LASER (K011423)Incisive, LLC2001-08-07+ Add
XTRAC EXCIMER LASER SYSTEM, MODEL AL 7000 (K011382)Photo Medex, Inc.2001-08-02+ Add
LASER PERIPHERALS REUSABLE HOLMIUM FIBER (K011207)Laser Peripherals, LLC2001-07-24+ Add
CANDELA SPTL-1E PULSED DYE LASER (K011092)Candela Corp.2001-07-09+ Add
WATERLASE, MILLENNIUM (K011041)Biolase Technology, Inc.2001-07-03+ Add
MEDLITE Q-SWITCHED ND:YAG LASER REPLACED BY THE MEDLITE C3 Q-SWTICHED ND:YAG LASER (K011677)Continuum Electro-Optics, Inc.2001-06-22+ Add
MODIFICATION TO PROLITE PULSED LIGHT SYSTEM (K010927)Medical Bio Care Sweden AB2001-06-19+ Add
PROLITE VL PULSED LIGHT SYSTEM (K010928)Medical Bio Care Sweden AB2001-06-19+ Add
SLT LASERPRO CTH HOLMIUM LASER SYSTEM (K011409)Surgical Laser Technologies, Inc.2001-06-14+ Add
UNI-LASER 470 (K010885)Medart Corp.2001-06-07+ Add
PHOTON MULTI-PLATFORM SYSTEM, MODEL Z-12834-X & Z-13175-X (K003318)Paradigm Medical Industries, Inc.2001-05-22+ Add
PALOMAR SLP 1000 (K010580)Palomar Medical Technologies, Inc.2001-05-22+ Add
LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES (K010834)Laserscope2001-05-21+ Add
MEGABEAM/CERALAS NON STERILE FIBER OPTIC LASER DELIVERY SYSTEMS, MODEL 200,320,400 OR 600UM (K010689)Biolitec, Inc.2001-05-18+ Add
COOLTOUCH VARIA ND:YAG LASER SYSTEM; COOLTOUCH VARIA-II ND:YAG LASER SYSTEM (K010316)Cooltouch Corp.2001-05-01+ Add
LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION) (K010284)Laserscope2001-05-01+ Add
SOFTLASE - SURGICAL DIODE LASER SYSTEM (K003440)Zap Lasers, Inc.2001-04-20+ Add
LASER MECHANISMS LASER SCANNING SYSTEM (K010113)Laser Mechanisms, Inc.2001-04-12+ Add
CANDELA LONG PULSE ND:YAG (K010104)Candela Corp.2001-04-11+ Add
NUVOLASE 532 MEDICAL LASER SYSTEM (K010046)American Laser Corp.2001-04-05+ Add
CYNOSURE PHOTOGENICA DL (K010005)Cynosure, Inc.2001-04-02+ Add
CYNOSURE PHOTOGENICA NEO-V (K004039)Cynosure, Inc.2001-03-29+ Add
F1 DIODE LASER SYSTEM (K004021)Opus Medical, Inc.2001-03-27+ Add
DORNIER MEDILAS D SKINPULSE LASER SYSTEM (SKINPULSE) (K003993)Dornier Surgical Products, Inc.2001-03-26+ Add
SELECTA 7000 FREQUENCY DOUBLED, Q-SWITCHED ND:YAG OPHTHALMIC LASER (K004006)Lumenis, Inc.2001-03-26+ Add
INDIGO DIFFUSER-TIP FIBEROPTIC WITH TEMPERATURE SENSING OPTION, MODEL LF001 (K003953)Ethicon Endo-Surgery, Inc.2001-03-16+ Add
MD 30 COMPACT (K004014)General Project2001-03-16+ Add
INDIGO LASEROPTIC TREATMENT SYSTEM (K003952)Ethicon Endo-Surgery, Inc.2001-03-16+ Add
LASEREX INTEGRE, MODEL LP2532 (K003955)Ellex Medical Pty, Ltd.2001-03-15+ Add
LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM (K003614)Coherent Star2001-03-13+ Add
SLT DIFFUSER FIBER (K010041)Surgical Laser Technologies, Inc.2001-03-07+ Add
LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION) (K003765)Laserscope2001-03-06+ Add
CONTOUR PROFILE LASER (K010285)Sciton, Inc2001-03-01+ Add
COOLTOUCH ND:YAG LASER SYSTEM, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH II (K003715)Cooltouch Corp.2001-03-01+ Add
PALOMAR SPALIGHT PULSED LIGHT SYSTEM (K003886)Palomar Medical Technologies, Inc.2001-03-01+ Add
XTRAC EXCIMER LASER SYSTEM, MODEL AL7000 (K003705)Photo Medex, Inc.2001-03-01+ Add
VISULAS YAG II (K003885)Carl Zeiss, Inc.2001-02-22+ Add
PALOMAR CLEAR LIGHT ND: YAG LASER SYSTEM (K003460)Palomar Medical Technologies, Inc.2001-01-25+ Add
DENLASER, MODEL 800 (K003541)CAO Group, Inc.2001-01-25+ Add
TWILITE, TWILITE WHITE (K003385)Biolase Technology, Inc.2001-01-25+ Add
FAMILY OF ALTUS MEDICAL COOLGLIDE AESTHETIC LASERS, MODELS I & II (K003202)Altus Medical2001-01-10+ Add
MICROPOBE SERIES OF LASERS AND ACCESSORIES (K003151)Endooptiks, Inc.2001-01-08+ Add
COOLTOUCH VARIA-II ND:YAG LASER SYSTEM (K003781)Cooltouch Corp.2000-12-20+ Add
OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HOLMIUM LASER SYSTEM, MODEL 1210-VHP AND 1500-A (K002308)Trimedyne, Inc.2000-12-20+ Add
LYRA SERIES SURGICAL LASER SYSTEM (SL SERIES, ND:YAG CONFIGURATION) (K003147)Laserscope2000-12-15+ Add
OPUS 20, MODEL 1ST (K002899)Opusdent , Ltd.2000-12-12+ Add
SCITON IMAGE HAIR REMOVAL LASER (K002853)Sciton, Inc2000-12-04+ Add
PARADIGM-FOTONA YAPLASE ND:YAP LASER SYSTEM AND ACCESSORIES (K002884)Fotona D.D.2000-12-04+ Add
MODIFICATION TO INTRALASE 600C LASER KERATOME (K001211)Intra Lase Corp.2000-12-04+ Add
IMAGE VASCULAR LASER (K003046)Sciton, Inc2000-11-24+ Add
ARAMIS DERMATOLOGICAL LASER (K002649)Palomar Medical Technologies, Inc.2000-11-21+ Add
FRIENDLY LIGHT ER:YAG PULSED LASER (K000023)Innotech USA, Inc.2000-11-06+ Add
CANDELA MID IR DIODE LASER SYSTEM (K002421)Candela Corp.2000-11-03+ Add
OMNIPULSE HOLMIUM LASER SYSTEM, OMNIPULSE-MAX HOLMIUM LASER SYSTEM, MODEL 1210, 1210-VHP, 1500-A (K001676)Trimedyne, Inc.2000-11-02+ Add
SPECTRA-VRM Q-SWITCHED ND:YAG LASER SYSTEM, SPECTRA-VRM (K000317)Tissue Medical Lasers, Inc.2000-10-27+ Add
DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES (K001990)Depilase Group , Ltd.2000-10-23+ Add
PROLITE PULSED LIGHT SYSTEM (K000929)Medical Bio Care Sweden AB2000-10-17+ Add
PHOTON MODULAR WORKSTATION SYSTEM, MODELS Z-12834-X & Z-13175-X (K002228)Paradigm Medical Industries, Inc.2000-10-06+ Add
CERALAS G15 532NM FREQUENCY DOUBLED ND:YAG LASER, MODEL G1-G15 (K002296)Ceram Optec, Inc.2000-10-02+ Add
CANDELA SPTL-1B PULSED DYE LASER (K001093)Candela Corp.2000-09-19+ Add
BUFFLIGHT CLT SURGICAL LASER SYSTEM (K000727)Y-Beam Technologies, Inc.2000-09-19+ Add
VIRIDIS LASER (K001784)Cosmos Medical Technology2000-09-11+ Add
C02 LASER MULTIPULSE (K002032)Asclepion-Meditec AG2000-09-11+ Add
PROLITE VL PULSED LIGHT SYSTEM (K002072)Medical Bio Care Sweden AB2000-09-11+ Add
ATHOS (K001704)Cosmos Medical Technology2000-08-31+ Add
NLITE SYSTEM, SLS MODEL NUMBER A00-1025 (K000811)Sls Biophile , Ltd.2000-08-25+ Add
VEINLASE, MODEL E50-K8-B5, SPECTRUM K8, MODEL E50-K8-B9 (K000158)Fisma, Inc.2000-08-24+ Add
CANDELA DYNAMIC COOLING DEVICE (K001589)Candela Corp.2000-08-18+ Add
COOLTOUCH II (K002347)New Star Lasers, Inc.2000-08-17+ Add
CERALAS D10 810NM LASER, MODEL CERALAS D10-60 (K001975)Ceram Optec, Inc.2000-08-04+ Add
FOTONA FIDELIS ER: YAG LASER SYSTEM AND ACCESORIES (K001527)Fotona D.D.2000-07-27+ Add
EPI-STAR SURGICAL LASER SYSTER (K990119)Nidek, Inc.2000-07-27+ Add
O-LAS OPHTHALMIC PHOTODISRUPTOR (K001511)A.R.C. Laser AG2000-07-19+ Add
LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM (FAMILY OF PRODUCTS) (K001746)Coherent Star2000-07-19+ Add
SURGILIGHT, INC EXCIMER LASER (K993328)Surgilight, Inc.2000-07-18+ Add
PERFORMER 30 HPS (K001322)Cornelia Damsky, Inc.2000-06-30+ Add
CYNOSURE APOGEE-TKS DERMATOLOGICAL LASER (K992757)Cynosure, Inc.2000-06-29+ Add
LASER PHOTOLYSIS SYSTEM, PHARO OPHTHALMIC SURGERY SYSTEM (K993154)A.R.C. Laser Corp.2000-06-29+ Add
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