meddevicedb.com FDA Device Reference

Review Panel

Ophthalmic FDA 510(k) Clearances & Devices

Cleared Devices
4,756
Product Codes (page)
39
Latest Decision
1989-12-18

Clearances · page 35 of 48

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K896198 MAINSTER WIDE FIELD LASER LENS Ocular Instruments, Inc. HJK Class II 1989-12-18
K896305 MULTI-USE I/A HANDPIECE Advanced Surgical Products, Inc. HQE Class II 1989-12-18
K896350 TITAN AIR SPECTACLE FRAME Acces Intl. Eyewear HQJ Class II 1989-12-18
K895846 TWO MIRROR GONIO LENS Ocular Instruments, Inc. HKS Class I 1989-12-18
K895434 ALCON FOLDING FORCEPS Alcon Laboratories HNR Class I 1989-12-04
K896072 D.L. SCOPE OPHTHALMOSCOPE North American Medical Products, Inc. HLJ Class II 1989-11-27
K896171 EYE PATCH Eye Garter Company, Inc. HOY Class I 1989-11-03
K896172 STRAPPED EYE SHIELD Eye Garter Company, Inc. HOY Class I 1989-11-03
K896084 MICROSPEARS Sparta Surgical Corp. HOZ Class II 1989-11-02
K895609 PUPIL PATHWAY ANALYZER (PPA) Pulse Medical Instruments HLG Class I 1989-11-02
K896004 ALCON SURGICAL SPONGE Alcon Laboratories HOZ Class II 1989-11-02
K895475 CANON AUTO REF-KERATOMETER RK-2 Canon USA, Inc. HLQ Class I 1989-10-31
K895364 LID LOC Spectrum Co. HOY Class I 1989-10-31
K894513 DIATHRON(R) DIATHERMY UNIT Intl. Ophthalmic Industries Corp. HJM Class II 1989-10-31
K895575 BIO-RAD MODULAR AIR COMPRESSOR Bio-Rad HKX Class II 1989-10-31
K895213 MICROLASE BY LASER TRABECULOPLASTY Keeler Instruments, Inc. HQF Class II 1989-10-31
K895013 COBO TEMPORARY KERATOPROSTHESIS Ocular Instruments, Inc. MLP Class II 1989-10-31
K894512 PHACOEMULSIFICATION UNIT TO REMOVE CATARAC. LENS Intl. Ophthalmic Industries Corp. HQC Class II 1989-10-17
K894511 MAGNETRON MUNICH MODEL ELECTRONIC CONTROL UNIT Intl. Ophthalmic Industries Corp. HQC Class II 1989-10-17
K895196 MODEL DC-1200 DIODE LASER PHOTOCOAGULATOR Nidek, Inc. HQF Class II 1989-10-16
K894421 WOLDOFF PRISMATIC BICONCAVE LENS Ocular Instruments, Inc. HJK Class II 1989-10-04
K895474 NON-MYDRIATIC RETINAL CAMERA, CR4-45NM DUAL Canon USA, Inc. HKI Class II 1989-10-04
K893171 VISTA STREAK RETINOSCOPE (AC-POWERED) Keeler Instruments, Inc. HKL Class II 1989-09-21
K895371 FLEX EYEWEAR FRAMES Flex Eyewear, Inc. HQZ Class I 1989-09-21
K895300 MULTIPLE MENTAL SPECTACLE FRAMES Optica Trade S.A. HQZ Class I 1989-09-21
K894835 LASERMED* GOGGLES AND SPECTACLES Glendale Protective Technologies, Inc. HQF Class II 1989-09-21
K894724 SAFE-EDGE EYESHIELD Trident Medical Products, Inc. HOY Class I 1989-09-14
K894720 UNIVERSAL EYESHIELD Trident Medical Products, Inc. HOY Class I 1989-09-14
K894018 RELIANCE(R) 6200 EXAMINATION CHAIR Reliance Medical Products, Inc. HME Class I 1989-09-12
K895010 MENTOR SPECTACLE BINOCULAR INDIRECT OPHTHALMOSCOPE Mentor O & O, Inc. HLI Class II 1989-09-11
K893968 VKG 2000 VIDEO KERATOMETER Technitex, Inc. HJA Class I 1989-09-11
K890687 ECT-100 ELECTRONIC CORNEAL TOPOGRAPHER Optimed, Inc. HLQ Class I 1989-09-05
K891137 MOTILITY ORBITAL IMPLANT Integrated Orbital Implants, Inc. HPZ Class II 1989-08-24
K893987 NIDEK MODEL YC-1200 Nidek, Inc. LXS Class II 1989-08-18
K893731 SHIELDS T.C. LASER LENS Ocular Instruments, Inc. LQJ Class II 1989-08-17
K891487 SOFT LENS FOLDING BLOCK Western Medical Products, Inc. HNR Class I 1989-08-15
K894278 STORZ DAISYPLUS SERIES MICROSURGICAL SYSTEMS Storz Instrument Co. HQE Class II 1989-08-11
K894273 NIDEK MODEL AKC-8000 Nidek, Inc. HQF Class II 1989-08-07
K890195 JAMES SURGICAL SYSTEM J1000 O.R. Specialties, Inc. HQE Class II 1989-08-03
K893630 CANDELA UPC LASER PHOTOCOAGULATOR Candela Laser Corp. HQF Class II 1989-08-02
K893986 NEW WEST SUNGLASSES New West Promotions HQY Class I 1989-07-25
K882384 DELUXE CONTACT LENS HOLDER (HARD & SOFT) #283 Magnivision, Inc. LRX Class II 1989-06-23
K892372 SPIN-CLEAN CLEANING UNIT Willmar Contact Lens Co. LYL Class II 1989-06-23
K890782 GRIESHABER SOFT TIP NEEDLE (20 & 19 GAUGES) Grieshaber & Co. HMX Class I 1989-06-23
K885015 COI 72 HR COLLAGEN SHIELD Chiron Ophthalmics MOE Class I 1989-06-23
K890533 ITEM #352/#CS352* CONTACT LENS CASES Magnivision, Inc. LRX Class II 1989-06-23
K892204 NIDEK INC. MODELS YC-2000 & 3000 OPHTHALMIC LASERS Nidek, Inc. LXS Class II 1989-06-22
K893199 PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTR Allergan Medical Optics HNR Class I 1989-06-16
K892058 ISL QC 2000 Intelligent Surgical Lasers, Inc. LXS Class II 1989-06-15
K893709 COHERENT MARIE ARGON PHOTOCOAGULATOR Coherent Medical Group HQF Class II 1989-06-15
K892852 SITE PHACO PLUS INFUSION SLEEVE Site Microsurgical Systems, Inc. HQC Class II 1989-06-08
K891610 HENSON CFA 3000 CENTRAL VISUAL FIELD SCREENER Keeler Instruments, Inc. HOD Class I 1989-06-05
K893173 VISTA SPECIALIST OPHTHALMOSCOPE (BATTERY & AC) Keeler Instruments, Inc. HLI Class II 1989-06-05
K893172 VISTA OPHTHALMOSCOPE (BATTERY AND AC-POWERED) Keeler Instruments, Inc. HLI Class II 1989-06-05
K893170 VISTA FINOFF TRANSILLUMINATOR (AC-POWERED) Keeler Instruments, Inc. HJM Class II 1989-06-05
K891161 VITRECTOMY PACK #J120 O.R. Specialties, Inc. HQC Class II 1989-05-26
K892349 MAGNILINK SYSTEM 209 Coburn Optical Ind., Inc. HJG Class I 1989-05-26
K892347 MAGNILINK SYSTEM 101 Coburn Optical Ind., Inc. HJG Class I 1989-05-26
K890825 JUMPER PACK #203 O.R. Specialties, Inc. HQC Class II 1989-05-26
K892350 MAGNILINK SYSTEM 402/5 Coburn Optical Ind., Inc. HJG Class I 1989-05-26
K892348 MAGNILINK SYSTEM 201 Coburn Optical Ind., Inc. HJG Class I 1989-05-26
K892351 MAGNILINK SYSTEM 602 Coburn Optical Ind., Inc. HJG Class I 1989-05-26
K891601 POWER OPERATED AND CONTROLLED VITREOUS SCISSORS Mira, Inc. HQE Class II 1989-05-23
K890977 MCINTYRE SURGICAL GONIOLENS Ocular Instruments, Inc. HKS Class I 1989-05-23
K885230 MCDONALD FOLDING FORCEPS Alcon Laboratories HNR Class I 1989-05-17
K892911 SITE PERISTALTIC CASSETTE Site Microsurgical Systems, Inc. HQC Class II 1989-05-17
K890992 WOODLYN OPHTHALMIC PROJECTOR Woodlyn, Inc. HOS Class I 1989-05-17
K884557 ADVANCED SURGICAL PRODUCTS SCISSORS HANDPIECE Advanced Surgical Products, Inc. HQE Class II 1989-05-12
K890635 CAVITRON/KELMAN PHACOEMULSIFIER ASPIRATOR, UNIV. CooperVision, Inc. HQC Class II 1989-05-09
K890622 SURG-E-TROL SYSTEM I AND SYSTEM II Mentor O & O, Inc. HQE Class II 1989-05-04
K891597 NOSEY SHADES (SUNGLASSES) NONPRESCRIPTION Creative Images, Inc. HQY Class I 1989-04-19
K890725 PHOTOCHROMIC LENS Ppg Industries, Inc. HQY Class I 1989-04-19
K890300 INTERCASSETTE, INTERKIT, UNIVERSAL PAK & CASSETTE CooperVision, Inc. HQE Class II 1989-04-17
K890595 MENTOR ANTERIOR SEGMENT VITRECTOR Mentor O & O, Inc. HKP Class II 1989-04-17
K890133 OCULAR CONNECTION MACHINE(TM) Innovision Medical, Inc. HQE Class II 1989-04-12
K890080 PHACOEMULSIFIER MODEL 100 Sonic Needle Corp. HQC Class II 1989-04-06
K890509 INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEM Biophysic Medical, Inc. HQF Class II 1989-03-24
K890086 MICROLASE 8 0 0 (OPHTHALMIC LASER) Keeler Instruments, Inc. HQF Class II 1989-03-15
K890081 CALIUS-ISABEL CANOVAS SUNGLASSES Roseburg SA HQY Class I 1989-03-09
K884867 OPTIFIELD I AND II AUTOMATED PERIMETERS Optimed, Inc. HPT Class I 1989-03-09
K884556 DREYER CURVED ENDOILLUMINATOR Advanced Surgical Products, Inc. HQE Class II 1989-02-28
K884989 NEVISCAN MODEL N - 100 Special Products, Inc. HKI Class II 1989-02-28
K890544 SHAPIRO CUTTER H.S. Intl. Co., Inc. HQE Class II 1989-02-28
K890598 MOLTENO IMPLANT Iop, Inc. KYF Class II 1989-02-27
K890559 NIDEK AR-1200 Nidek, Inc. HKO Class I 1989-02-27
K884878 SOLARETTES Dioptics HQY Class I 1989-02-22
K890303 OPTI-TEARS(R) Alcon Laboratories LPN Class II 1989-02-17
K884241 STAAR PHACO XL SMALL INCISION SYSTEM Staar Surgical Co. HQC Class II 1989-02-17
K884960 ADDIT. INDICATION FOR FYODOROV COLLAGEN CORNEAL Bausch & Lomb Pharmaceutical, Inc. MOE Class I 1989-02-13
K884961 ADDIT. INDICATIONS FOR BIO-COR II COLLAGEN CORNEAL Bausch & Lomb Pharmaceutical, Inc. MOE Class I 1989-02-13
K885232 FLUID DRAINAGE WICK Visitec Co. HOZ Class II 1989-02-08
K885016 COI 24 HR COLLAGEN SHIELD Chiron Ophthalmics MOE Class I 1989-02-01
K884924 VISI-WIPE Visitec Co. HOF Class I 1989-01-31
K885125 KRUPIN EYE VALVE W/SCLERAL BUCKLE Hood Laboratories KYF Class II 1989-01-24
K885275 ASSENAT-BLESCHET SUNGLASSES Roseburg SA HQY Class I 1989-01-24
K882517 RODENSTOCK SCANNING LASER OPHTHALMOSCOPE Rodenstock Instrument Corp. HLI Class II 1989-01-24
K884540 ETV, ELECTRONIC VISION AID Sevrain-Tech, Inc. HPE Class I 1989-01-19
K885196 LASER INDIRECT OPHTHALMOSCOPE (LIO) Coherent Medical Group HQE Class II 1989-01-11
K885164 LASAG MICRORUPTOR 2 ND:YAG OPHTH. LASER SYSTEM Chiron Vision Corp. HQF Class II 1989-01-10
K884012 MMAC II TONOMETER Professional Technologies Corp. HKX Class II 1989-01-06

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