meddevicedb.com FDA Device Reference

Review Panel

Ophthalmic FDA 510(k) Clearances & Devices

Cleared Devices
4,756
Product Codes (page)
43
Latest Decision
1986-01-22

Clearances · page 41 of 48

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K854197 IOSERT LENS IMPLANT INSTRUMENT Chiron Vision Corp. KYB Class I 1986-01-22
K854422 SERIES 25 SLIMLINE CRYO PROBES Keeler Instruments, Inc. HQA Class II 1985-12-30
K854401 THE NEW MOBILE TIP MCINTYRE CANNULA Microsurgical Technology, Inc. HMX Class I 1985-12-30
K854411 KEELER-COMPACT CRYO SYSTEM Keeler Instruments, Inc. HQA Class II 1985-12-30
K854402 THE NEW MCINTYRE I.A. HANDPIECE Microsurgical Technology, Inc. HMX Class I 1985-12-30
K854375 COOPERVISION ACAP POWER DRIVE ULTRASONIC ANTERIOR CooperVision, Inc. HQC Class II 1985-12-27
K854225 ALLERGAN I.S.P. MODEL 3000 OPHTHALMIC SURGICAL-SYS Advanced Medical Technology, Inc. HQC Class II 1985-12-27
K854054 PLACIDO DISC Cutler Medical Instruments HLR Class I 1985-12-27
K854116 PHACO PACKS, 1A PACKS & PACK COMPONENTS Medical Corp. of America HQC Class II 1985-12-27
K844373 O.M.S. ULTRA-PHACO Optical Micro Systems, Inc. HQC Class II 1985-12-19
K853430 STORZ IAS DISPOSABLE PACK Storz Instrument Co. HQE Class II 1985-12-16
K853961 VISITEC OPHTHALMIC ASPIRATION UNIT MODEL 100 Visitec Co. HQE Class II 1985-12-13
K854047 IN-HOME VISION MONITORING KIT Rich-Larky Company, Inc. HOX Class I 1985-12-13
K854330 IS-2000 DIGITAL OPHTHALMIC IMAGING SYSTEM Par Technology Park HKI Class II 1985-12-13
K853043 700-123 EYE SHADE Health Saver Products HQY Class I 1985-12-13
K853035 HESSBURG LIGHT GUARD Visitec Co. HOY Class I 1985-12-13
K853758 PY-RITE Golden Dental Products, Inc. NJH Class I 1985-12-03
K853777 THE NEW MCINTYRE CANNULA Microsurgical Technology, Inc. HMX Class I 1985-11-21
K854264 SUNGLASSES/OPTICAL FRAMES Wha Chun Industries, Co., Ltd. HQY Class I 1985-11-12
K854244 THE KEELER ALL PUPIL INDIRECT OPHTHALMOSCOPE Keeler Instruments, Inc. HLI Class II 1985-11-12
K853890 OPHTHALMIC LASER PHOTOCOAGULATOR Mira, Inc. HQF Class II 1985-11-12
K854218 THE ULTRA-MATE LENS Optical Systems Intl., Inc. HQG Class I 1985-11-12
K853290 TECHNA VISION AUTO-PERIMETER Techna Vision HPT Class I 1985-11-12
K854288 OPHALMIC LASER PHOTOCOAGULATOR Mira, Inc. HQF Class II 1985-11-12
K854343 SIOM South West Intl., Inc. HQZ Class I 1985-11-12
K854383 KERATOLUX Carl Zeiss, Inc. HPL Class I 1985-11-12
K853403 STORZ DIAMOND KNIFE Storz Instrument Co. HNN Class I 1985-11-04
K852828 BEAVER R-K KNIFE Rudolph Beaver, Inc. HNN Class I 1985-11-04
K852633 VERSABLADE Alphamedix, Inc. HNN Class I 1985-11-04
K853598 OPHTHALMIC KNIFE W/REMOVALE DEPTH GUIDE Myocure, Inc. HNN Class I 1985-11-04
K853063 SMARTKNIFE SYSTEM CooperVision, Inc. HNN Class I 1985-11-04
K852706 VERSABLADE Alphamedix, Inc. HNN Class I 1985-11-04
K853556 LASER IRAS Randwal Instrument Co., Inc. HPJ Class II 1985-11-01
K853812 PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION) Biosan Laboratories, Inc. HLX Class II 1985-11-01
K853736 MENTOR BRIGHTNESS ACUITY TESTER Mentor O & O, Inc. HOX Class I 1985-11-01
K853481 VISTECH VCTS GLARE TESTER Vistech Consultants, Inc. HOX Class I 1985-10-29
K853744 TECHNA VISION, INC.ELECTRIC TABLE Techna Vision HRJ Class I 1985-10-17
K853743 TECHNA VISION, INC. ELECTRIC CHAIR Techna Vision HME Class I 1985-10-17
K853668 ORC ORACLE Optical Radiation Corp. HLQ Class I 1985-10-15
K853723 ZEISS OPERATING KERATOMETER Carl Zeiss, Inc. HLQ Class I 1985-10-15
K853921 ALL KINDS OF SUNGLASSES Winsburn Company , Ltd. HQY Class I 1985-10-15
K853457 COBURN I/A SYSTEM Coburn Optical Ind., Inc. HQE Class II 1985-10-15
K852936 THE FIELDMASTER MODEL 275 Synemed, Inc. HPT Class I 1985-10-15
K853883 TUBING A VIT, VIT, FRAG PACKS & NEEDLE & CLEAN WIR Medical Corp. of America HQC Class II 1985-10-08
K853358 RELIANCE PENDULUM OPHTHALMIC DELIVERY SYSTEM Dentsply Intl. HMF Class I 1985-10-04
K853891 INDIRECT OPHTHALMOSCOPE Carl Zeiss, Inc. HLJ Class II 1985-10-04
K852404 LASERSAFE EYE SHIELDS Lasersafe, Inc. HOY Class I 1985-10-04
K853790 BABE SHADE-INFANT AMBIENT LIGHT INTENSITY REDUCER Rocky Mountain Medical Corp. HQY Class I 1985-10-04
K853382 MAID MENTOR ASPIRATION/IRRIGATION DEVRO Mentor O & O, Inc. HQE Class II 1985-10-04
K853308 KEATES IRRIGATION/ASPIRATION/VITREOUS CUTTER 5000 Frigitronics of Connecticut, Inc. HQE Class II 1985-10-04
K853499 MICRON-SCOPE Magnum Diamond, Inc. HNN Class I 1985-09-24
K853359 RELIANCE 1379 Dentsply Intl. HRJ Class I 1985-09-24
K853189 CREAT BRAND I/A PACK CREAT BRAND PHACO PACK Aesthetech Corp. HQC Class II 1985-09-24
K852529 HESSBURG GLIDE UNTRAOCULAR LENS GUIDES Visitec Co. HQF Class II 1985-09-24
K852639 HUMPHREY FIELD ANALYZER MODEL 630 Zeiss Humphrey System HPT Class I 1985-09-18
K852424 ACUFEX COMPARATIVE SURGICAL KERATOMETER Acufex Microsurgical, Inc. HJB Class I 1985-09-11
K853243 VISITEC IRRIGATION CONTROL SYSTEM Visitec Co. KYG Class I 1985-09-11
K850984 MARLIN SOFT LENS HANDLER Marlin Industries KYE Class I 1985-09-10
K850983 MARLIN SOFT LENS TWEEZER Marlin Industries KYE Class I 1985-09-10
K852953 #SM-3001 OPHTHA OTOSC SET SUBSETS SOLD Design Med. Corp. HLJ Class II 1985-09-06
K853149 RELIANCE 1000, RELIANCE 1500, RELIANCE 2000 F. & F. Koenigkramer HME Class I 1985-09-05
K853150 RELIANCE 6100 F. & F. Koenigkramer HME Class I 1985-09-05
K853151 RELIANCE 5000 F. & F. Koenigkramer HME Class I 1985-09-05
K852054 CONTACT LENS LOUPE, INSPETION LOUPE Ascon Medical Instruments, Ltd. HLN Class I 1985-09-05
K852055 ASCON OPHTHALMIC SPONGE Ascon Medical Instruments, Ltd. HOZ Class II 1985-09-04
K852386 SOFT MATE AUTOMATIC CONTACT LENS CLEANING UNIT Barnes-Hind, Inc. LPN Class II 1985-09-04
K851410 O.M.S. UV-COLOURS Optical Moulding Systems HQG Class I 1985-08-27
K844448 OMS/GONVERS RETINAL PERFORATOR Optical Micro Systems, Inc. HNM Class I 1985-08-21
K852403 AURALITE II Aura Lens Products HQG Class I 1985-08-20
K852075 SITE-MALIS BIPOLAR COAGULATOR MODULE Valley Forge Scientific Corp. HQO Class II 1985-08-20
K851936 STAAXL-3 SMALL INCISION SYSTEM TM, PHACOFRAGMENTAT Staar Surgical Co. HQE Class II 1985-08-20
K852208 PHACO-BAC STOP FILTER KIT Staar Surgical Co. HQC Class II 1985-08-20
K853070 COOPER VISION SYSTEM VI U/S MODULE CooperVision, Inc. HQC Class II 1985-08-20
K852774 OCULAB TONOPEN Oculab, Inc. HKY Class II 1985-08-20
K844775 EFFNER-EYE CAUTERY WITH BATTERY HANDLE Mecron Medical Products, Inc. HQO Class II 1985-08-12
K852902 METALLIC SUNGLASSES Yours Enterprise Co., Ltd. HQY Class I 1985-08-12
K852032 OCULAR PRESSURE REDUCER (MCCANNEL) Visitec Co. LCC Class II 1985-08-12
K852638 HUMPHREY IMAGE ANALYZER MODEL 110 Zeiss Humphrey System HKI Class II 1985-08-12
K852271 CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRATOR, 9001 CooperVision, Inc. HQE Class II 1985-08-09
K853135 VISITEC 2 MICRON FLUID FILTER Visitec Co. HQE Class II 1985-08-09
K853110 SPECTACLE PRESCRIPTION LENSES Ancie Laboratories HQG Class I 1985-08-09
K852934 PRECISION - COSMET CAPSULE COUPEUR Precision-Cosmet Co., Inc. HNY Class I 1985-08-08
K852830 SUNNY SUN MAGNIFYING GLASSES Sunny Optical Co., Ltd. HQY Class I 1985-08-08
K852773 SUNGLASSES Pony Industries Co., Ltd. HQY Class I 1985-08-08
K853129 BEAVER MULTIPURPOSE SAPPHIRE KNIFE Rudolph Beaver, Inc. HNN Class I 1985-08-06
K851674 PHAKOSYSTEMS MODEL CES 4100 Phakosystems, Inc. HQC Class II 1985-08-05
K852234 MDS 83 OPHTHALMIC DYE LASER SYSTEM Meditec, Inc. HQF Class II 1985-08-01
K852758 INFUSION CANNULAM Precision Medical Instruments, Inc. HMX Class I 1985-08-01
K843957 ULTRATHIN/SP LENS Optical Systems Intl., Inc. HRG Class I 1985-07-31
K852548 ATL 225 MW TRAIL LENS SET Ascon Medical Instruments, Ltd. HPA Class I 1985-07-31
K851698 ANNE MARIE PERRIS SUNGLASSES AND FRAMES Perlinea Co. HQY Class I 1985-07-31
K852464 HCG, INC. MEDICAL LASER ENDOCOAGULATOR MODEL P.C. Hcg, Inc. HQF Class II 1985-07-25
K851610 COMBINED MVS SYSTEMS Medical Instrument Development Laboratories, Inc. HQE Class II 1985-07-22
K843227 MACULAR FUNCTION ANALYZER Danek Medical, Inc. HOQ Class I 1985-07-22
K851272 VERSAPHAGE Alphamedix, Inc. HQE Class II 1985-07-05
K852057 ASCON SURGICAL INSTRUMENTS Ascon Medical Instruments, Ltd. HNR Class I 1985-06-27
K844895 OMS SILICONE OIL INJECTOR Optical Micro Systems, Inc. LWL Class III 1985-06-24
K851768 13-550,13-560 WESCOTT SCOSSORS (EYE) Artiberia HNF Class I 1985-06-20
K852334 MODEL BX OPHTHALMOSCOPE(BX-RP INCLUDES BATTE HAN) Design Med. Corp. HLJ Class II 1985-06-18
K852056 ACC CROSS CYLINDERS Ascon Medical Instruments, Ltd. HPC Class I 1985-06-05

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