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GEX

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

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RecordFirmDateBuilder
TBN-TIPPED OPTICAL FIBER (K952113)Myriad Lase, Inc.1995-06-01+ Add
ACCU-BEAM FIBER OPTIC HANDPIECE (K952006)Tti Medical1995-05-31+ Add
ALEXLAZR (K950831)Candela Laser Corp.1995-05-26+ Add
UROTEK RE-USABLE FIBEROPTIC CABLE (K951933)Energy Life Systems Corp.1995-05-26+ Add
ADD POWER FAMILY , MICRO ADDSTAT (K945614)Laserscope1995-05-15+ Add
SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM FAMILY (K931490)Surgical Laser Technologies, Inc.1995-05-05+ Add
ELLMAN VAPOR-VAC II (K944558)North American Technical Services Corp.1995-04-28+ Add
ACCUCURE 3000 (K943411)Lasermed1995-04-25+ Add
LASERSONICS ULTRALINE III STERILE DISPOSABLE FIBER (K951215)Heraeus Surgical, Inc.1995-04-18+ Add
SLT SIDEFIRING REFRACTIVE FIBER (HIGH POWER DENSITY FIBER) (K950819)Surgical Laser Technologies, Inc.1995-04-18+ Add
AURA LASER SYSTEM (K951034)Laserscope1995-04-13+ Add
SHARPLAN MODEL 1015 CO2 LASER (K950725)Sharplan Lasers, Inc.1995-04-06+ Add
THERMOLASE LT-100 ND:YAG LASER HAIR REMOVAL SYSTEM; THERMOLASE LT-100;LT-100 (K950019)Thermolase Corp.1995-04-03+ Add
LASER GAS MIXTURE (K951045)Liquid Carbonic Industrial Gases1995-03-31+ Add
KAPLAN PENDULASER 115 - A 15W CO2 SURGICAL LASER (K950313)Optomedic Medical Technologies , Ltd.1995-03-24+ Add
CANDELA RUBY LAZE Q-SWITCHED RUBY LASER (K946386)Candela Laser Corp.1995-03-24+ Add
LASEAWAY Q-SWITCHED ND:YAG LASER SYSTEM (K942622)Mdi, Inc.1995-03-24+ Add
CL-5500 (UNMODIFIED DEVICE) PRECISION CURING UNIT (PCU) (MODIFIED OPTION) (K950351)Ion Laser Technology1995-03-24+ Add
125MM HANDPIECE (K945228)Plc Medical Systems, Inc.1995-03-20+ Add
COHERENT FAMILY OF CO2 SURGICAL LASER SCANNER HANDPIECES (K946304)Lumenis, Inc.1995-03-15+ Add
DISPOSABLE LASER SWEEP TIP (K944437)Reliant Technologies, Inc.1995-03-14+ Add
LASERSONICS SURGICAL LASER SYSTEMS AND ACCESSORIES (K943716)Heraeus Surgical, Inc.1995-03-14+ Add
MICROQUARTZ MEDICAL SIDE-FIRING LASER FIBER (K950710)Microquartz Medical, Inc.1995-03-10+ Add
CANDELA 10MM CIRCULAR SPOT LASER HANDPIECE (K950661)Candela Laser Corp.1995-03-10+ Add
DERMASTAT, MICRONSPOT, MACROSPOT, FOCALSTAT (K950662)Laserscope1995-03-10+ Add
SLASE 210 PLUS HOLMIUM LASER SYSTEM (K945156)New Star Lasers, Inc.1995-03-09+ Add
CANDELA SPTL VARIABLE PULSE/TUNABLE PULSED DYE LASERS (K943292)Candela Laser Corp.1995-03-09+ Add
USDL MODEL SELECT 1000 FREQUENCY DOUBLED ND:YAG LASER SYSTEM (K943638)United States Dental Laser, Inc.1995-03-06+ Add
CLEAN AIR (K943201)Wallach Surgical Devices, Inc.1995-02-28+ Add
LASERSPRAY(TM) (K950248)Biolase Technology, Inc.1995-02-24+ Add
50MM HANDPIECE (K950505)Plc Medical Systems, Inc.1995-02-24+ Add
ACCU-BEAM C02 LASER HANDPIECE (K945648)Tti Medical1995-02-24+ Add
TOUCH FOCUS 200MM DEFOCUSING HANDPIECE (K945178)Plc Medical Systems, Inc.1995-02-24+ Add
MEGABEAM FIBER OPTIC DELIVERY SYSTEM (K946336)Hogan & Hartson1995-02-10+ Add
SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM (K931286)Surgical Laser Technologies, Inc.1995-02-06+ Add
MODIFIED LUXAR LX-20 FAMILY C02 LASER SYSTEM (K945888)Luxar Corp.1995-01-27+ Add
PY30, PY60, PY80 (K944928)Huttinger Medizintechnik GmbH & CO KG1995-01-27+ Add
GENERA 100 SURGICAL SYSTEM (K945181)Xintec Corporation1995-01-20+ Add
ECLIPSE 3200 (K945126)Cardiogenes1995-01-18+ Add
UROTEK LASER CATHETER (K945560)Energy Life Systems Corp.1995-01-18+ Add
OPTILITE (TM) VII FIBEROPTIC ACCESSORIES ROTALASE (TM) ANGLE DELIVERY SYSTEMSN AND ACCESSORIES (K944704)Xintec Corporation1995-01-06+ Add
OPTILITE VI FIBEROPTIC ACCESSORIES (K944965)Xintec Corporation1995-01-06+ Add
ORIGIN PREPERITONEAL DISSECTION BALLOON SYSTEM (PDBS)--EXTRA (K946002)Origin Medsystems, Inc.1995-01-05+ Add
SUNRISE TECHNOLOGIES MODEL 5020 PLDD KIT (K944758)Cardiogenes1994-12-27+ Add
OPTICA 100 SUPERPULSED LASER SYSTEM (K944749)Xintec Corporation1994-12-22+ Add
ACUTOME 100 COLOR-CORRECTED CO2 LASER HANDPIECE (K942935)Reliant Technologies, Inc.1994-12-19+ Add
OPTILITE V FIBEROPTIC ACCESSORIES (K944474)Xintec Corporation1994-12-15+ Add
CONVERTIBLE CONTACT SIDE-FIRING REFRACTIVE FIBER (C-SRF(TM)) (K945563)Energy Life Systems Corp.1994-12-15+ Add
MULTIPLE CO2 LAERS (K941838)Mattioli Engineering, Srl1994-12-15+ Add
UNIMAX MODEL 2500 MULTIWAVELENGTH COLOR CORRECTED (K943045)Reliant Technologies, Inc.1994-12-13+ Add
LIHTAN 4100 KRYPTON (K942729)Lihtan Technologies, Inc.1994-12-13+ Add
CANDELA ELLIPTICAL SPOT HANDPIECE (K945587)Candela Laser Corp.1994-12-08+ Add
CANDELA Q-SWITCHED ALEXANDRITE LASER (K940173)Candela Laser Corp.1994-12-07+ Add
MEGABEAM LATERAL FIRE (K943527)Ceram Optec, Inc.1994-12-05+ Add
MEDICAL OPTICS CO2 SURGICAL LASER SYSTEMS (K943543)Medical Options, Inc.1994-12-02+ Add
KTP/532, KTP/YAG AND KTP/YAG XP (K931445)Laser Surgical Systems1994-12-02+ Add
ENDOCARE PROLASE I ADVANCED LASER DELIVERY SYSTEM (K945054)Cytocare, Inc.1994-11-28+ Add
LATERALASE, MODIFIED (K944204)Trimedyne, Inc.1994-11-28+ Add
ACUTOME 2000 COLOR-CORRECTED LAPAROSCOPIC C02 LASER COUPLER AND SLEEVES (K942868)Reliant Laser Corp.1994-11-14+ Add
MODEL 230-SAS LASER DELIVERY PROBE (K944630)Mnlase, Inc.1994-11-09+ Add
ECLIPSE 3200 (K944153)Cardiogenes1994-11-09+ Add
COAXIAL ENDOSTAT (K944977)Laserscope1994-11-08+ Add
LASERSONICS RADIANCE DIODE LASER SYSTEMS AND ACCESSORIES (K944346)Heraeus Surgical, Inc.1994-11-08+ Add
CANDELA H:ERB LASER (K921995)Candela Laser Corp.1994-11-07+ Add
MODEL 220-SC CURVED ENDOPHOTOCOAGULATOR LASER (K944627)Mnlase, Inc.1994-11-03+ Add
MODEL 220-SS LASER DELIVERY PROBE (K944628)Mnlase, Inc.1994-11-03+ Add
MODEL 230-SAC LASER DELIVERY PROBE (K944629)Mnlase, Inc.1994-11-03+ Add
MODEL 210-AS ASPIRATING ENDOPHOTOCOAGULATOR LASER (K944626)Mnlase, Inc.1994-11-03+ Add
STRAIGHT ENDOPHOTOCOAGULATOR LASER PROBE (K944471)Mnlase, Inc.1994-11-03+ Add
PARADERM -585M DERMATOLOGICAL LASER (K941559)Paradigm Lasers, Inc.1994-11-03+ Add
MODEL 210-AC ASPIRATING ENDOPHOTOCOAGULATOR LASER (K944625)Mnlase, Inc.1994-11-03+ Add
CURVED ENDOPHOTOCOAGULATOR LASER PROBE (K944470)Mnlase, Inc.1994-11-03+ Add
DENTAL LASER FIBER SYSTEM (K945143)Incisive Technologies, Inc.1994-11-01+ Add
MULTILITE ERBIUM:YAG SURGICAL LASER SYSTEM (K933057)Continuum Electro-Optics, Inc.1994-11-01+ Add
MODEL 130-SAC ASPIRATING ENDOPHOTOCOAGULATOR LASER (K944624)Mnlase, Inc.1994-11-01+ Add
CURVD ENDOPHOTOCOGULATOR LASER PROBE (K944472)Mnlase, Inc.1994-11-01+ Add
MODEL 110-AC ASPIRATING ENDOPHOTOCOAGULATOR LASER (K944621)Mnlase, Inc.1994-11-01+ Add
LASER DELIVERY PROBE (K944282)Mnlase, Inc.1994-11-01+ Add
MODEL 120-SC LASER DELIVERY PROBE (K944631)Mnlase, Inc.1994-11-01+ Add
MODEL 110-AS ASPIRATING ENDOPHOTOCOAGULATOR LASER (K944622)Mnlase, Inc.1994-11-01+ Add
MODEL 120-SS LASER DELIVERY PROBE (K944632)Mnlase, Inc.1994-11-01+ Add
MODEL 130-SAS ASPIRATING ENDOPHOTOCOAGULATOR LASER (K944623)Mnlase, Inc.1994-11-01+ Add
OPTICAL FIBER FOR ENT APPLICATIONS (K944151)Cardiogenes1994-11-01+ Add
GENESIS 2000 (K944206)Ion Laser Technology1994-10-11+ Add
GENESIS 2000 (K944317)Ion Laser Technology1994-10-11+ Add
THE HOOK-CURVED CLOSED END/ELECT FIBER LASER DELIV SYS (K944091)Lca, Inc.1994-10-07+ Add
CANDELA ALEX LAZR Q-SWITCHED ALEXANDRITE LASER (K944090)Candela Laser Corp.1994-09-30+ Add
GENEMED YAG 1000 MEDICAL LASER (K943479)Genemed, Inc.1994-09-29+ Add
CONBIO CUB-D10 COOPER LASER SYSTEM (K942934)Continuum Biomedical, Inc.1994-09-27+ Add
CROSSFIRE(TM) (705-10650) (K943171)Cardiogenes1994-09-20+ Add
KARL STORZ LASER ACCESSORIES (K942786)KARL STORZ Endoscopy-America, Inc.1994-09-16+ Add
FULL SPECTRUM ULE FIBER, MODEL FF101 (K920596)Gerald J. Shirk, M.D.1994-09-06+ Add
SLASE 210 PLUS HOLMIUM LASER SYSTEM (K942542)Sunrise Technologies, Inc.1994-09-01+ Add
PLTL-1 & PLDL-1 510NM PULSED DYE LASERS (K934811)Candela Laser Corp.1994-09-01+ Add
OPTICON(TM) CONNECTOR ADAPTER II (K942759)Xintec Corporation1994-08-31+ Add
LASER PHOTONICS ML755 DERMABLASER (K934501)Laser Photonics, Inc.1994-08-30+ Add
MEGABEAM LATERAL FIRE FIBER OPTIC DELIVERY SYSTEM (K943526)Ceram Optec, Inc.1994-08-26+ Add
SLT PRISM/REFRACTING PROBE (K934208)Surgical Laser Technologies, Inc.1994-08-26+ Add
MEGABEAM LATERAL FIRE (K943444)Ceram Optec, Inc.1994-08-26+ Add
MEGABEAM FIBER OPTIC DELIVERY SYSTEM (K943445)Ceram Optec, Inc.1994-08-26+ Add
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