meddevicedb.com FDA Device Reference

Review Panel

Ophthalmic FDA 510(k) Clearances & Devices

Cleared Devices
4,756
Product Codes (page)
57
Latest Decision
1980-06-04

Clearances · page 47 of 48

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K801078 PERFECTEMP OPHTHALMIC CAUTERY Medical Products Development, Inc. HQP Class II 1980-06-04
K801196 LIBCO SUNGLASSES Libco Eyewear, Inc. HQY Class I 1980-05-28
K800722 AUTO-FIELD D AUTOMATED VISUAL DETECTOR Cavitron Corp. HPT Class I 1980-04-29
K800368 OPHTHALMIC FORCEPS Edward Weck, Inc. HNR Class I 1980-03-12
K800521 THE LENS OR OMMI-GARD Gentex Corporation HQG Class I 1980-03-12
K800112 AMBLYOPIA TRAINER Life-Tech Instruments, Inc. HPL Class I 1980-03-10
K800238 MOIRE FRINGE VISOMETER AFTER LOTMAR Hagg-Streit Service, Inc. HKL Class II 1980-03-10
K800140 SILASTIC SCLERAL SPONGE II W/CIRCLING BD Dow Corning Corp. Healthcare Industries Materials HQX Class II 1980-03-03
K800089 CRAWFORD LACRIMAL INTUBATION SET Jedmed Instrument Co. HNL Class I 1980-03-03
K800110 X-FLO Contemporary Surgical Systems, Inc. HQE Class II 1980-02-06
K792066 M.P.I. LENS GLIDE J. Leon Bilby KYB Class I 1980-01-29
K791923 SCLERAL POWDER Ocularists , Ltd. HQH Class I 1980-01-10
K792383 KELMAN DIPSTICK V. Mueller O.V. Baxter Healthcare Corp. HOE Class I 1979-12-11
K792255 NEVYAS AUTOPRESS EYE COMPRESSOR Keeler Optical Products , Ltd. LCC Class II 1979-12-11
K791510 BLUE FIELD ENTOPTOSCOPE BFE100 Medical Instrument Research Assoc., Inc. HLI Class II 1979-12-11
K791901 BARNES-HIND WETTING & SOAKING SOLUTION Barnes-Hind, Inc. HQG Class I 1979-11-16
K790526 LIO-714 OPACITYMETER Laser Industries , Ltd. HJL Class I 1979-11-16
K791763 (MICRO-KERATRON, MICRO DUCT TREPHINE) Intl. Ophthalmic Industries Corp. HRG Class I 1979-11-05
K791898 OCUTOME MODEL 8000 Cooper Medical Devices Corp. HKP Class II 1979-10-30
K791521 VERI-VU LENSOMETER Intermedics, Inc. HLM Class I 1979-10-30
K791917 X-PAK Contemporary Surgical Systems, Inc. HMX Class I 1979-10-30
K791988 REPL. PISTON FOR TROUTMAN CORNEAL PUNCH Edward Weck, Inc. HNJ Class I 1979-10-30
K791721 ULTRAVUE BLENDED BIFOCAL LENS American Optical Corp. HQG Class I 1979-10-23
K791659 MEDITEC (RODENSTOCK) LASER PHOTOCOAGUL Coburn Optical Ind., Inc. HQF Class II 1979-10-11
K791983 SPATULA'S #'S 7618,7248,7240,7242,5108 Edward Weck, Inc. HND Class I 1979-10-04
K791985 HOOKS #'S 7600,7602,7603,7616 Edward Weck, Inc. HNQ Class I 1979-10-04
K791980 TOME'S #'S 1221,1222,1223,1314,6640,6642 Edward Weck, Inc. HNN Class I 1979-10-04
K791981 SWAN KNIFE NEEDLE 1.5MM CAT # 1170 Edward Weck, Inc. HNN Class I 1979-10-04
K791982 CANNULA'S CAT #'S 6636, 6624, 6625 Edward Weck, Inc. HMX Class I 1979-10-04
K791986 FIX. & LENS FOR. #'S 3510,3512,3248,3795 Edward Weck, Inc. HNR Class I 1979-10-04
K791000 VITREOUS SUCTION/CUTTER Concept, Inc. HKP Class II 1979-09-04
K790893 STAT Varian Assoc., Inc. HKP Class II 1979-08-28
K790637 COMPUTERIZED ELECTRO-OCULOGRAPH Potomac Medical System HLX Class II 1979-08-28
K791499 RAY-BAN SUN GLASSES Bausch & Lomb, Inc. HQY Class I 1979-08-28
K791212 VITRECTOMY INTEGRATING TRAY OCUTOME/FRAG Precision Medical Instruments, Inc. HQE Class II 1979-08-10
K791295 BAYLOR VISUAL FIELDS PROGRAMMER Schiff Harding Waite HPT Class I 1979-08-10
K790909 OPHTHALMIC DRESSING TRAY Pent-Cal, Inc. HOX Class I 1979-08-03
K791351 CEMENT SPACERS Depuy, Inc. KYB Class I 1979-08-03
K791104 B & L OPHTHALMIC INSTRUMENT STAND Bausch & Lomb, Inc. HMF Class I 1979-07-24
K791105 B & L OPHTHALMIC CHAIR Bausch & Lomb, Inc. HMF Class I 1979-07-24
K791112 LIBCO 1,2,3, EYEGLASS FRAMES Libco Eyewear, Inc. HQZ Class I 1979-06-15
K790266 SPECTACLE FRAMES Alva-Tech, Inc. HQZ Class I 1979-04-04
K790215 LENS, POLYCORE Polycore Optical Pte , Ltd. HQG Class I 1979-02-26
K790251 FUL-VUE ASPHERIC CATARACT LENS American Optical Corp. HQG Class I 1979-02-26
K782169 NEEDLES, CANNULAS, CYSTOTOMES Visitec Co. HMX Class I 1979-02-13
K781994 AUTOKERATOMETER, INSTRUMENT Zeiss Humphrey System HLQ Class I 1979-02-12
K782140 REMOVER, SOFT-SERT CONTACT LENS Mcmurray and Pendergost KYE Class I 1979-02-12
K790102 MODEL 556-01 CRYOEXTRACTOR Intermedics, Inc. HPS Class II 1979-02-12
K790244 CYSTOTOMES Visitec Co. HNY Class I 1979-02-12
K781338 BEAVER CATARACT CYROXTRACTOR Edward Weck, Inc. HPS Class II 1979-02-12
K790243 CANNULAS Visitec Co. HMX Class I 1979-02-12
K781960 SURGICAL EYE SHIELD Concept, Inc. HJK Class II 1979-02-09
K782106 COAGULATOR, MODEL 40 AARGON Lasertek OY HQF Class II 1979-02-08
K781965 LASER COAGULATOR, MODEL 41AK Lasertek OY HQF Class II 1979-02-08
K782096 INSTRUMENTS, OVERREFRACTION SYSTEM Zeiss Humphrey System HLM Class I 1979-01-26
K782141 LEVIGATOR, KEELER PHOKO Keeler Optical Products , Ltd. HQC Class II 1979-01-26
K782118 FUL-VUE American Optical Corp. HKN Class I 1979-01-26
K781313 VISION-STIMULATOR, CAM Clement Clarke, Inc. HPL Class I 1979-01-26
K782065 LASER, PHOTOCOAGULATION Cavitron Corp. HQF Class II 1978-12-28
K781927 HUMAN II LENS Spectra-Shield, Inc. HQG Class I 1978-12-20
K781892 LOCATOR, FOREIGN BODY Keeler Optical Products , Ltd. HPM Class II 1978-12-04
K781715 RULER, WECK SCOTT Edward Weck, Inc. HOE Class I 1978-12-04
K781507 RETINOMETER Coburn Optical Ind., Inc. HPJ Class II 1978-11-15
K781476 MULAR GOLD LEAF ELECTRODE MODEL 7501 Life-Tech Instruments, Inc. HLZ Class II 1978-11-15
K781471 PNEUMATIC VITRECTOMY CONTROL UNIT Helfgott Medical Instruments HQE Class II 1978-11-08
K781801 MAXI-CHAIR Surgical Mechanical Research, Inc. HME Class I 1978-11-03
K780852 CLINITEX VIS-X ASPIRATING ACCESSORY Varian Assoc., Inc. HKP Class II 1978-11-03
K781452 BAYLOW VISUAL ACUITY TESTER Codman & Shurtleff, Inc. HOX Class I 1978-10-24
K781543 ORBIOGRAPH Sonometrics Systems, Inc. HLT Class II 1978-10-24
K781459 MONOJECT SCALE MAGNIFIER Sherwood Medical Industries HJY Class I 1978-10-24
K781650 TERRY KERATOMETER Clifford M. Terry, M.C. HJA Class I 1978-10-17
K781658 PROJECTOR, ACCU-CHART ACUITY Bausch & Lomb, Inc. HOS Class I 1978-10-17
K781412 OSCILLATING KNIFE AND ACCESSORIES Codman & Shurtleff, Inc. HMY Class I 1978-10-11
K780987 SOFT SILICONE ELASTOMER SPONGE EXPLANT Medical Instrument Research Assoc., Inc. HOZ Class II 1978-09-28
K781105 TONOMETER, DIGITON Ical, Inc. HKY Class II 1978-09-27
K781411 CORNEAL CUTTER AND ACCESSORIES Codman & Shurtleff, Inc. HRH Class I 1978-09-20
K781465 MICROSURGICAL KNIVES, 20, 30, 45 Codman & Shurtleff, Inc. HNN Class I 1978-09-20
K781462 AUTO-FIELD II OPHTHALMIC FIELD SCANNER Cavitron Corp. HPT Class I 1978-09-14
K781440 LENSOMETER MODEL 11 Rodenstock Instrument Corp. HLM Class I 1978-09-07
K781014 AUTOREFRACTOR, SUBJECTIVE Cavitron Corp. HKO Class I 1978-09-07
K781356 IMPLANT, EYE SPHERE Mcghan Medical Corp. HPZ Class II 1978-08-21
K780851 CHARLES ENDOCOAGULATOR ACCESSORY FOR ARC Varian Assoc., Inc. HOB Class I 1978-06-30
K780931 SOFT LENS INSERTER Soft-Sert KYE Class I 1978-06-28
K780433 FIBER OPTIC ADJUSTABLE HEADLIGHT Cameron-Miller, Inc. FCT Class II 1978-06-13
K780663 CONTACT LENS REMOVER AND INSERTER Dmv Contact Lens Co. KYE Class I 1978-05-17
K780664 SOFT LENS REMOVER/INSERTER/MANIPULATOR Dmv Contact Lens Co. KYE Class I 1978-05-17
K780345 PHOTOCOAGULATOR LASER Cavitron Corp. HQB Class II 1978-05-09
K780414 OCTOPUS Hitron Corp. HPT Class I 1978-04-10
K780215 EYESCOPE Visual Methods, Inc. HLJ Class II 1978-04-10
K780154 NEEDLEHOLDER, MICROVASULAR 5 1/2 Edward Weck, Inc. HNM Class I 1978-03-17
K780257 MICROSPEARS Sparta Instrument Corp. HOZ Class II 1978-02-23
K772221 LENS, HARD RESIN Borani Intl. HQG Class I 1978-01-30
K772368 SPECTACLE FRAME, OP-TITE Dentsply Intl. HQZ Class I 1978-01-30
K771933 CILCO ANTERIOR CHAMBER LENS California Intraocular Lens HQL Class III 1978-01-26
K772204 EYEGLASS FRAMES Logo Paris, Inc. HQZ Class I 1978-01-05
K772214 OPHTHALMOSCOPE, BINOCULAR, INDIRECT Varian Assoc., Inc. HLI Class II 1977-12-13
K772213 LAMP DELIVERY SYS.-PHOTOCOAGULATION Varian Assoc., Inc. HQB Class II 1977-12-13
K772168 MOLDEYE Robert B. Scott Ocularists of Florida, Inc. HQN Class II 1977-11-30
K772130 OCULAR CEREBRAL VASCULAR MONITOR Digilab, Inc. HKY Class II 1977-11-28
K772124 LENSES, EYEGLASS, SAFETY Techsight Corp. HQG Class I 1977-11-16

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