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GEX

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

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RecordFirmDateBuilder
EZLASE 10W (K083069)Biolase Technology, Inc.2008-11-13+ Add
BEAMAX/ FORMAX PULSED LIGHT DEVICE FAMILY (K082876)Sharplight Technologies, Ltd.2008-11-10+ Add
LS FAMILY OF CO2 LASERS WITH SCANNING HANDPIECE (K082101)Sandstone Medical Technologies, LLC2008-11-05+ Add
LASERPRO 810, 940 AND 980 DIODE LASER SYSTEMS (K082721)Photo Medex, Inc.2008-10-28+ Add
CERALAS E 980NM DIODE LASER, MODELS E15/980 AND E30/980 (K082263)Biolitec, Inc.2008-10-24+ Add
PROFILE MULTI-PLATFORM SYSTEM (K081352)Sciton, Inc2008-10-23+ Add
FLASH N' GO (K082298)Home Skinovations , Ltd.2008-10-23+ Add
ELLIPSE MULTIFLEX (K081408)Ellipse A/S2008-10-17+ Add
STRAIGHT FIRE HOLMIUM LASER FIBER (K082928)Boston Scientific Corp2008-10-16+ Add
EVIS MD PLANTIUM BLUE (K082232)Ageless Beauty Corporation2008-10-15+ Add
CURATIVE980 DIODE LASER (K082445)Oroscience, Inc.2008-10-15+ Add
EVIS MD PLATINUM RED LIGHT THERAPY (K082247)Ageless Beauty Corporation2008-10-08+ Add
POWERLIPO LASER SYSTEM (K082096)Lutronic Corporation2008-10-08+ Add
LUMAPROBE (K073000)Clareblend, Inc.2008-10-01+ Add
CLAREBLEND LED PROBES MODEL# 7201-415, 7204-631, 7205-830 (K073022)Clareblend, Inc.2008-10-01+ Add
SMOOTHKIT+ (K082004)Osyris2008-09-26+ Add
SELLAS (K080382)Dinona Co., Ltd.2008-09-24+ Add
CLARO (K080638)Clrs Technology Corporation2008-09-17+ Add
MATRIX RF APPLICATOR (K073572)Syneron Medical, Ltd.2008-09-17+ Add
SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS (K081704)Lumenis, Inc.2008-09-11+ Add
PASCAL SYNTHESIS DELIVERY SYSTEM (K081744)Optimedica Corporation2008-09-09+ Add
STARLIGHT, MODEL PD9012 (K073317)F.P. Rubinstein Y Cia S.R.L.2008-09-03+ Add
CLAROS NANO DENTAL LASER SYSTEM (K081652)Elexxion AG2008-08-28+ Add
SCULPTURE 2.94 ER:YAG SYSTEM (K073158)Hoya Conbio, Inc.2008-08-27+ Add
MEDILAS D FAMILY LASERS (K073427)Dornier Medtech America, Inc.2008-08-20+ Add
MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE (K080530)Cutera, Inc.2008-08-15+ Add
OMNIGUIDE BEAMPATH FIBER OPTIC HANDPIECE SYSTEM AND STERILIZATION TRAY (K081939)Omniguide, Inc.2008-08-12+ Add
ATRILAZE LASER ABLATION SYSTEM (K081457)Medical Cv, Inc.2008-08-08+ Add
LASERPEEL SOFT-MET MODIFIED ERBIUM LASER (K082028)Global USA Distribution, LLC2008-08-08+ Add
FAMILI OF IRIDEX IQ LASER SYSTEMS (K071687)Iridex Corp2008-08-07+ Add
NANNOLIGHT INTENSE PULSED LIGHT SYSTEM (K082033)Global USA Distribution, LLC2008-07-31+ Add
ALMA LASERS THERMOXEL CO2 LASER SYSTEM AND DELIVERY DEVICE ACCESSORIES (K080463)Alma Lasers , Ltd.2008-07-23+ Add
CHROMOLITE EP (K081619)Chromogenex Technologies Limited2008-07-18+ Add
PHARAON 980 ENDO/EXO, OSYFIBRE 600, CONTROL4+ HANDPIECE (K080731)Osyris2008-07-17+ Add
FENCER 308 EXCIMER LASER SYSTEM (K080975)Kera Harvest/Laser Max Medical Technologies Corp2008-07-15+ Add
KEY LASER III 1243 US WITH DETECT (K073074)Kavo America2008-07-10+ Add
CERALAS D 980NM DIODE LASER, MODELS D15 AND D25 (K081015)Biolitec, Inc.2008-07-08+ Add
MOSAIC ECO2 LASER SYSTEM (K080496)Lutronic Corporation2008-07-07+ Add
FRAXEL RE:PAIR (FRAXEL III SR) LASER SYSTEM AND ACCESSORIES (K080915)Reliant Technologies, Inc.2008-07-01+ Add
APOLLO MINI IPL SYSTEM (K081219)Sandstone Medical Technologies, LLC2008-06-30+ Add
ALMA LASERS FAMILY OF THERMO-XEL HANDPIECES, PIXEL MODELS: 2940, 1060 (K072182)Alma Lasers , Ltd.2008-06-27+ Add
DORNIER MEDILAS D 30 LASER, MEDILAS D 1064 (K080959)Dornier Medtech America, Inc.2008-06-27+ Add
AESCULIGHT FAMILY OF FLEXIBLE FIBERS, HANDPIECES AND TIPS FOR CO2 SURGICAL LASERS (K081612)Aesculight, LLC2008-06-25+ Add
PALOMAR LUX 1540 HANDPIECE (K080244)Palomar Medical Products, Inc.2008-06-20+ Add
ACCELA SYSTEM (K081578)Genesis Biosystems, Inc.2008-06-20+ Add
MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPO (K081628)New Star Lasers, Inc.2008-06-20+ Add
CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASERS (K081324)Candela Corp.2008-06-17+ Add
WATERLASE, VERSION 3.0 (K081589)Biolase Technology, Inc.2008-06-13+ Add
MOSAIC LASER SYSTEM (K080932)Lutronic Corporation2008-06-09+ Add
PALOMAR ASPIRE LASER PLATFORM (K081416)Palomar Medical Products, Inc.2008-05-29+ Add
ALMA LASERS HARMONY XL MULTI-APPLICATION PLATFORM (K072564)Alma Lasers , Ltd.2008-05-23+ Add
BIOSYAG MEDICAL SYSTEM (K080374)Bios S.R.L.2008-05-15+ Add
STYLA MICROLASER AND STYLAORTHO (K081214)Zap Lasers, LLC2008-05-14+ Add
LITEDUO (K073411)Light Instruments2008-05-13+ Add
PHOTONOVA FAMILY OF PULSED LIGHT SYSTEMS (K073477)Photonova Ofsweden AB2008-05-09+ Add
SMART CO2 (SMART US 20D / ULTRASPEED, SMART CLINIC AND PERIOPULSE) SURGICAL LASER (K081181)Cynosure, Inc.2008-05-05+ Add
ZELTIQ AESTHETICS CLN1 DERMAL COOLING DEVICE (K080118)Zeltiq Aesthetics2008-05-02+ Add
IFS LASER SYSTEM (K073404)Intra Lase Corp.2008-04-25+ Add
SPECTRA VRMIII Q-SWITCHED ND: YAG LASER SYSTEM AND DYE HANDPIECES (K080248)Lutronic Corporation2008-04-23+ Add
ELIPO (K073715)Syneron Medical, Ltd.2008-04-23+ Add
50W CERALAS D 1950NM DIODE LASER (K072682)Biolitec, Inc.2008-04-18+ Add
COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W (K080525)Cook Urological, Inc.2008-04-17+ Add
PALOMAR ASPIRE LASER PLATFORM (K080567)Palomar Medical Products, Inc.2008-04-16+ Add
COOLTOUCH MODELS LC215 AND COOLLIPO (K080163)New Star Lasers, Inc.2008-04-10+ Add
PHARAON LIPO (K073617)Osyris2008-04-09+ Add
SKIN CLEAR SRVH LONG-PULSED ND: YAG LASER (K080697)Global USA Distribution, LLC2008-04-07+ Add
CRYOMINI (K080735)Zimmer Elektromedizin GmbH2008-04-04+ Add
CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS (K073534)Candela Corp.2008-04-03+ Add
VARI-LASE ENDOVENOUS LASER CONSOLE, MODEL 7542 (K080104)Vascular Solutions, Inc.2008-03-26+ Add
MODIFICATION TO PALOMAR LUX1540 HANDPIECE (K073583)Palomar Medical Products, Inc.2008-03-26+ Add
IPULSE, MODEL I400 (K080406)Cyden Limited2008-03-10+ Add
XTRAC ULTRA 2, MODEL AL10000 (K073659)Photo Medex, Inc.2008-03-05+ Add
FOTONA FIDELIS III ER:YAG/ND:YAG LASER SYSTEM FAMILY (K070355)Fotona D.D.2008-03-04+ Add
AFFIRM WITH XPL HANDPIECE AND ER:YAG LASER MODULE (K080006)Cynosure, Inc.2008-02-28+ Add
Q-PLUS T (K073549)Quanta System Spa2008-02-28+ Add
PETERIO UNIVERSAL LASER SCANNING HANDPIECE (K073048)Scilex, Ltd.2008-02-28+ Add
15W CERALAS D 1470NM DIODE LASER (K073063)Biolitec, Inc.2008-02-27+ Add
FOX 1-980, FOX Q-1064, FOX-Q-810 (K073322)A.R.C Laser GmbH2008-02-22+ Add
FOX 940, MODEL 940 (K071896)Valam, Inc.2008-02-22+ Add
V-RASER DIODE LASER SYSTEM (K073332)Hoya Conbio, Inc.2008-02-14+ Add
WATERLASE AND WATERLASE MD (K071363)Biolase Technology, Inc.2008-02-12+ Add
SPECTRA HAIR REMOVAL LASER (K053527)Spectragenics, Inc.2008-02-01+ Add
CYNOSURE SMARTLIPO MULTIWAVLENGTH LASER (K080121)Cynosure, Inc.2008-01-31+ Add
WATERLASE MD DERM (K071734)Biolase Technology, Inc.2008-01-25+ Add
CERALAS D 980NM DIODE LASER, MODELS D15 AND D25 (K072779)Biolitec, Inc.2008-01-24+ Add
P-NAIN SYSTEM (K072833)Jeisys Medical, Inc.2008-01-24+ Add
SILK'N (K072906)Home Skinovations , Ltd.2008-01-23+ Add
OPTILITE HOLMIUM LASER FIBERS (K073496)Cook Urological, Inc.2008-01-23+ Add
IPULSE, QUADRA Q4 PLATINUM SERIES, MODEL(S) 1200+SERIES 2, 1300 SERIES 2, Q4 SERIES 2 (K071883)Cyden Limited2008-01-23+ Add
ANGIODYNAMICS, INC., NEVERTOUCH II 400UM FIBER AND VENACURE PROCEDURE KIT (K073464)AngioDynamics, Inc.2008-01-23+ Add
CANDELA-INOLASE SERENITY PRO PSF SYSTEM (K072925)Inolase, Ltd.2008-01-10+ Add
VARI-LASE WIRE FIBER (K072332)Vascular Solutions, Inc.2008-01-10+ Add
RADIANCY MISTRAL DEVICE (K072331)Radiancy (Israel) , Ltd.2008-01-07+ Add
COOLTOUCH MODELS NS 160 AND LC215 COOLIPO (K072751)New Star Lasers, Inc.2008-01-02+ Add
MARK III WAVEGUIDE FIBER WITH LOW PROFILE TIP (K073313)Omniguide, Inc.2008-01-02+ Add
SPECTRA VRMII 1-SWITCHED ND:YAG LASER SYSTEM (K073436)Lutronic Corporation2007-12-28+ Add
CYNOSURE YAG FAMILY LASER (K072484)Cynosure, Inc.2007-12-27+ Add
SMART CO2 (SMARTXIDE, SMART US20D) WITH DOT SCANNER (K072159)El.En Electronic Engineering Spa2007-12-27+ Add
TWINWAVE DENTAL LASER, TIDALWAVE 810 DENTAL LASER, TIDALWAVE 980 DENTAL LASER (K072995)Lumen Development and Manufacturing, Inc.2007-12-18+ Add
OMNIGUIDE STERILE WAVEGUIDE ADAPTER SYSTEM (K073409)Omniguide, Inc.2007-12-14+ Add
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