meddevicedb.com FDA Device Reference

Review Panel

Ophthalmic FDA 510(k) Clearances & Devices

Cleared Devices
4,756
Product Codes (page)
31
Latest Decision
1985-06-05

Clearances · page 42 of 48

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K851211 PHACO PAK I United Sonics, Inc. HQC Class II 1985-06-05
K844357 SYSTEM 920 ARGON/DYE PHOTOCOAGULATOR Coherent Medical Group HQF Class II 1985-06-05
K852126 ATF 101 TRAIL FRAME Ascon Medical Instruments, Ltd. HPA Class I 1985-06-05
K851212 UNITED SONICS PACO SYSTEM MODEL 3000 United Sonics, Inc. HQC Class II 1985-05-31
K851298 MID LABS MVSXI United Sonics, Inc. HQC Class II 1985-05-31
K851210 UNITED SONICS PHACO MODULE, DF-35 United Sonics, Inc. HQC Class II 1985-05-31
K851209 CILCO/UNITED SONICS PHACE PF-9000 United Sonics, Inc. HQC Class II 1985-05-31
K851557 ANESTHESIOMETER Luneau SA HJC Class I 1985-05-30
K851661 SOLEX & SAXON INT'L OPTICAL OF HONG KONG South West Intl., Inc. HQZ Class I 1985-05-30
K851130 SPECTACLE FRAME New Brillette A/S HQZ Class I 1985-05-30
K851791 37-610 TO 37-880 VARIOUS OPHTHAL-FORCEPS Artiberia HNR Class I 1985-05-30
K851163 SUNGLASES Full See Glasses Ind. Co., Ltd. HQG Class I 1985-05-30
K851792 37-940 TO 37-944 VARIOUS NOYES OPHTHALMIC FORCEPS Artiberia HNR Class I 1985-05-30
K851790 37-200 TO 37-246 VARIOUS OPHTHALMOLOGY SCALPELS/KN Artiberia HNN Class I 1985-05-23
K851555 OPTHALMIC BAR PRISM Roseburg SA HKW Class I 1985-05-23
K842983 AMPCO OPTHALMIC TRAY Associated Medical Products Co. HOZ Class II 1985-05-22
K850340 EYE PROCEDURE PACK Marwood Medical, Inc. HOZ Class II 1985-05-22
K844356 SYSTEM 930 ARGON PHOTOCOAGULATOR Coherent Medical Group HQB Class II 1985-05-16
K842601 PRE-OPERATIVE OPHTHALMIC DRESSING TRAY Ophthalmic Resources, Inc. HOZ Class II 1985-05-10
K842990 STERILE EYE SURGERY KITS Biological & Environmental Control Laboratories HOZ Class II 1985-05-09
K842647 CATARACT TRAY Deroyal Industries, Inc. HNN Class I 1985-05-09
K850119 PHARMASEAL EYE PREP TRAY American Pharmaseal Div. Ahsc HNR Class I 1985-05-09
K843276 IOCARE CONVERTER KIT Chiron Vision Corp. HQC Class II 1985-05-09
K851264 AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMAS American Medical Optics HLI Class II 1985-05-01
K851263 AMER. MEDICAL OPTIC MONOCULAR DIRECT OPHTHALMASCOP American Medical Optics HLI Class II 1985-05-01
K851262 AMER. MEDICAL OPTICAL BINOCULAR INDIRECT OPHTHALMA American Medical Optics HLI Class II 1985-04-30
K850572 HGM, INC. MEDICAL LASER ENDOCOAGULATOR MODEL 8-K Hgm, Inc. HQF Class II 1985-04-23
K850050 PMS OPHTHALMOLOGY PACK-PMS EYE TRAY/PACK Professional Medical Services HOZ Class II 1985-04-23
K850532 ATLANTIC OPTICAL SYSTEMS, INC. UNIVERSAL PACK Atlantic Optical Systems, Inc. HQC Class II 1985-04-15
K850149 KCP (KELMAN COMPACT PHACO-EMULSIFIER) PEA CooperVision, Inc. HQC Class II 1985-04-15
K850148 KCP PAK CONVENIENCE PACK CooperVision, Inc. HQC Class II 1985-04-15
K850275 KCP PAK #2 CONVENIENCE PACK MODIFICATION CooperVision, Inc. HQC Class II 1985-04-15
K843594 AIRVIT MODEL 8500 Lasermed Corp. HQE Class II 1985-04-11
K851009 INFUSION SLEEVE - OPHTHALMIC Medical Instrument Development Laboratories, Inc. HQC Class II 1985-04-03
K850578 PHACOEMULSIFICATION TIP Ultramed, Inc. HQC Class II 1985-04-03
K851062 DERAPAGE EYEWEAR BY VITALONI Vitaloni S.P.A. HQY Class I 1985-04-01
K851039 EYEDENTITY EYEWEAR Vitech Research C/O Johnsen, Manfredi & Thorpe HQZ Class I 1985-04-01
K850899 I/A BAC STOP KIT Staar Surgical Co. HQC Class II 1985-03-29
K850900 PHACO-BAC STOP KIT Staar Surgical Co. HQC Class II 1985-03-29
K850991 LANDERS VITRECTOMY LENS RING SYSTEMS Ocular Instruments, Inc. HNH Class I 1985-03-29
K850857 I/A HANDPIECE Medical Instrument Development Laboratories, Inc. HQE Class II 1985-03-29
K850665 CORNEASCOPE MODEL 1200 Kera Corp. HLQ Class I 1985-03-20
K850905 CR-39 TYPE RESIN Orplex Corp. HQG Class I 1985-03-20
K850883 SCLERAL SPONGE II, OLK DESIGN, E5395-10 & E5395-11 Storz Instrument Co. HOZ Class II 1985-03-20
K843487 VISITEC OPHTHALMIC FLUID DISTRIB- SET Visitec Co. HQC Class II 1985-03-13
K850049 KATENA MICROMETER KNIFE W/XTAL BLADE OF CRYSTAL SA Xtal Corp. HNN Class I 1985-03-06
K845039 OPERAID DISPOS. IRRIGATING KNIFE Jedmed Instrument Co. KYG Class I 1985-03-05
K850191 DIGILAB 750 AUTOMATED PERIMETER W/IBM PERSON/COMPU Bio-Rad HPT Class I 1985-03-04
K844971 MONOCULAR DIRECT OPHTHALMOSCOPE Nidek, Inc. HLI Class II 1985-02-15
K843596 NIDEK-BINOCULAR INDIRECT OPHTHALMOSCOPE Nidek, Inc. HLI Class II 1985-02-15
K840204 WHITE OCULAR PRESSURE RELIEF DEVICE Precision-Cosmet Co., Inc. KYF Class II 1985-02-15
K843597 NIDEK MONOCULAR INDIRECT OPHTHALMOSCOPE Nidek, Inc. HLI Class II 1985-02-15
K844409 DTL ELECTRODE Sauquoit Industries, Inc. HLZ Class II 1985-02-14
K843319 CILCO I/A SURGICAL PACK Cilco, Inc. HQC Class II 1985-02-14
K844209 ARGON/KRYPTON LASER SYSTEM 8500 Cooper Lasersonics, Inc. HQB Class II 1985-02-06
K843899 GRC-WT, GRC-W Olympus Corp. HKI Class II 1985-01-28
K844715 VISC-X VITREOUS ASPIRATING & CUTTING INSTRUMENT SY Optical Micro Systems, Inc. HQE Class II 1985-01-22
K844694 TITMUS VISION TESTER II Titmus Optical, Inc. HIT Class I 1985-01-22
K844898 CANON 60 ZOOM FUNDUS CAMERA CF-60ZA OPHTHALMIC CAM Canon USA, Inc. HKI Class II 1985-01-22
K844778 SUNGLASSES B & M Sporting Goods, Inc. HQG Class I 1985-01-04
K844358 SYSTEM 920 PHOTOCOAGULATOR TO INCLUDE SCHIRMERSCOP Coherent Medical Group HQF Class II 1985-01-03
K844668 MODEL 8000 ND:YAG LASER SYS TREATMENT OF BENIGN LE Cooper Lasersonics, Inc. HQF Class II 1985-01-03
K843646 STEINWAY MICRO-KERATO-TREPHINE Steinway Instrument Co., Inc. HRH Class I 1985-01-03
K843702 APPARATUS & METHODS SELF-EXAM OF EYE Wheel Checkers HOQ Class I 1985-01-03
K844716 MAGNIFYING SPECTACLES W/PLASTIC LENSES Gazelle Corp. HOI Class I 1985-01-03
K844364 SKIASCOPIC RACKS Luneau Laboratories HMH Class I 1985-01-02
K844365 COLOR VISION TESTERS Luneau Laboratories HIT Class I 1985-01-02
K844666 SITE ULTRASONIC EMULSIFICATION MODULE OP Chiron Vision Corp. HQC Class II 1984-12-27
K844198 ARGON LASER PHOTOCOAGULATOR SYS REPEAT MODE Nidek, Inc. HQB Class II 1984-12-24
K844761 SCHWARTZ/NORRIS CORNEAL LIGHT SHIELD Medical Instrument Development Laboratories, Inc. HOY Class I 1984-12-24
K844197 ARGON/KRYPTON & KRYPTON LASER PHOTOCOAGULATION SYS Nidek, Inc. HQB Class II 1984-12-24
K844054 CANON AUTO KERATOMETER K-1 Canon USA, Inc. HLI Class II 1984-12-19
K843391 INFUSION ASPIRATION VITRECTOMY SYS Medical Instrument Development Laboratories, Inc. HQE Class II 1984-12-19
K842793 MVS XII Medical Instrument Development Laboratories, Inc. HQE Class II 1984-12-19
K842856 LANDERS-FOULKS TEMP. KERATOPROSTHESIS Ocular Instruments, Inc. MLP Class II 1984-12-18
K844657 SPECTABLE FRAME MAGNIFYING BRILLETTE Pro Design Intl. AS HOJ Class I 1984-12-11
K844658 SPECTABLE FRAME - PRODESIGN SUN CLUB Pro Design Intl. AS HQZ Class I 1984-12-11
K844150 MEDICAL OPTICS PHACOEMULSIFICATION KIT American Medical Optics HQC Class II 1984-12-11
K844553 MICRA DIAMOND KNIFE MICRA ADJUSTABLE KNIFE Codman & Shurtleff, Inc. HNN Class I 1984-12-11
K844374 O.M.S. GUILLOTINE CUTTER Optical Micro Systems, Inc. HQE Class II 1984-12-11
K844362 OPHTHALMIC CHAIR Luneau Laboratories HMF Class I 1984-12-11
K842188 MULTIPLE-LENS, SPECTACLES, CUSTOM Gold Cadillac Co. HQE Class II 1984-12-11
K842189 MULTIPLE LENS, SPECTACLES CUSTOM Hanmy Optical Industrial Co. HQG Class I 1984-12-11
K843812 WOODLYN CLASSIC CATARACT ACUITY TEST Woodlyn, Inc. HLI Class II 1984-12-11
K842187 MULTIPLE LENS, SPECTACLES, CUSTOM Pavuna , Ltd. HQG Class I 1984-12-11
K842945 COOPERVISION SYSTEM VI CooperVision, Inc. HQC Class II 1984-12-11
K844510 OMS SCISSORS Optical Micro Systems, Inc. HQE Class II 1984-12-11
K844570 QUANTUM 412 Keta Corp. HPT Class I 1984-12-05
K844363 OPHTHALMIC STAND Luneau Laboratories HMF Class I 1984-12-05
K844038 VISITEC MAGNIFYING SPECTACLES Visitec Co. HOI Class I 1984-11-29
K843961 COLOR OPTIC CORNEAL EYE SHIELD Colors IN Optics , Ltd. HOY Class I 1984-11-28
K844321 CUSTOM LITE Buchmann Optical Industries HQG Class I 1984-11-27
K843386 MENDEZ U/S CYSTOTOME CooperVision, Inc. HQC Class II 1984-11-27
K842979 CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA CooperVision, Inc. HQC Class II 1984-11-27
K843897 POCKET OPHTHALMOSCOPE GH Design Med. Corp. HLJ Class II 1984-11-27
K843277 IOCARE PHACOEMULSIFICATION PACK Chiron Vision Corp. HQC Class II 1984-11-27
K843275 IOCARE IRRIGATION/ASPIRATION PACK Chiron Vision Corp. HQC Class II 1984-11-27
K843278 IOCARE ULTRASONIC TITANIUM TIPS Chiron Vision Corp. HQC Class II 1984-11-27
K842471 AUTOMATED INTRAOCULAR SCISSORS Medical Instrument Development Laboratories, Inc. HQE Class II 1984-11-21
K843992 CILCOR OPHTHALMIC INSTRUMENTS Cilco, Inc. HNR Class I 1984-11-21

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