meddevicedb.com FDA Device Reference

Review Panel

Ophthalmic FDA 510(k) Clearances & Devices

Cleared Devices
4,756
Product Codes (page)
51
Latest Decision
1984-11-21

Clearances · page 43 of 48

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K842835 BRILLETTE MODEL Cillus Company, Inc. HOI Class I 1984-11-21
K843096 CRISTY/COTE Titmus Optical, Inc. HQG Class I 1984-11-21
K844129 SHURE GRIP TYING FORCEPS Mentor O & O, Inc. HNR Class I 1984-11-21
K843099 MAMIYA SLIT LAMP P-1 Okada Corp. HLI Class II 1984-11-21
K841721 OPERAID SURGICAL DRAIN Jedmed Instrument Co. HOZ Class II 1984-11-21
K843039 SITE ANTERIOR CAPSULOTOMER Chiron Vision Corp. HMX Class I 1984-11-21
K841807 OPERAID NUCLEUS Jedmed Instrument Co. KYG Class I 1984-11-21
K843304 BINOCULAR INDIRECT OPHTHALMOSCOPE Mentor O & O, Inc. HLI Class II 1984-11-21
K843041 HESLIN DISPOS. TUBING SET Innovative Surgical Products, Inc. HQE Class II 1984-11-21
K843354 EPISCLERAL VENOUS PRESSURE Eyetech, LLC HKX Class II 1984-11-19
K841730 BAILEY LENS SHOOTER Intermedics Intraocular, Inc. KYB Class I 1984-11-19
K843966 ARGON/KRYPTON LASER PHOTOCOAGULATOR SYS American Medical Optics HQB Class II 1984-11-08
K843965 ARGON LASER PHOTOCOAGULATOR SYS American Medical Optics HQF Class II 1984-11-06
K842410 AMER. EDWARDS LAB FLEXISCOPE American Edwards Laboratories HRK Class I 1984-11-05
K840834 CORNEAL LIGHT SHIELD Gabl, Inc. HOY Class I 1984-10-05
K843042 VISION TESTER Stereo Optical Co., Inc. HKO Class I 1984-10-05
K843491 CONCEPT FIBER OPTIC CANALICULUS INTUBA Concept, Inc. HNL Class I 1984-10-05
K841861 CANON AUTOREF R-10 Canon USA, Inc. HKO Class I 1984-10-05
K840181 CATAREX/ULTRASONICS KIT Calliope Corp. HQC Class II 1984-10-05
K841738 AMER. SURGICAL CORP. EXTRA PLUS PAK American Surgical Co., Inc. HQE Class II 1984-10-05
K843195 VISITEC FLIERINGA-LEGRAND FIXATION RING Visitec Co. HMH Class I 1984-10-05
K843095 TRIA LENS SET Optek Medico Co., Ltd. HPC Class I 1984-10-05
K840063 CATAREX VITRECUTTER I/A DISPOS. CUT Calliope Corp. HQC Class II 1984-10-05
K843196 VISITEC EYE SPECULUM Visitec Co. HNC Class I 1984-10-05
K842859 MICROSCOPE MITTS SUPPORT TRAY COVER Chiron Vision Corp. HJO Class II 1984-10-05
K843021 CANON 60 FUNDUS CAMERA CF-60U Canon USA, Inc. HKI Class II 1984-10-05
K843447 CILCO DIAMOND KNIFE Cilco, Inc. HNN Class I 1984-10-05
K843048 RING SUPPORTED TREPHINE FOR CORNEA TRANS Precision Instruments, Inc. HRH Class I 1984-10-05
K843123 FRAME SPECTACLE Vision Industries Corp. HQZ Class I 1984-10-05
K842892 NIDEK DIGITAL KERATOMETER Nidek, Inc. HQL Class III 1984-10-05
K842504 AMER. MEDICAL OPTICS DIGITAL KERATO- American Medical Optics HQL Class III 1984-10-01
K842197 AMERICAN MEDICAL OPTICS I/A KIT- IRRIG American Medical Optics HQE Class II 1984-10-01
K841294 ACU220 CRYO UNIT Keller Instruments, Inc. HQA Class II 1984-08-15
K842251 AMERI. MEDICAL OPTICS ARGON LASER PHOTO American Medical Optics HQF Class II 1984-08-15
K842250 AMER. MEDICAL OPTICS ARGON/KRYPTON LASE American Medical Optics HQF Class II 1984-08-15
K842458 SITE SIMCOE STYLE I/A HANDPIECE Chiron Vision Corp. HQC Class II 1984-08-15
K840414 COLOR OPTIC CORNEAL EYE SHIELD Diversations, Inc. HOY Class I 1984-08-15
K842567 PORTABLE ACUIOMETER Randwal Instrument Co., Inc. HLJ Class II 1984-08-15
K841764 WOODLYN CLASSIC JAVAL OPHTHALMOMETER Woodlyn, Inc. HLI Class II 1984-08-07
K841761 WOODLYN CLASSIC SLIT LAMP HSSL-CL Woodlyn, Inc. HLI Class II 1984-08-07
K841767 WOODLYN CLASSIC KERATOMETER Woodlyn, Inc. HLI Class II 1984-08-07
K842697 ROOTMAN ORBITAL SURGERY INSTRUMENT SET Downs Surgical , Ltd. HNR Class I 1984-08-07
K842128 AMERICAN MEDICAL OPTICS PHOTOKERATO American Medical Optics HJA Class I 1984-08-07
K841765 WOODLYN STANDARD SLIT LAMP HSSL-ST Woodlyn, Inc. HLQ Class I 1984-08-07
K841762 WOODLYN APPLANATION TONOMETER Woodlyn, Inc. HKX Class II 1984-08-02
K841763 WOODLYN SLIT LAMP HSSL-EC Woodlyn, Inc. HLI Class II 1984-08-02
K841248 SUNGLASSES China Toy & Novelty Co., Ltd. HQG Class I 1984-07-27
K840840 GENERATED RETINAL REFLEX IMAGERY SYS Electro Optical Instruments HKM Class I 1984-07-12
K842412 MODEL 4000 MD-YAG LASER FOR MALIGNANT Cooper Lasersonics, Inc. HQF Class II 1984-06-26
K834155 UNIVERSAL PACK Atlantic Optical Systems, Inc. HQE Class II 1984-06-19
K840836 CAT 100 CooperVision, Inc. HKX Class II 1984-06-19
K840495 MANUAL IRRIGATING/ASPIRATING UNIT Alltek, Inc. HQC Class II 1984-06-19
K841099 OCTOPUS 500/500E Cilco, Inc. HPT Class I 1984-06-19
K841855 AMER. MED. OPTICS ARGON LASER PHOTO American Medical Optics HQF Class II 1984-06-19
K842045 WOODLYN CLASSIC EXAM. CHAIR Woodlyn, Inc. HME Class I 1984-06-19
K841760 WOODLYN CLASSIC INSTRUMENT STAND Woodlyn, Inc. HRJ Class I 1984-06-19
K840692 CONTACT LENS CASE FOR SOFT LENSES Optimum Manufacturers, Inc. LRX Class II 1984-06-07
K841856 AMER. MED. OPTICS ARGON/KRYPTON LASER American Medical Optics HQF Class II 1984-06-07
K841908 SPECTACLE FRAMES Cosmas Optical USA , Ltd. HQZ Class I 1984-06-07
K841515 SCANLAN VASCU-STATT II Scanlan Intl., Inc. HRG Class I 1984-06-05
K841766 WOODLYN CLASSIC TRIAL LENS SET Woodlyn, Inc. HPC Class I 1984-06-01
K841768 WOODLYN LIGHTWEIGHT TRIAL FRAME Woodlyn, Inc. HPA Class I 1984-06-01
K841951 MICROSURGICAL KNIFE ETHICON, Inc. HNN Class I 1984-06-01
K840115 SWISS OPTICAL PRODUCTS-CONTACT CASE Moonbeam International, Inc. HQD Class II 1984-06-01
K841163 CONTACT LENS INSERTER/REMOVER Optimum Manufacturers, Inc. HQD Class II 1984-06-01
K841759 OPHTHALMIC TABLE Woodlyn, Inc. HMG Class I 1984-06-01
K840695 PHACOEMULSIFICATION KITS Innovative Surgical Products, Inc. HQC Class II 1984-05-22
K841794 SUNGLASSES Whole Sale Importers HQY Class I 1984-05-22
K840693 DISPOSABLE SCLERAL GLOBE PLUG Innovative Surgical Products, Inc. LXP Class II 1984-05-22
K841599 STORZ UNIVERSAL EYE SHIELD Storz Instrument Co. HOY Class I 1984-05-22
K840691 CONTACT LENS CASE FOR RIGID GAS PERMA Optimum Manufacturers, Inc. LRX Class II 1984-05-18
K841101 CLAYMAN-PAREL CAPSULE COUPEUR Miami Eye Technology, Inc. HNY Class I 1984-05-16
K840425 OPTHERM FINE TIP Suncoast Medical Manufacturers, Inc. HQP Class II 1984-05-09
K840855 CORNEAL SCLERAL LANCE Sharpoint, Inc. HNN Class I 1984-05-09
K840694 LENS INSERTION GLIDE Innovative Surgical Products, Inc. KYB Class I 1984-05-09
K841007 OPHTHALMIC CURETTE-VARIOUS Premier Dental Products Co. HNZ Class I 1984-05-09
K841293 PANORAMIC LOUPES - VARIOUS Keller Instruments, Inc. HLT Class II 1984-05-09
K840861 TSE-ANDERSON MODIFIED LACRIMAL GROOV Hansen Ophthalmic Development Lab HNL Class I 1984-05-09
K841292 SPECTACLE INDIRECT OPHTHALMOSCOPE Keller Instruments, Inc. HLJ Class II 1984-05-09
K840426 OPTHERM EXTRA FINE TIP Suncoast Medical Manufacturers, Inc. HQP Class II 1984-05-09
K841326 REPLACE-A-TIP RECHARGEABLE HIGH TEMP Suncoast Medical Manufacturers, Inc. HQP Class II 1984-05-09
K840590 FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE Hgm, Inc. HQF Class II 1984-05-09
K841002 LACHRYMAL PROBES-VARIOUS Premier Dental Products Co. HNW Class I 1984-05-09
K833747 GALLIE CRYONUCLEATOR Mono Research Laboratories HPS Class II 1984-05-09
K841325 REPLACE-A-TIP RECHARG. LOW TEMP. Suncoast Medical Manufacturers, Inc. HQP Class II 1984-05-09
K840965 SITE COAXIAL I/A HANDPIECE 30 TIP Chiron Vision Corp. HQC Class II 1984-05-09
K840145 MONITOR CO2 LASER SURGICAL SYSTEM Cooper Lasersonics, Inc. HQF Class II 1984-04-25
K840104 PETRUS IOL GUIDE Precision-Cosmet Co., Inc. KYB Class I 1984-04-24
K840255 VISTECH VCTS 6000 Vistech Consultants, Inc. HOX Class I 1984-04-13
K840475 CYSTOTOME, 140-S Cilco, Inc. HNY Class I 1984-04-05
K834340 IOCARE IRRIGATION & ASPIRATION PACK Chiron Vision Corp. HQC Class II 1984-04-05
K834610 LASER LENS-VARIOUS MODELS Meditec of America HQF Class II 1984-04-05
K840854 MEDICAL LASER ENDOCOAGULATOR 5K Hgm, Inc. HQF Class II 1984-04-02
K833259 MULTIPLE Sun House Products Co. HQG Class I 1984-04-02
K834437 KEATES IRRIGATION/ASPIRATION/VITREOUS Frigitronics of Connecticut, Inc. HQE Class II 1984-03-30
K841072 IRRIGATION, ASPIRATION TUBING SETS Innovative Surgical Products, Inc. HQC Class II 1984-03-29
K840207 DOUBLE & SINGLE TANTALUM CLIPS Storz Instrument Co. HQW Class II 1984-03-29
K833669 IMAGE DEFLECTOR Michael Onufryk HPA Class I 1984-03-27
K840004 WEE BAG O'MERCURY Surgi-Quip Inc.U LCC Class II 1984-03-22
K834354 OPHTEC RUST RING REMOVER Jedmed Instrument Co. HOG Class I 1984-03-19

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