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GEX

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

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RecordFirmDateBuilder
DIODE LASER (K982119)Esc Medical Systems , Ltd.1999-02-04+ Add
CERALAS DIODE LASER SYSTEM (MODEL H) (K983950)Ceram Optec, Inc.1999-02-03+ Add
OPMI TWINER SURGICAL MICROSCOPE (K983868)Carl Zeiss, Inc.1999-01-29+ Add
KAVO KEY LASER 1242 (K983100)Kavo America1999-01-27+ Add
CYNOSURE ERASURE LASER (K984517)Cynosure, Inc.1999-01-20+ Add
LASETTE (K983673)Cell Robotics, Inc.1999-01-15+ Add
CYBER-LASE 2000 CURING AND WHITENING LASER (K983654)Ics of North America, Inc.1999-01-12+ Add
LIGHT AGE EPICARE ALEXANDRITE LASER (K983977)Light Age, Inc.1999-01-07+ Add
CO2 LASER COUPLER (K983965)L.A.S.E.R., Inc.1998-12-22+ Add
LASERSCOPE COOLSPOT (K984110)Laserscope1998-12-18+ Add
UNIPULSE CO2 SURGICAL LASER SYSTEM (K980475)Nidek, Inc.1998-12-16+ Add
LASEAWAY ALEXANDRITE LASER SYSTEM (K982316)Silver Creek, Inc.1998-12-16+ Add
ACCU-PULSE 1000 CO2 SURGICAL LASER SYSTEM (K983543)Argus Photonics Group1998-12-16+ Add
SURECAUT DIAMOND LASER KNIFE (K983463)Clinicon Corp.1998-12-11+ Add
CELL ROBOTICS' LASETTE (K981746)Cell Robotics, Inc.1998-12-07+ Add
MULTIPULSE CO2 LASER (K983215)Aesculap-Meditec GmbH1998-12-04+ Add
COMPACT KTP LASER (K983020)Cosmos Medical Technology1998-11-25+ Add
DORNIER MEDILA H (K983963)Dornier Medtech America, Inc.1998-11-25+ Add
AURORA (K981379)Premier Laser Systems, Inc.1998-11-23+ Add
CERALAS D LASER SYSTEM, MODEL # CERALAS D15 (K983058)Ceram Optec, Inc.1998-10-21+ Add
MLT 30 LASER (K982548)Medical Laser Technologies , Ltd.1998-10-19+ Add
CENTAURI (K983211)Premier Laser Systems, Inc.1998-10-09+ Add
UMECO OPTIMA 694 RUBY LASER SYSTEM (K982113)Umeco, Inc.1998-09-30+ Add
LASETTE LASER SKIN PERFORATOR (K982230)Cell Robotics, Inc.1998-09-24+ Add
KAPLAN PENDULASER 115 SURGICAL LASER WITH OPTOSCAN II (K980398)Optomedic Medical Technologies , Ltd.1998-09-22+ Add
DORNIER MEDILAS D (K982629)Dornier Surgical Products, Inc.1998-09-14+ Add
DILKES LASER/SUCTION CANNULAE (K981143)Exmoor Plastics , Ltd.1998-09-14+ Add
DERMA K ER:YAG/CO2 LASER (K982827)Esc Medical Systems, Inc.1998-09-14+ Add
CYNOSURE CO3 ER:YAG LASER (K983034)Cynosure, Inc.1998-09-10+ Add
OCULIGHT GL WITH THE DERMATOLOGY HANDPIECE (K982031)Iridex Corp1998-09-08+ Add
COMBINATION ND:YAG AND FREQUENCY DOUBLED SOLID STATE GREEN LASER (K981952)Instruments For Medicine and Diagnostics1998-09-01+ Add
PEGASUS ND:YAG LASER SYSTEM (K980559)Premier Laser Systems, Inc.1998-08-24+ Add
NIDEK LIGHTSCAN (K982295)Nidek, Inc.1998-08-06+ Add
PROTEGE II ER: YAG LASER SYSTEM AND ACCESSOIES (UPGRADE) (K981627)Xintec Corporation1998-07-31+ Add
MEGABEAM REUSABLE FIBER OPTIC HANDPIECE AND NEEDLES (K980389)Ceram Optec, Inc.1998-07-29+ Add
EPILASER NORMAL MODE RUBY LASER (K980517)Palomar Medical Products, Inc.1998-07-21+ Add
DORNIER MEDILAS E (K981438)Dornier Surgical Products, Inc.1998-07-20+ Add
DUAL HOOK FIBEROPTIC DELIVERY SYSTEM (K970069)Ihd, Inc.1998-07-17+ Add
DORNIER MEDILAS H (K981718)Dornier Surgical Products, Inc.1998-07-17+ Add
800 SERIES SURGICAL LASER SYSTEM ORION SERIES SURGICAL LASER SYSTEM ANGLED DELIVERY DEVICES (K972575)Laserscope1998-07-17+ Add
AURORA DIODE LASER SYSTEM (K974586)Premier Laser Systems, Inc.1998-07-15+ Add
CANDELA GENTLELASE GL DERMATOLOGICAL LASER (K981351)Candela Corp.1998-07-13+ Add
ALEXIS ALEXANDRITE LASER SYSTEM AND ACCESSORIES (K981350)Xintec Corporation1998-07-09+ Add
LASER LANCET LB100 (K980538)Transmedica Intl., Inc.1998-07-09+ Add
SKINTONER SYSTEM (K980501)Fuller Research Corp.1998-07-08+ Add
LASETTE LASER SKIN PERFORATOR (K981149)Cell Robotics, Inc.1998-06-29+ Add
CHROMOSCAN SCANNING SYSTEM (K980753)Mehl/Biophile Intl., Inc.1998-06-29+ Add
CERALAS G FREQUENCY DOUBLED ND: YAG LASER SYSTEMS, CERALAS G3 (K981126)Ceram Optec, Inc.1998-06-25+ Add
FUTURELASE 3000/3002 ERBIUM LASER SYSTEM (K974641)Buckman Co., Inc.1998-06-08+ Add
DIO-LIGHT 60 LASER SYSTEM (K981447)Nidek, Inc.1998-06-05+ Add
REUSABLE MEGABEAM FIBER OPTIC DELIVERY SYSTEM (K980838)Ceram Optec, Inc.1998-06-02+ Add
SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 755 DP ALEXANDRITE LASER SYSTEM (K980710)Schwartz Electro-Optics, Inc.1998-05-22+ Add
PHOTODERM HR SYSTEM (K974536)Esc Medical Systems , Ltd.1998-05-20+ Add
MODIFIED VERSAPULSE SELECT HO:YAG AND HO:YAG/ND:YAG LASERS (K980685)Lumenis, Inc.1998-05-20+ Add
SOFTLIGHT Q-SWITCHED (ND:YAG) LASER (K971207)Thermolase Corp.1998-05-13+ Add
NIDEK PRIMA MODEL GYC-1500/2000 (K980547)Nidek, Inc.1998-05-13+ Add
LIGHTSHEER (K980420)Palomar Medical Products, Inc.1998-05-04+ Add
SURETOUCH (K980784)Sahar Technologies, Inc.1998-04-29+ Add
CYNOSURE PHOTOLIGHT FLASHLAMP SYSTEM (K974674)Cynosure, Inc.1998-04-29+ Add
LASERLITE DIODE SURGICAL LASER (K981090)Laserlite, LLC1998-04-21+ Add
SLT CL MD CONTACT LASER SYSTEM (K972548)Surgical Laser Technologies, Inc.1998-04-21+ Add
DERMABLATE ER: YAG LASER SYSTEM (K980361)Aesculap-Meditec North America1998-04-21+ Add
DENTEK LD 15 LASERSYSTEM (K974057)Dentek Lasersystems Produktions Ges.M.B.H.1998-04-21+ Add
ND: YAG ACCESSORY FOR PHOTODERM SYSTEM (K980537)Esc Medical Systems , Ltd.1998-04-15+ Add
MLT R694 RUBY LASER SYSTEM (K980187)Medical Laser Technologies , Ltd.1998-04-03+ Add
FEATHERLITE DIODE LASER (K980142)Laserlite, LLC1998-04-03+ Add
E3 MICROPROBE (K974878)Martin Uram, MD1998-03-27+ Add
FOTONA SKINPLUS LASER SYSTEM (K980560)Fotona D.D.1998-03-27+ Add
LASERSCOPE EL LASER SYSTEM AND ACCESSORIES (K974896)Laserscope1998-03-27+ Add
SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASE (K980313)Schwartz Electro-Optics, Inc.1998-03-19+ Add
DERMIUM (K980561)Premier Laser Systems, Inc.1998-03-19+ Add
JENASCAN (K980001)Jenoptik Laser, Optik, Systeme GmbH1998-03-19+ Add
NIDEK MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-7000 (K974732)Nidek, Inc.1998-03-18+ Add
DIO-LIGHT LASER SYSTEM (K980201)Nidek, Inc.1998-03-16+ Add
EPILASER I UPGRADE KIT (K980160)Palomar Medical Products, Inc.1998-03-10+ Add
COHERENT ULTRAPULSE S SERIES CO2 SURGICAL LASERS MODEL C AND L (K974789)Lumenis, Inc.1998-03-09+ Add
SLT SELECT FIBER DELIVERY SYSTEM AND CONTACT TIPS (K980156)Surgical Laser Technologies, Inc.1998-02-27+ Add
CYNOSURE PHOTOGENICA 532 LASER (K974900)Cynosure, Inc.1998-02-27+ Add
ALEX TA2 ERASER (K980131)Light Age, Inc.1998-02-17+ Add
CANDELA GENTLELASE GL DERMATOLOGICAL LASER (K974381)Candela Corp.1998-02-10+ Add
SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 755 LASER SYSTEM (K973867)Schwartz Electro-Optics, Inc.1998-02-10+ Add
LS-905 FIBERCHOICE ADAPTER SYSTEM (K974229)Laser Peripherals, LLC1998-02-10+ Add
RESPOSABLE BARE FIBERS (K973172)Trimedyne, Inc.1998-02-03+ Add
HM-RUBY (K974142)American Lasers, Inc.1998-01-28+ Add
LITE TOUCH ERBIUM LASER TREATMENT SYSTEM (K974460)Lorad Corp.1998-01-16+ Add
STARLIGHT PULSED DIODE ARRAY LASER SYSTEM (K974346)Star Medical Technologies, Inc.1998-01-16+ Add
SCANTECH LASER SCANNER (K974633)Phantom Technologies, Inc.1998-01-16+ Add
SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASE (K974039)Schwartz Electro-Optics, Inc.1998-01-12+ Add
PRIMA KTP LASER SYSTEM (K973828)Nidek, Inc.1998-01-05+ Add
TEMPERATURE DIAGNOSTIC ACCESSORY (K973764)New Star Lasers, Inc.1997-12-31+ Add
INDIGO PORTABLE LASER SYSTEM WITH TEMPERATURE FEEDBACK -MODEL IDL 830 (POWER OPTIONS : 25, 20, 15 & 10 WATTS) INDIGO FIB (K963969)Indigo Medical, Inc.1997-12-23+ Add
MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND:YAG LASER (K973719)Continuum Biomedical, Inc.1997-12-23+ Add
SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 1064/532 LASER SYSTEM (K973603)Schwartz Electro-Optics, Inc.1997-12-19+ Add
ERBIUM 2000 LASER FAMILY (K972915)Phantom Technologies, Inc.1997-12-19+ Add
ARAGO (K971118)Premier Laser Systems, Inc.1997-12-16+ Add
COHERENT POPEYE OPHTHALMIC LASER SYSTEM, COHERENT POPEYE OPHTHALMIC LASER SYSTEM IN COMBINATION WITH THE COHERENT ARGONS (K973470)Lumenis, Inc.1997-12-09+ Add
EPULSE MODEL 2940 ER:ASER ER:YAG LASER SYSTEM (K973576)Epulse Technologies, Inc.1997-12-09+ Add
SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000) (K973354)Sharplan Lasers, Inc.1997-12-04+ Add
CANDELA GENTLELASE GL DERMATOLOGICAL VASCULAR LESION LASER (K972767)Candela Corp.1997-12-04+ Add
STARLIGHT PULSED DIODE ARRAY LASER SYSTEM (K973324)Star Medical Technologies, Inc.1997-12-03+ Add
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