meddevicedb.com FDA Device Reference

Review Panel

Ophthalmic FDA 510(k) Clearances & Devices

Cleared Devices
4,756
Product Codes (page)
57
Latest Decision
1983-06-08

Clearances · page 45 of 48

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K830812 ALPHAMEDIX I/A HAND-PIECE, 500-001 Alphamedix, Inc. HQC Class II 1983-06-08
K831285 SURGICAL/LID MARGIN COVER & EYELASH- Richard R. Anthony, M.D. HOD Class I 1983-06-03
K831388 GLASS FRAMES & COMPONENT PARTS Anamar HQZ Class I 1983-06-02
K830871 PHAKOSYSTEMS MODEL 1000/OMNI PACKS IRRIGATION/ASPIRATION Phakosystems, Inc. HOC Class I 1983-06-02
K831231 LED GOGGLES Cadwell Laboratories, Inc. HLX Class II 1983-05-16
K830902 OCUCARE PACK Ocular Innovations, Inc. HQC Class II 1983-05-16
K830770 CONTRAST SENSITIVITY EQUIPMENT Cadwell Laboratories, Inc. HLX Class II 1983-04-28
K831074 OSCAR COLOR VISION TESTER Carl Zeiss, Inc. HIT Class I 1983-04-28
K830468 MODEL 200 Western Laboratories Corp. FTZ Class I 1983-04-12
K830878 BINOCULAR LOUPE Almore Intl., Inc. HJH Class I 1983-04-06
K830262 FLORET OPHTHALMIC EYE SPEAR Ritmed, Inc. HOZ Class II 1983-04-06
K823088 ASPITRON Intl. Ophthalmic Industries Corp. HQC Class II 1983-04-06
K830774 BINOCULAR MAGNIFIER 2X Almore Intl., Inc. HKC Class I 1983-04-06
K830037 EXTENSION HANDLE FOR ACUTOME PROBE Precision Medical Instruments, Inc. HQE Class II 1983-04-06
K830385 IRRIGATION/ASPIRATION KIT Vxtra Corp. HQC Class II 1983-04-05
K830413 HANDPIECE SYSTEM I/A Uxtra Corp. HQZ Class I 1983-04-05
K830379 PHAKO KIT Vxtra Corp. HQC Class II 1983-04-05
K830474 IV STAND Teknar, Inc. HQC Class II 1983-04-05
K830557 ERG-JET ELECTRODE Universo S.A. HLZ Class II 1983-03-31
K830625 CYTO-STAIN Richard-Allan Medical Ind., Inc. HJQ Class I 1983-03-24
K830496 DMV ANGLER Dmv Contact Lens Co. KYE Class I 1983-03-09
K830336 DORC INTRAOCULAR ELECTROMAGNET Jedmed Instrument Co. HPO Class II 1983-03-09
K830215 DORC LIGHTWEIGHT BINOCULAR OPHTHALMOSCOP Jedmed Instrument Co. HLJ Class II 1983-03-09
K830366 DIAMOND KNIFE Koi, Inc. HNN Class I 1983-03-09
K830290 DORC CONTACT/PHOTO DERATOSCOPE Jedmed Instrument Co. HJA Class I 1983-03-09
K830216 DORC COMPACT MICRO SURGICAL SYSTEM Jedmed Instrument Co. HQE Class II 1983-03-09
K823385 ALES Oms HPG Class I 1983-03-09
K830335 DORC CORNEAL PUNCH BLOCK Jedmed Instrument Co. HNJ Class I 1983-03-09
K822991 AO DOCUSTAR(MMIRO) FUNDUS CAMERA Warner-Lambert Co. HKI Class II 1983-02-24
K823825 NOSITE UV INTERIM SPECTACLES Patton, Boggs & Blow HQG Class I 1983-02-24
K830040 DISPOSABLE CYSTOTOME Contemporary Surgical Systems, Inc. HNY Class I 1983-02-07
K830169 DORC ADJUSTABLE IMAGE CONTACTS Jedmed Instrument Co. HKS Class I 1983-02-07
K830008 KARICKHOFF KERATOSCOPE Surgidev Corp. HLR Class I 1983-01-26
K823901 TREPHINE BLADES-VARIOUS MODELS Edward Weck, Inc. HRG Class I 1983-01-17
K830011 VFS 1000/SCREENING FUNCTION ANALYZER CooperVision, Inc. HOX Class I 1983-01-17
K823835 SPEMBLY 140 CRYOSYSTEM PROBES & TIPS Keller Instruments, Inc. HQA Class II 1983-01-17
K823768 CLIRANS TE08 HOLLOW FIBER DIALYZER Terumo Medical Corp. HRN Class II 1983-01-08
K823767 ERG-JET ELECTRODE Life-Tech Intl., Inc. HLF Class I 1983-01-08
K822908 COHERENT FUNDUSL RETINAL CAMERA Coherent Medical Division HKI Class II 1983-01-05
K821897 LENS Mortan, Inc. KYG Class I 1983-01-05
K823719 AML (ANGLE MAGNIFYING LENS Nikon, Inc. HKI Class II 1983-01-05
K822919 5010 VISUSTIM Life-Tech Intl., Inc. HLX Class II 1982-12-28
K822915 5031 BRIGHT FLASH STIMULATOR Life-Tech Intl., Inc. HLX Class II 1982-12-28
K823222 INTRAOCULAR LENS GUIDE American Medical Optics KYB Class I 1982-12-28
K822922 5011 GANZFELD STIMULATOR Life-Tech Intl., Inc. HLX Class II 1982-12-28
K822923 5012 PARABOLIC STIMULATOR Life-Tech Intl., Inc. HLX Class II 1982-12-28
K823174 MICROSURGICAL INSTRUMENTS Concept, Inc. HNR Class I 1982-11-16
K822272 HEAD MIRRORS W/HEAD LAMPS & HEAD BANDS Kelleher Corp. HPQ Class II 1982-11-10
K822917 MODEL 5400 OPTOKINETIC STIMULATOR Life-Tech Intl., Inc. HOW Class I 1982-11-01
K822828 SOFT LENS THERMAL DISINFECTING UNIT, A-C Safeway Products, Inc. HRD Class II 1982-10-29
K822573 SUNGLASS LENSES ZEISS HQG Class I 1982-10-22
K822853 MODEL 200 SQUID Synemed, Inc. HPT Class I 1982-10-18
K822599 KEATES I/A SYSTEM FRIGITRONICS 4000 Frigitronics of Connecticut, Inc. HKP Class II 1982-10-06
K822220 COOPER VISION I/A SYSTEM III MODEL 1500 CooperVision, Inc. HQE Class II 1982-10-06
K822601 FIXATION MONITOR West Coast Optical Instruments, Inc. HPT Class I 1982-09-30
K822580 AUTO PERIOMETER 3000 Dicon, Inc. HPT Class I 1982-09-30
K822415 THE OCUPLOT D Coherent Medical Division HPJ Class II 1982-09-07
K822215 NIC OPTRONICS CS-2000 Nicolet Biomedical Instruments HOX Class I 1982-08-31
K822151 SURGICAL INSTRUMENTS REPRESENT. 4 CLASS Robert I. Chien & Assoc., Inc. HNF Class I 1982-08-19
K821765 PHOTOTHERAPY EYE PROTECTION FOR INFANTS Russell Terry Co. HOY Class I 1982-08-16
K822104 ALCON INDIRECT OPHTHALMOSCOPE Alcon Laboratories HLI Class II 1982-08-10
K822112 OPHTHALMIC KNIFE Sharpoint, Inc. HNN Class I 1982-08-10
K821932 MENTOR POTENTIAL ACUITY METER Mentor O & O, Inc. HOX Class I 1982-08-03
K821940 THE HUMPHREY FIELD ANALYZER MODEL 610 Zeiss Humphrey System HPT Class I 1982-07-28
K821391 OPHTHALMIC EYEWEAR Nordic Eyewear, Inc. HQZ Class I 1982-06-29
K821398 CORNING CPF 550 LENS Corning Medical & Scientific HQG Class I 1982-06-25
K820877 AUTOMATIC OBJECTIVE REFRACTOR 2000 Dicon, Inc. HKO Class I 1982-06-25
K821082 TRIAL LENS SET Medical Equipment Designs, Inc. HLH Class I 1982-06-14
K821084 UNIVERSAL TRIAL FRAMEE Medical Equipment Designs, Inc. HPA Class I 1982-06-14
K820933 CILCO I/A HANDPIECE Cilco, Inc. HQE Class II 1982-06-14
K821083 P.D. METER Medical Equipment Designs, Inc. HLH Class I 1982-06-14
K821381 IOL FORCEPS Cilco, Inc. KYB Class I 1982-06-14
K821081 CHART PROJECTOR Medical Equipment Designs, Inc. HOJ Class I 1982-06-14
K820375 PLASTIC OR GLASS MAGNIFIER Gazelle Corp. HJF Class I 1982-06-14
K821440 V LANCE Sharpoint, Inc. HNN Class I 1982-06-14
K821286 IRIS SCISSORS STRAIGHT 4 1/2 Conphar, Inc. HNF Class I 1982-05-28
K821290 LITTAUER SCISSORS 5 1/2 Conphar, Inc. HNF Class I 1982-05-28
K821080 HAND KERATOSCOPE Medical Equipment Designs, Inc. HLR Class I 1982-05-24
K820889 ASPIRATOR/IRRIGATOR OR I/A UNIT Mid Laboratories, Inc. KYG Class I 1982-05-05
K820732 LA VEL LATERAL VIEW EXTENSION LENS Peter M. Tolliver HOI Class I 1982-05-03
K820680 DISPOSABLE TUBING SETS Innovative Surgical Products, Inc. KYG Class I 1982-04-09
K820751 GLAUKON Sonometrics Systems, Inc. HKX Class II 1982-04-09
K820254 GOLD FOIL ERG ELECTRODES Cadwell Laboratories, Inc. HLZ Class II 1982-04-09
K820618 MICROSURGERY KNIFE Visitec Co. HNN Class I 1982-04-09
K820526 RELIEF VALVE-HONAN INTRAOC. PRESSURE The Lebanon Corp. LCC Class II 1982-03-25
K820016 UVEX ALPHA, BETA, GAMMA & DELTA SUN Bacou USA, Inc. and Uvex Safety, Inc. HQY Class I 1982-03-19
K813130 SUNGLASSES Panlin Corp. HQG Class I 1982-03-04
K820157 XOMED THERMAL MYRINGOTOMY SYSTEM Xomed, Inc. HQP Class II 1982-03-02
K813548 UVEX MINI-SPECS Bacou USA, Inc. and Uvex Safety, Inc. HOI Class I 1982-03-02
K813315 CALIPER-OPTHALMIC Design Research Assoc., Inc. HOE Class I 1982-03-01
K813313 BIOMICROSCOPY CONTACT LENS Design Research Assoc., Inc. HJO Class II 1982-03-01
K813314 NLD IMPLANT SET Design Research Assoc., Inc. HMX Class I 1982-02-24
K813619 CONPHAR-SCHIOETZ TONOMETER Conphar, Inc. HKY Class II 1982-02-24
K820050 KREMER BLADE GAUGE Accutome, Inc. HOE Class I 1982-02-24
K820008 VERSATOME I Alphamedix, Inc. HQE Class II 1982-02-22
K820026 VITRE CON Medical Instrument Development Laboratories, Inc. HQE Class II 1982-02-05
K813274 BLOOD POOL & SUBVETINAL FLUID ASPIRATOR Optical Micro Systems, Inc. HQE Class II 1982-02-05
K820223 OMS QUARTZ INFUSION CONTACT LENS Optical Micro Systems, Inc. HJI Class I 1982-02-05
K812857 CHARLES MICRO PROBE Mid Laboratories, Inc. HQE Class II 1982-02-05
K813500 OMS INFUSION-ASPIRATION HANDLE Optical Micro Systems, Inc. HQE Class II 1982-02-04

4,756 clearances in the Ophthalmic panel. Data: openFDA.