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GEX

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

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RecordFirmDateBuilder
SURGICAL CARBON DIOXIDE LASER SYST MODEL 20-CH (K904930)Directed Energy, Inc.1991-03-21+ Add
OPTILASE (TM) MODEL 900 ARGON (K903838)Trimedyne, Inc.1991-03-05+ Add
CODMAN NEUROLASE LASER SYSTEM/MODIFICATION (K905511)I.L. Med, Inc.1991-03-05+ Add
KTP DISC KIT (K905424)Laserscope1991-03-04+ Add
SURGILASE SL 150 SURGICAL LASER SYSTEM (K905006)Surgilase, Inc.1991-02-21+ Add
LASERMATIC SUPERCOMBO(TM) SURGICAL LASER SYSTEM (K903131)Lasermatic, Inc.1991-02-19+ Add
ENDOCOAGULATOR KRS568(TM) LASER (K904700)Hgm Medical Laser Systems, Inc.1991-02-19+ Add
AUTODERM SCANNER CONTROL CONSOLE (K904266)Charles I. Rose & Co., Inc.1991-02-19+ Add
ALTAIR (K905072)Pfizer Laser Systems1991-02-07+ Add
NIDEK DC-3000 DIODE LASER PHOTOCOAGULATOR (K903639)Nidek, Inc.1991-02-04+ Add
PEGASUS WITH ACCESSORIES (K905082)Pfizer Laser Systems1991-01-31+ Add
DISPOSABLE FIBER OPTIC DELIVERY SYSTEM (K904911)Fiber Delivery Concepts, Inc.1991-01-25+ Add
ILLUMINA MODEL 780 CO2 LASER SYSTEM (K905637)Heraeus Lasersonics, Inc.1991-01-18+ Add
MOOR LASER BLOOD FLOW MONITOR MBF3 (K905232)Moor Instruments, Ltd.1991-01-11+ Add
MOOR LASER BLOOD FLOW MONITOR MBF3D (K905233)Moor Instruments, Ltd.1991-01-11+ Add
CENTAURI YAG LASER SYST, EAR, NOSE , THROAT (K904627)Pfizer Laser Systems1991-01-07+ Add
CENTAURI YAG LASER SYST, UROLOGY (K904629)Pfizer Laser Systems1991-01-07+ Add
CENTAURI YAG LASER SYST, GASTROENTEROLOGY (K904628)Pfizer Laser Systems1991-01-07+ Add
LPI MULILASE YAG/532 SURGICAL LASER SYSTEM (K904354)Laser Photonics, Inc.1990-12-19+ Add
SERIES 1990 ARGON SURGICAL LASERS, E1,E6,E14&E20A (K904342)Hgm Medical Laser Systems, Inc.1990-12-19+ Add
HERCULES MODEL 5000 AND 5040 ND:YAG LASER SYSTEMS (K904610)Heraeus Lasersonics, Inc.1990-12-19+ Add
DISPOSABLE FIBER OPTIC DELIVERY SYST/ND: YAG SURG (K904407)Fiber Delivery Concepts, Inc.1990-12-18+ Add
L.P.I. LASER DELIVERY SYSTEM (K904331)Laser Photonics, Inc.1990-12-17+ Add
CENTAURI YAG LASER SYST, OPHTHAMOLOGY (K904630)Pfizer Laser Systems1990-12-17+ Add
CO2 LASERS AND INFRAGUIDE DELIVERY SYSTEM (K904423)Heraeus Lasersonics, Inc.1990-12-13+ Add
MODELS 4000,4900,6000,8000,8900, LUXUS 6&100/1700 (K904444)Heraeus Lasersonics, Inc.1990-12-13+ Add
MULTILASE 45 (K904227)Laser Photonics, Inc.1990-12-12+ Add
MULTILASE 60 (K904229)Laser Photonics, Inc.1990-12-12+ Add
SURGILASE SL 50/60 GOLD SURGICAL LASER SYSTEM (K904203)Surgilase, Inc.1990-12-07+ Add
NIDEK INC. MODEL AC-2000 DERM (K904402)Nidek, Inc.1990-12-07+ Add
FLEXISYS (K904149)Dornier Medtech America, Inc.1990-12-04+ Add
CONTACT FIBERS,SURGICAL PROBES & NON-CONTACT FIBER (K903154)Trimedyne, Inc.1990-11-23+ Add
MEDILAS 4060N FIBERTOM(R) SURGICAL LASER (K904155)Dornier Medtech America, Inc.1990-11-21+ Add
MODEL MC 1100 SURGICAL YAG LASER (K903943)Klinger Micro-Controle Group1990-11-21+ Add
LASERSAT CO2 (K904067)Satelec1990-11-07+ Add
VISIRASER (K904126)Acorn Group, Inc.1990-10-30+ Add
SLT CONTACT LASER SYSTEM ND:YAG MEDICAL LASER SYST (K903936)Surgical Laser Technologies, Inc.1990-10-26+ Add
CARBON DIOXIDE FLOWTHROUGH LASER MIXTURES (K904162)Norco, Inc.1990-10-19+ Add
MDLS 4000/4900/6000/8000/8900/LUXUS 60/100 ND:YAG (K903444)Heraeus Lasersonics, Inc.1990-10-11+ Add
SHARPLAN CO2 LASERS, MODEL NUMBERS 1050 AND 1075 (K903230)Sharplan Lasers, Inc.1990-10-11+ Add
ENDOGUIDE (R), MICROGUIDE (TM), FLEXIGUIDE (TM) (K903079)Luxar Corp.1990-10-04+ Add
CARDIOLASE YAG MODEL 4000 SURGICAL LASER SYSTEM (K902940)Trimedyne, Inc.1990-10-03+ Add
CANDELA SPTL-1 LASER FOR TREATING BENIGN VASC. LES (K900858)Candela Laser Corp.1990-10-03+ Add
OPTILASE YAG MODEL 1000 SURGICAL LASER SYSTEM (K902939)Trimedyne, Inc.1990-10-03+ Add
MODEL IS102S ND:YAG SURGICAL LASER SYSTEM (K902133)Niic U.S.A., Inc.1990-10-02+ Add
PEGASUS W/ACCESSORIES FOR ARTHROSCOPIC APPLICATION (K902947)Pfizer Laser Systems1990-10-02+ Add
PEGASUS WITH ACCESSORIES (K903027)Pfizer Laser Systems1990-10-02+ Add
COHERENT HOLMIUM:YAG SURGICAL LASER (K902990)Coherent Medical Division1990-10-02+ Add
PEGASUS W/ACCESSORIES FOR GENERAL SURGERY (K902946)Pfizer Laser Systems1990-10-02+ Add
CENTAURI ERBIUM YITTRIUM ALUMINUM GARNET LASER (K902534)Pfizer Laser Systems1990-09-25+ Add
OPTILITE FIBEROPTIC DELIVERY SYSTEMS (K902871)Xintec Corporation1990-09-24+ Add
IRIS OCULIGHT SL DIODE LASER PHOTOCOAG/MODIFIED (K903288)Iriderm Div.1990-09-24+ Add
OPTICA 120 ND:YAG SURGICAL LASER SYSTEM (K901710)Xintec Corporation1990-09-20+ Add
COHERENT DIODE PHOTOCOAGULATOR (K903689)Lumenis, Inc.1990-09-20+ Add
VASCULASE(R) COPPER VAPOR LASER SYST, PIGMENT LES (K903883)Metatech Corp.1990-09-19+ Add
NIDEK MODEL AKC-8000 OPHTHALMIC LASER PHOTOCOAGULA (K900890)Nidek, Inc.1990-09-10+ Add
NIDEK, INC. MODEL ADC-8000 DERM (K900925)Nidek, Inc.1990-09-10+ Add
LASERCOMP MODEL STAR 10 FOR KNEE ARTHROSCOPY (K901127)Lasercomp1990-09-10+ Add
MODEL RD-1200 RUBY LASER SYSTEM (K903849)Charles L. Rose and Co., Inc.1990-09-05+ Add
LASER-SHIELD II(TM) (K901016)Xomed, Inc.1990-08-29+ Add
LASER FORCEPS HANDPIECE (K901365)Lca, Inc.1990-08-21+ Add
MODELS IR103,IR107,IR104,IR205 (ADD'L APPLICATION) (K901205)Niic U.S.A., Inc.1990-08-14+ Add
COHERENT XA30/SP AND XA50 SURGICAL LASERS (K902470)Lumenis, Inc.1990-07-26+ Add
SLT CONTACT LASER SYSTEMS (UROLOGY) (K902241)Surgical Laser Technologies, Inc.1990-07-12+ Add
LPI YAG MODEL 1003 SURGICAL LASER SYSTEM (K900837)Laser Photonics, Inc.1990-07-12+ Add
MODELS 4000,4900,6000,8000,8900,LUXUS 60,100,1700 (K902148)Heraeus Lasersonics, Inc.1990-07-10+ Add
MODELS 4000,4900,6000,8000,8900,LUXUS 60,100&1700 (K902061)Heraeus Lasersonics, Inc.1990-07-10+ Add
ADD'L USE OF THE KTP/YAG SURGICAL LASER (K902058)Laserscope1990-06-29+ Add
NIIC MODEL 15 CARBON-DIOXIDE SURGICAL LASER SYSTEM (K902063)Niic U.S.A., Inc.1990-06-29+ Add
SURGILASE YAG 100 SURGICAL LASER SYSTEM (K902211)Surgilase, Inc.1990-06-29+ Add
LASEGUIDE CAT # CLF-600D & CLF-1000D (K901786)Laser Peripherals, LLC1990-06-27+ Add
MODIFIED COMBOLASER 5050 & NEW MODEL 5050 VER. 33 (K901638)Lasermatic, Inc.1990-06-27+ Add
MODEL MC 2100 ND:YAG SURGICAL LASER SYSTEM (K901340)Klinger Medical1990-06-26+ Add
DIAMOND ND:YAG OPHTHALMIC LASER (K901636)Biovision, Inc.1990-06-22+ Add
MODEL YC-1200/PHOTOCOAGULATOR OPHTHALMIC LASER (K901481)Nidek, Inc.1990-06-20+ Add
REVISED LABELING FOR MODEL CL-0PE ND:YAG LASER (K902562)Lca, Inc.1990-06-20+ Add
MODEL 20-CH W/ AR-10A/U OPTICAL ATTACHMENT (K894241)Directed Energy, Inc.1990-06-18+ Add
LASERCOMP MODEL STAR 10 FOR ORAL,GYNECOLOGY SURG. (K901128)Lasercomp1990-06-05+ Add
EXPANDED MARKETING OF MODELS IR104 & IR205 LASERS (K901204)Niic U.S.A., Inc.1990-06-05+ Add
KTP/532 (TM) SURGICAL LASER (K901943)Laserscope1990-05-29+ Add
ENDOSCOPIC USES OF THE ARGON LASER IN GENERAL SURG (K896314)Hgm Medical Laser Systems, Inc.1990-05-10+ Add
MODELS 4000/4900/6000/8000/8900, LUXAS&1700 ND:YAG (K900630)Heraeus Lasersonics, Inc.1990-05-04+ Add
MODEL DLASE 300 ND:YAG LASER SYSTEM: INTRAORAL (K900539)Sunrise Technologies, Inc.1990-05-03+ Add
HERAEUS LASERSONICS CO2 WAVEGUIDE DELIVERY SYSTEM (K900751)Heraeus Lasersonics, Inc.1990-05-03+ Add
HEXASCAN HANDPIECE (K901008)Lihtan Technologies, Inc.1990-05-03+ Add
I.C. MEDICAL ADJUSTABLE DIRECT COUPLER (K900511)I.C Medical, Inc.1990-05-01+ Add
SURGILASE YAG 100 IN ORTHOPEDIC SURGERY (K900570)Surgilase, Inc.1990-05-01+ Add
SURGILASE CO2 SURGICAL LASER SYSTEMS MODEL SL120 (K901227)Surgilase, Inc.1990-04-26+ Add
SURGILASE SL50 SURGICAL LASER SYSTEM (K901211)Surgilase, Inc.1990-04-26+ Add
CL-OPE CONTACT LASER SYSTEM (K900128)Lca, Inc.1990-04-16+ Add
F300 SERIES CONTACT FIBER HANDPIECES (K901021)Hgm Medical Laser Systems, Inc.1990-04-13+ Add
LASER LAPAROSCOPIC CHOLECYSTECTOMY (K901541)Surgical Laser Technologies, Inc.1990-04-13+ Add
SHARPLAN ND:YAG LASERS FOR ENT AND NECK SURGERY (K900345)Sharplan Lasers, Inc.1990-04-10+ Add
KTP/532 SURGICAL LASER SYSTEM W/KTP/YAG MODULE (K895945)Laserscope1990-04-09+ Add
MODEL 20-CH CARBON DIOXIDE LASER W/ADD'L USES (K900253)Pfizer Laser Systems1990-04-05+ Add
SHARPLAN ND:YAG LASER LAPAROSCOPIC CHOLECYSTECTOMY (K900346)Sharplan Lasers, Inc.1990-04-04+ Add
MICRORUPTOR III SYSTEM, CW ND: YAG LASER COMPONENT (K895347)Lasag Medical Lasers1990-04-02+ Add
SHARPLAN MODEL 1055 SEALED CO2 SURGICAL LASER (K900592)Sharplan Lasers, Inc.1990-03-27+ Add
NIDEK, INC. MODELS YC-1100 OPHTHALMIC LASERS (K900166)Nidek, Inc.1990-03-27+ Add
NIDEK, INC. BIO-DC LASER DELIVERY SYSTEM (K900165)Nidek, Inc.1990-03-22+ Add
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