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GEX

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

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RecordFirmDateBuilder
CYNOSURE PHOTOGENICA ER LASER (K973498)Cynosure, Inc.1997-11-13+ Add
PROTEGE ER:YAG LASER SYSTEM AND ACCESSORIES (K971912)Xintec Corporation1997-11-03+ Add
C4 (K970143)Clinicon Corp.1997-10-29+ Add
DERMA K LASER SYSTEM (K972872)Esc Medical Systems , Ltd.1997-10-28+ Add
LASETTE (K973431)Cell Robotics, Inc.1997-10-28+ Add
DERMASCAN SURGICAL LASER SCANNER (K972028)Esc Medical Systems , Ltd.1997-10-24+ Add
NUVOLASE 720 SYSTEM FOR OPHTHALMOLOGY LASER (K972765)American Laser Medical1997-10-21+ Add
NUVOLASE 660 LASER SYSTEM FOR OPHTHALMOLOGY (K972561)American Laser Medical1997-10-06+ Add
MM-RUBY (K970475)American Lasers, Inc.1997-09-29+ Add
UNICA 315 M CO2 SURGICAL LASER SYSTEM (K971821)Reliant Technologies, Inc.1997-09-25+ Add
FOTONA SKINLIGHT PLUS ND: YAG SYSTEM (K972368)Medical Laser Solutions1997-09-23+ Add
MODIFIED COHERENT VERSAPULSE AESTHETIC SURGICAL LASER (K972347)Lumenis, Inc.1997-09-19+ Add
PULSEMASTER 1000 ST DENTAL LASER SYSTEM (K972325)American Dental Technologies, Inc.1997-09-19+ Add
MEDLITE IV Q-SWITCHED, FREQUENCY DOUBLED, ND:YAG LASER (K970808)Continuum Biomedical, Inc.1997-09-05+ Add
SHARPLAN EPITOUCH RUBY LASER SYSTEM (K972099)Sharplan Lasers, Inc.1997-08-27+ Add
CYNOSURE DERMATOLOGY LASER COOLING TIP (K972002)Cynosure, Inc.1997-08-27+ Add
SCANNING DEVICE ACCESSORY FOR USE WITH THE CB DIODE/532 ND:YAG LASER (K971903)Continuum Biomedical, Inc.1997-08-21+ Add
SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000) (K971874)Sharplan Lasers, Inc.1997-08-18+ Add
SCANNING DEVICE ACCESSORY FOR USE WITH THE CB ERBIUM/2.94 ER:YAG LASER (K971879)Continuum Biomedical, Inc.1997-08-14+ Add
ACCU-PULSE CARBON DIOXIDE LASER SYSTEM (K971830)Argus Photonics Group1997-08-14+ Add
LASETTE (K965124)Cell Robotics, Inc.1997-08-14+ Add
CYNOSURE PHOTOGENICA LPIR DERMATOLOGICAL LASER (K971737)Cynosure, Inc.1997-08-08+ Add
SURESCAN (K964831)Clinicon Corp.1997-08-08+ Add
IMPROVEMENTS TO THE MEHL RUBY LASER (K971814)Mehl/Biophile Intl., Inc.1997-08-01+ Add
LASER PERIPHERALS HOLMIUM BARE FIBERS (K972272)Laser Peripherals, LLC1997-07-29+ Add
LASERSCOPE VELA ERBIUM:YAG LASER SYSTEM AND ACCESSORIES (K971843)Laserscope1997-07-23+ Add
SHARPLAN ERBIUM: YAG LASER (4020) (K971648)Sharplan Lasers, Inc.1997-07-23+ Add
SHARPLAN CO2 SURGICAL LASER SYSTEM (K971743)Sharplan Lasers, Inc.1997-07-18+ Add
DERMALASE (K971459)Endo Technic Corp.1997-07-18+ Add
CYNOSURE PHOTOGENICA VLV CUTANEOUS VASCULAR LESION LASER (K965128)Cynosure, Inc.1997-07-14+ Add
CELL ROBOTICS ER: YAG SURGICAL LASER (K970461)Cell Robotics, Inc.1997-07-11+ Add
SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940/ERBIUM CRYSTALASE (FORMERLY TRILASE 2940 ERBIUM LASER (K971404)Schwartz Electro-Optics, Inc.1997-07-09+ Add
EPILIGHT HAIR REMOVAL SYSTEM (K963249)Esc Medical Systems , Ltd.1997-07-07+ Add
LASERSCOPE MICROBEAM IV MICROMANIPULATOR (K971250)Laserscope1997-06-30+ Add
LASEAWAY LONG PULSE AND Q-SWITCHED RUBY LASER SYSTEM (K971193)Polytec Pi, Inc.1997-06-24+ Add
DENTICA PULSED ND: YAG LASER SYSTEMS AND ACCESSORIES (K971065)Xintec Corporation1997-06-17+ Add
ORION SERIES SURGICAL LASER SYSTEM (Q-SWITCHED ND:YAG CONFIGURATION) (K964818)Laserscope1997-06-17+ Add
SOFTSCAN (K971024)Sahar Technologies, Inc.1997-06-17+ Add
CB ERBIUM/2.94(TM) ER:YAG LASER (K970934)Continuum Biomedical, Inc.1997-06-11+ Add
STRAIGHTFIRE REUSABLE OPTICAL FIBERS (400,600,800,1000) (K965180)Myriad Lase, Inc.1997-06-05+ Add
CYNOSURE DLS-10-810 DIODE LASER GENERAL PHOTOCOAGULATOR (K970243)Cynosure, Inc.1997-06-03+ Add
NOVATIP FAMILY OF LASER HANDPIECE TIPS (K971539)Xanova Corp.1997-06-03+ Add
TRU-PULSE CO2 SURGICAL LASER (K970804)Tissue Technologies, Inc.1997-06-03+ Add
800 SERIES SURGICAL LASER SYSTEM AND ACCCESSORIES (K970948)Laserscope1997-05-21+ Add
NUVO-LASE 660 LASER SYSTEM (K970667)American Laser Medical1997-05-13+ Add
MEDLITE ND:YAG LASER SYSTEM: NEW DYE ACCESSORY HANDPIECE (K963340)Continuum Biomedical, Inc.1997-05-12+ Add
FOTONA SKINSCAN (K970757)Medical Laser Solutions1997-05-09+ Add
CENTAURI (K932683)Premier Laser Systems, Inc.1997-05-05+ Add
CENTAURI (K933841)Premier Laser Systems, Inc.1997-05-05+ Add
FSI LAPAROSCOPIC PROBE FOR ALL FSI ULE-OVERCLAD FF201 FIBERS (K963991)Full Spectrum, Inc.1997-04-24+ Add
(FSI) LAPAROSCOPIC PROBE FOR ALL FSI ULE FF101 FIBERS. MODEL FSI FF101-LP-XXX, WHERE XXX = FIBER DIAMETERS 100, 200, 400 (K963996)Full Spectrum, Inc.1997-04-24+ Add
RIGHT ANGLE LASER FIBERS;OPTILASE ND:YAG LASER;OPTILASE PL100 ND LASER SYSTEMS (K970422)Trimedyne, Inc.1997-04-21+ Add
RESPOSABLE OMNI TIP(TM) SWITCHABLE TIPS (MULTIPLE) (K964585)Trimedyne, Inc.1997-04-17+ Add
VENISECT LASER LANCET (K955653)Venisect, Inc.1997-04-11+ Add
DERMA 20 LASER SYSTEM (K964253)Esc Medical Systems , Ltd.1997-04-11+ Add
LASERSCOPE AUTOMATIC EYE PROTECTION FILTER (K970157)Laserscope1997-04-07+ Add
ACCUCURE 1000 (K970637)Lasermed, Inc.1997-04-02+ Add
DIOLITE 532 (K964074)Iriderm Div.1997-04-01+ Add
NIDEK CYBERSCAN (K970017)Nidek, Inc.1997-03-18+ Add
LASER EYE GOGGLES (K970361)Stefanovsky & Assoc.1997-03-18+ Add
MCL 29 DERMABLATE ERBIUM LASER SYSTEM (K964128)Aesculap-Meditec GmbH1997-03-17+ Add
CPC PROBE (K961380)Carl Zeiss, Inc.1997-03-17+ Add
TOPAZ 30 SURGICAL LASER SYSTEM (K965015)Esc Medical Systems, Inc.1997-03-14+ Add
SLS CHROMOS 694 QD RUBY LASER TO BE RENAMED MEHL QD RUBY LASER SYSTEM FOR HAIR REMOVAL (K962109)Classy Lady by Mehl of Puerto Rico, Inc.1997-03-13+ Add
NEW STAR MODEL 130 6-WATT ND: YAG LASER SYSTEM (K962791)New Star Lasers, Inc.1997-03-13+ Add
PULSEMASTER (K961269)American Dental Technologies, Inc.1997-03-10+ Add
SHARPLAN RUBY LASER SYSTEM (K962446)Sharplan Lasers, Inc.1997-03-07+ Add
EPILASER NORMAL MODE RUBY LASER (K963947)Spectrum Medical Technologies, Inc.1997-03-05+ Add
CYBERLASE CO2 LASER SYSTEM (K964353)Nidek, Inc.1997-02-28+ Add
INDIGO MEDICAL MODEL IDL 830 & MODEL IDL 830E LASER SYSTEMS FOR GENERAL GYNECOLOGICAL APPLICATIONS (K963081)Indigo Medical, Inc.1997-02-21+ Add
DORNIER MEDILAS FIBER TOME LASER (K964760)Dornier Medtech America, Inc.1997-02-19+ Add
ACCUCURE 3000 (K964486)Lasermed, Inc.1997-02-18+ Add
SOFTOUCH (K964684)Sahar Technologies, Inc.1997-02-14+ Add
TRU-PULSE LASER (MODIFIED) (K963683)Tissue Technologies, Inc.1997-02-12+ Add
PARASCAN SCANNING DEVICE (K964520)Laserscope1997-02-10+ Add
CERALAS DIODE LASER SYSTEM (CERALAS D15) (K964497)Ceram Optec, Inc.1997-02-06+ Add
ECLIPSE 2000 (K961560)Cardiogenes1997-01-27+ Add
COHERENT ULTRAPULSE CO2 SURGICAL LASERS (K963339)Coherent Medical Group1997-01-22+ Add
OMNIPULSE/OMNIPULSE-MAX (K962632)Trimedyne, Inc.1997-01-16+ Add
FOTONA SKINLIGHT LASER SYSTEM (K962902)Medical Laser Solutions1997-01-10+ Add
LIGHTSTIC MODEL 360 (K962965)Rare Earth Medical, Inc.1997-01-09+ Add
LASERSCOPE ERBIUM; YAG LASER SYSTEM AND ACCESSORIES (K964076)Laserscope1997-01-08+ Add
DCL8 ENHANCED PULSED ND:YAG LASER SYSTEM (K964031)Slt-J , Ltd.1996-12-23+ Add
CYNOSURE PHOTOGENICA LP DERMATOLOGICAL VASCULAR LESION LASER (K963094)Cynosure, Inc.1996-12-16+ Add
DAVOL PLUME FILTER (5541420) (K964211)Davol Inc., Sub. C. R. Bard, Inc.1996-12-02+ Add
FLEX-LASE 600 SERIES ION LASER SYSTEM (K963389)American Laser Medical1996-11-26+ Add
ACCU-BEAM LASER BLOCK 301513BG385/BEAM SPLITTERS 301513BG39 (K963193)Transamerican Technologies Intl.1996-11-13+ Add
PC LASER WITH SMART PLUG (PC EDO & DENTAL 200) (K963124)Fisma, Inc.1996-11-08+ Add
LIGHTSTIC MODEL 180 (K962068)Rare Earth Medical, Inc.1996-11-08+ Add
SHARPLAN MODELS 20C, 30C, AND 40C CO2 LASERS (K963229)Sharplan Lasers, Inc.1996-11-05+ Add
AOC MEDICAL SYSTEM MODEL PHASE II 50 SURGICAL DIODE LASER SYSTEM (K961705)Applied Optronics Corp.1996-11-01+ Add
SHARPLAN LASERS, INC. SILKTOUCH CO2 FLASH SCANNER (K961935)Sharplan Lasers, Inc.1996-11-01+ Add
AOC MEDICAL SYSTEM MODEL PHASE II 25 SURGICAL DIODE LASER SYSTEM (K961710)Applied Optronics Corp.1996-11-01+ Add
CYNOSURE PHOTOAPPEAL CO2 SURGICAL LASERS (K962993)Cynosure, Inc.1996-10-31+ Add
CERALAS G ND;YAG LASER SYSTEM (CERALAS G) (K962948)Ceram Optec, Inc.1996-10-25+ Add
OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR, OR EQUIVALENT LASER SYSTEMS (K962592)Alcon Laboratories1996-09-23+ Add
MEDLITE/755 ALEXANDRITE LASER SYSTEM (K961006)Continuum Biomedical, Inc.1996-09-11+ Add
PHOTODERM PL. (K960772)Esc Medical Systems , Ltd.1996-09-11+ Add
DIOMED 15, 30, 60 SURGICAL DIODE LASER (K962354)Lifestream Int'L, Inc.1996-09-11+ Add
SURESCAN (K962242)Clinicon Corp.1996-09-03+ Add
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