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GEX

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

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RecordFirmDateBuilder
SHARPLAN LASERS, INC. AF ACUSPOT MICROMANIPULATOR (713) (K962974)Sharplan Lasers, Inc.1996-08-21+ Add
LASERSONICS ND:YAG CYLINDRICALLY DIFFUSING STERILE DISPOSABLE FIBER (K960636)Heraeus Surgical, Inc.1996-08-21+ Add
ARGON CURING LASER (K961682)Premier Laser Systems, Inc.1996-08-15+ Add
MEDLITE/ERBIUM LASER SYSTEM (K961748)Continuum Biomedical, Inc.1996-07-26+ Add
RD-1200H NORMAL MODE RUBY LASER SYSTEM (K955612)Spectrum Medical Technologies, Inc.1996-07-09+ Add
LASER PERIPHERALS INC. BARE FIBER (K961516)Laser Peripherals, LLC1996-06-27+ Add
SHARPLAN LASERS, INC. RUBY LASER SYSTEM (K961279)Sharplan Lasers, Inc.1996-06-18+ Add
CANDELA Q-SWITCHED ALEXANDRITE LASERS (K955662)Candela Laser Corp.1996-06-14+ Add
DCL8 ENHANCED PULSED ND:YAG LASER SYSTEM (K960086)Slt-J , Ltd.1996-06-03+ Add
PULSEMASTER (K961136)American Dental Technologies, Inc.1996-06-03+ Add
SDL DIODE LASER SYSTEM (K960905)Slt-J , Ltd.1996-06-03+ Add
LASER PERIPHERALS INC. SCATTERFREE FIBER (K961079)Laser Peripherals, LLC1996-05-22+ Add
SLT FUMICH PROBE GUIDE (K960821)Surgical Laser Technologies, Inc.1996-05-16+ Add
FREQUENCY DOUBLED ND:YAG PHOTOCOAGULATOR(VIRIDIS) FREQUENCY DOUBLED ND:YAG PHOTOCOAGULATOR(EVERGREEN 532) (K960867)B.V. Intl. S.A.1996-05-14+ Add
LASER FIBER DELIVERY/CLEANING CATHETER (K960768)Cook Urological, Inc.1996-05-14+ Add
SHARPLAN LASERS, INC. SILKTOUCH XJ SCANNER (K960820)Sharplan Lasers, Inc.1996-05-10+ Add
SHARPLAN LASERS, INC. SILKTOUCH FLASH SCANNER (K960521)Sharplan Lasers, Inc.1996-04-26+ Add
MODIFIED LUXAR LX-20 FAMILY CO2 LASER SYSTEM (K960475)Luxar Corp.1996-04-26+ Add
CYNOSURE PHOTOGENICA VL CUTANEOUS VASCULAR LESION LASER (K960579)Cynosure, Inc.1996-04-23+ Add
COHERENT SLIMLINE SINGLE LUMEN ASPIRATION NEEDLE KIT (K960413)Lumenis, Inc.1996-04-04+ Add
COHERENT VERSAPULSE AESTHETIC SURGICAL LASERS (K960032)Coherent Medical Group1996-04-01+ Add
CB DIODE/532 LASER SYSTEM (K954905)Continuum Biomedical, Inc.1996-03-29+ Add
PROTEGE ER:YAG SURGICAL LASER SYSTEM AND ACCESSORIES (K951876)Xintec Corporation1996-03-25+ Add
PRODIGY SUPERPULSE ND:YAG SURGICAL LASER SYSTEMS & ACCESSORIES (K951935)Xintec Corporation1996-03-25+ Add
RIGHT ANGLE LASER FIBERS (K954597)Trimedyne, Inc.1996-03-11+ Add
FULL SPECTRUM ULE-OVERCLAD FIBER: MODEL 201 (K955862)Full Spectrum, Inc.1996-03-01+ Add
SHARPLAN LASERS, INC SILKTOUCH 2 FLASH SCANNER (K955621)Sharplan Lasers, Inc.1996-02-27+ Add
MEDLITE LASER SYSTEM (K955131)Continuum Biomedical, Inc.1996-02-20+ Add
INDIGO MEDICAL MODEL IDL 830E (K955758)Indigo Medical, Inc.1996-02-16+ Add
CERALAS F ND:YAG LASER SYSTEM (K953851)Ceram Optec, Inc.1996-02-16+ Add
LASERSONICS PARASCAN DOSIMETER DEVICE (K955734)Heraeus Surgical, Inc.1996-02-13+ Add
SCHWARTZ ELECTRO-OPTICES, INC. TRILASE 2100/20 HOLMIUM LASER (K953585)Schwartz Electro-Optics, Inc.1996-02-05+ Add
SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM (MODIFICATION) (K954727)Surgical Laser Technologies, Inc.1996-02-05+ Add
CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASE (K954934)Candela Laser Corp.1996-02-02+ Add
TRILASE 2940 ERBIUM LASER (K954013)Schwartz Electro-Optics, Inc.1996-01-31+ Add
APPLIED OPTRONICS MODEL AOC 5060 SURGFICAL DIODE LASER SYSTEM (K955007)Applied Optronics Corp.1996-01-26+ Add
APPLIED OPTRONICS MODEL AOC 25 SURGICAL DIODE (K955014)Applied Optronics Corp.1996-01-26+ Add
MICROQUARTZ MEDICAL TYPE B SIDE-FIRING LASER FIBER (K955861)Microquartz Medical, Inc.1996-01-26+ Add
ACCUSCAN MODEL C CO2 LASER SCANNER (K953670)Reliant Technologies, Inc.1996-01-26+ Add
INDIGO PORTABLE LASER SYSTEM, INDDIGO FIBEROPTICS (K954195)Indigo Medical, Inc.1996-01-25+ Add
OMEGA ULTRASCAN (K954911)Gyne-Tech Instrument Corp.1996-01-24+ Add
MICROQUARTZ MEDICAL GENERAL SHAPE LASER FIBER (K954904)Microquartz Medical, Inc.1996-01-22+ Add
6 WATT HOLMIUM LASER SYSTEM (K952489)New Star Lasers, Inc.1996-01-22+ Add
ECLIPSE 2100 (K955006)Cardiogenes1996-01-17+ Add
CERALAS G FREQUENCY DOUBLED ND;YAG LASER SYSTEM (K954834)Ceram Optec, Inc.1996-01-17+ Add
ODYSSEY HO:YAG SURGICAL LASER SYSTEMS & ACCESSORIES (K951910)Xintec Corporation1995-12-27+ Add
NEO-MED DLS-1100 (K954931)Neo-Laboratories, LLC1995-12-18+ Add
ILT SURGICAL LASER (K954460)Ion Laser Technology1995-12-18+ Add
AURORA SURGICAL DIODE LASER SYSTEM W/ACCESSORIES (K954316)Premier Laser Systems, Inc.1995-12-15+ Add
OPTILITE VIII LASER SURGERY ACCESSORIES (K951760)Xintec Corporation1995-11-29+ Add
AM RUBY (K950826)American Lasers, Inc.1995-11-29+ Add
MLT 20 (K953800)Medical Laser Technology, Inc.1995-11-29+ Add
SHARPLAN MODEL 2040 PULSED CTH:YAG SURGICAL LASER SYSTEM (K952277)Sharplan Lasers, Inc.1995-11-16+ Add
LOKKI DT (K952682)Lokki1995-11-14+ Add
SHARPLAN LASERS, INC. SURGICAL DIODE LASER (K953794)Sharplan Lasers, Inc.1995-11-14+ Add
LASER GAS MIXTURE (K954544)Liquid Technology Corp.1995-10-30+ Add
LASESONICS LOW POWER CO2 LASER SYSTEM (K953917)Heraeus Surgical, Inc.1995-10-26+ Add
CANDELA MODEL PLTL-1 LASER SYSTEM (K953412)Candela Laser Corp.1995-10-24+ Add
LIHTAN 532 LASER (K951117)Buckman Co., Inc.1995-10-18+ Add
SLT THERMALITE DIODE LASER SERIES, DIODE 980, 810, 940 (K952661)Surgical Laser Technologies, Inc.1995-10-06+ Add
LMT 20 AA LASER SURGICAL SYSTEM (K952046)Laser Max Medical Technologies Corp.1995-10-03+ Add
LMT 40 AA LASER SURGICAL SYSTEM (K952047)Laser Max Medical Technologies Corp.1995-10-03+ Add
LMT 20 HH LASER SURGIVAL SYSTEM (K952045)Laser Max Medical Technologies Corp.1995-10-03+ Add
DORNIER THERMAFOCUS 360 FIBER (K950996)Daimler-Benz Aerospace1995-10-03+ Add
ULTRABRIGHT (MICROQUARTZ MEDICAL SIDE-FIRING LASER FIBER) (K953065)Microquartz Medical, Inc.1995-09-27+ Add
ADVANCED LASER MULTILINE SYSTEM, ALY (K952796)Advanced Laser Services Corp.1995-09-18+ Add
TAPERTIP MULTISUE HOLMIUM ARTHROSCOPIC HANDPIECE, VARIOUS ENDFIRING MODELS, WITH/OUT A STERILIZABLE INSTRUMENT TRAY (K953494)Trimedyne, Inc.1995-09-14+ Add
POWERSCULPTOR PROBES (K952755)Cardiogenes1995-09-14+ Add
MED-TECH LASER GAS MIXTURE (K953933)Medical Technical Gases Inc..1995-09-01+ Add
MODIFIED LUXAR LX-20 FAMILY CO2 LASER SYSTEM (K953074)Luxar Corp.1995-08-28+ Add
QUADRALASE (MICROQUARTZ MEDICAL ADJUSTABLE SIDE-FIRING LASER FIBER) (K952974)Microquartz Medical, Inc.1995-08-28+ Add
MICROQUATZ MEDICAL LINEAR MODULATOR ACCESSORY (K953174)Microquartz Medical, Inc.1995-08-28+ Add
AM-YAG (K950825)American Lasers, Inc.1995-08-28+ Add
SCHWARTZ ELECTRO-OPTICS, INC. TRILASE LASER SYSTEM (K952554)Schwartz Electro-Optics, Inc.1995-08-28+ Add
CORSSFIRE PLUS (K953658)Cardiogenes1995-08-21+ Add
SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM & WCE DIFFUSER FLAT PROBE DF 2 (K952216)Surgical Laser Technologies, Inc.1995-08-18+ Add
CYNOSURE PHOTOGENICA T10 TATTOO REMOVAL LASER (K950684)Cynosure, Inc.1995-08-16+ Add
SMART PLUG (K950120)Hgm, Inc.1995-08-11+ Add
ECLIPSE 3200 (K953424)Cardiogenes1995-08-11+ Add
ELMER (K952118)Biological Technology Corp.1995-08-07+ Add
PHOTODERM VL. (K950493)Esc, Energy Systems Corp.1995-08-07+ Add
SACS, INDEPENDENT FIBER COOLANT SYSTEM (K952754)Surgical Laser Technologies, Inc.1995-07-31+ Add
MEDLITE LASER SYSTEM (K952636)Continuum Biomedical, Inc.1995-07-31+ Add
SIDEFIRE - TIPPED REUSABLE OPTICAL FIBERS (K952733)Myriad Lase, Inc.1995-07-31+ Add
TRU-PULSE PULSED CO2 SURGICAL LASER SYSTEM (K952049)Tissue Technologies, Inc.1995-07-21+ Add
OMNIPULSE-MAX HOLMIUM LASER (K951562)Trimedyne, Inc.1995-07-21+ Add
SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM (K952813)Surgical Laser Technologies, Inc.1995-07-20+ Add
SURGISCAN SCANNER (K952299)Norcross Scientific1995-07-17+ Add
MEGABEAM ENDO-ENT PROBE (K952772)Ceram Optec, Inc.1995-07-17+ Add
CERALAS DIODE LASER SYSTEM (MODEL CERALAS D50) (K951775)Ceram Optec, Inc.1995-07-17+ Add
CABOT MEDICAL-SURGITEK ULTRAGOLD PLUS SIDE-FIRING UROLOGIC LASER FIBER (K951714)Cabot Medical Corp.1995-07-11+ Add
MODIFIED COHERENT ULTRAPULSE CO2 SURGICAL LASERS (K951812)Lumenis, Inc.1995-07-07+ Add
GX-PAN PANORAMIC DENTAL X-RAY SYSTEM (K952598)Gendex Corp.1995-06-29+ Add
ACUTOME(R) 150 MULTI-WAVELENGTH COLOR-CORRECTED(TM) LASER HANDPIECE (K950215)Reliant Laser Corp.1995-06-15+ Add
SHARPLAN MODEL 3100 ND:YAG SURGICAL LASER SYSTEM (K951165)Sharplan Lasers, Inc.1995-06-12+ Add
MEGABEAM ASPIRATING ENDOCULAR PROBE (K952340)Ceram Optec, Inc.1995-06-12+ Add
MODEL 550-DC CROSSFIRE(TM) (K945564)Eclipse, Inc.1995-06-01+ Add
LASER GAS MIXTURE (K952301)Airgas Management, Inc.1995-06-01+ Add
SHARPLAN MODEL 712 ACUSPOT MICROMANIPULATOR (K951204)Sharplan Lasers, Inc.1995-06-01+ Add
MEDICAL MIXTURE-LASER GAS MIXTURES (K952162)Standard Welders Supply Co.1995-06-01+ Add
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