meddevicedb.com FDA Device Reference

Review Panel

Ophthalmic FDA 510(k) Clearances & Devices

Cleared Devices
4,756
Product Codes (page)
47
Latest Decision
1987-02-20

Clearances · page 39 of 48

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K870194 UNITED SURGICAL CORP. DIATHERMIC PLUS United Surgical Corp. HQR Class II 1987-02-20
K870278 CONTACT LENS CASE W/POSTIVE HEAT INDI. MOD. #695 Ryder Intl. Corp. LPN Class II 1987-02-20
K870439 LOOK IRRIGATING CYSTOTOMES Look, Inc. HNY Class I 1987-02-20
K870195 UNITED SURGICAL CORP. CRYOPTIC PLUS United Surgical Corp. HPS Class II 1987-02-20
K870120 DIGILAB MODEL 1500 PERIMETER Bio-Rad HPT Class I 1987-02-20
K870437 LOOK CAPSULE POLISHERS/SCRAPERS Look, Inc. HNZ Class I 1987-02-20
K870441 LOOK CORTEX EXTRACTORS Look, Inc. HMX Class I 1987-02-20
K870438 LOOK IRRIGATING CANNULAS Look, Inc. HMX Class I 1987-02-20
K870121 DIGILAB MICRO ONE APPLANATION TONOMETER Bio-Rad HKX Class II 1987-02-20
K870112 STORZ ENT/OPHTHALMIC MAXI CHAIR Storz Instrument Co. HME Class I 1987-02-12
K870072 SUMMIT OPTICS CONTACT LENS REMOVER Dayton Mfg. Co. KYE Class I 1987-02-12
K870068 ASPIRATION REVERSAL CONTROL (ARC) MODULE Optical Micro Systems, Inc. HQE Class II 1987-02-12
K864959 OBF MODEL 112 VACUUM CUP SYSTEM Ocular Blood Flow Laboratories, Inc. HKX Class II 1987-02-12
K870203 KEELER LVA SYSTEM MULTI-CAP SERIES LVA51-1/2/3/4/5 Keeler Instruments, Inc. HKK Class I 1987-02-12
K870164 SUMMIT OPTICS SOFT CONTACT LENS CASE Dayton Mfg. Co. LRX Class II 1987-02-10
K865103 KROM-X LENS SYSTEM Neo Optics, Inc. HQG Class I 1987-01-20
K863886 SPORTLIFE SUNWEAR North American Vacuum Coating Co. HQY Class I 1987-01-20
K864594 DUALENZ LOW VISION EYEWEAR Global Eye Care, Inc. HKK Class I 1987-01-20
K864726 I/A/KPE TIP Ipax, Inc. HQC Class II 1987-01-20
K864502 THE CONTACT LENS ASSIST BRUSH Young and Moore Enterprises, Inc. LPN Class II 1987-01-20
K864520 BARRON ROTARY BLADE TREPHINE USING HESSBURG-BARRON Precision Instruments, Inc. HRH Class I 1987-01-20
K863429 MODIFIED DEVICE FOR SELF EXAMINATION OF EYES Wheel Checkers HOQ Class I 1987-01-20
K862315 FYODOROV COLLAGEN CORNEAL SHIELD Medical Technology Development Corp. MOE Class I 1987-01-07
K864639 REUSABLE SURGICAL KERATOSCOPE Jedmed Instrument Co. HLR Class I 1986-12-29
K863970 MLC ENDOTHELIAL CELL COUNTER Mlc Technologies HJO Class II 1986-12-29
K864292 DISPOSAL SURGICAL INSTRUMENTS FOR OPHTHALMOLOGY Eye-Ko, Inc. HNQ Class I 1986-12-29
K864494 MODEL 6500 OPTHALMIC CHAIR Koken Mfg Company, Inc. HME Class I 1986-12-15
K864301 SITE PHACOEMULSIFICATION SYST/OPHTHALMIC USE (MOD) Site Microsurgical Systems, Inc. HQC Class II 1986-12-15
K864574 MAC 150E OPTHALMIC CHAIR Koken Mfg Company, Inc. HME Class I 1986-12-15
K864035 VES-10 INTRAOCULAR SCISSORS DRIVE Trek Medical Products, Inc. HQE Class II 1986-12-15
K864290 RK-M & RK-DK DIAMOND KNIVES WITH MEASURING GAUGE Keeler Instruments, Inc. HNN Class I 1986-12-15
K864369 LTS CORNEAL MICROSCOPE LASER TOMOGRAPHIC SCANNER Heidelberg Instruments HJB Class I 1986-12-15
K864304 YANNUZZI FUNDUS LASER LENS Ocular Instruments, Inc. HJK Class II 1986-12-15
K864467 HENSON - HAMBLIN CFS 2000 CENTRAL FIELD SCREEN Keeler Instruments, Inc. HOO Class I 1986-12-15
K864065 BKS-42 DISPOSABLE VACUUM TUBING PACK Allergan, Inc. HNO Class I 1986-12-15
K863911 MAINSTER RETINA LASER LENS Ocular Instruments, Inc. HJK Class II 1986-12-12
K864012 IRAS PERIMETER Randwal Instrument Co., Inc. HPJ Class II 1986-12-12
K864183 OPHTHALMIC SURGICAL INSTRUMENTS Techno Ophthalmics Intl. HNR Class I 1986-11-28
K864266 OPHTHALMIC KNIFE & FORCEPS Western Medical Products, Inc. HNR Class I 1986-11-28
K864418 LANDERS INDIRECT VITRECTOMY LENS Ocular Instruments, Inc. HJK Class II 1986-11-28
K864399 FISHER PRICE SUNJAMMERS Fisher Price HQY Class I 1986-11-21
K864157 OPTI-BRUSH Willmar Contact Lens Clinic LPN Class II 1986-11-13
K864063 ORION 3001, LASER PHOTOCOAGULATOR G. Rodenstock Instrumente GmbH HQF Class II 1986-11-13
K864071 FAULKNER FORCEPS Staar Surgical Co. HNR Class I 1986-11-13
K864037 KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZER Kera Corp. HJB Class I 1986-11-13
K863509 OPTEC 1000 DMV Stereo Optical Co., Inc. HOX Class I 1986-11-10
K863983 EXETER OPERATING LOUPE Exeter Instruments, Inc. HJH Class I 1986-11-10
K863988 THORTON TITANIUM HOOK ANGLED RIGHT Keeler Instruments, Inc. HNQ Class I 1986-10-31
K863991 THORTON TITANIUM NEEDLEHOLDERS(NO,W CATCH & STAND Keeler Instruments, Inc. HNR Class I 1986-10-31
K864056 GRIESHABER AIR SYSTEM/PRESSURE OPHTHALMIC IRRIGANT Grieshaber & Co. HQC Class II 1986-10-31
K863727 FIXATION INSTRUMENTS Medical Technology Development Corp. HNR Class I 1986-10-31
K863728 THE ERGOSYSTEM CHAIR Charles D. Bell, Inc. HME Class I 1986-10-31
K863989 THORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER) Keeler Instruments, Inc. HNC Class I 1986-10-31
K863990 THORNTON TITANIUM SILVER SPATULA Keeler Instruments, Inc. HND Class I 1986-10-31
K863992 THORNTON TITANIUM FORCEPS (VARIOUS TYPES) Keeler Instruments, Inc. HNR Class I 1986-10-31
K863725 CATARACT DIAMOND KNIFE Medical Technology Development Corp. HNN Class I 1986-10-31
K864003 PACO-FOLDER (TM) INTRAOCULAR LENS FORCEPS Allergan, Inc. HNR Class I 1986-10-31
K863993 VTS REPORTER OR VTS LINK Sensory Aids Corp. HPF Class I 1986-10-31
K863994 VIEWSCAN Sensory Aids Corp. HOT Class I 1986-10-31
K863444 GRIESHABER GLOBAL CONTROL TUBING SET Grieshaber & Co. HQC Class II 1986-10-31
K863246 MIRALITE Mira, Inc. HQF Class II 1986-10-31
K860953 SUNGLASSES (NON-PRESCRIPTION) Roseburg SA HQY Class I 1986-10-24
K862977 MEDITRADE ARTIFICIAL EYES AND IMPLANTS Meditrade, Inc. HPZ Class II 1986-10-20
K863663 OPHTHALMIC SURGICAL OCULAR MARKERS Myocure, Inc. HMR Class I 1986-10-20
K863775 RK VACUUM FIXATION RING SYSTEM Ameritek, Inc. HNH Class I 1986-10-20
K863862 MILITARY PRESCRIPTION FRAME Halo Optical Products, Inc. HQZ Class I 1986-10-20
K843511 BAUSCH & LOMB CLEANING PAD Bausch & Lomb, Inc. LPN Class II 1986-10-16
K863591 ENDOPHOTOCOAGULATION PROBE Mira, Inc. HQF Class II 1986-10-10
K863651 POLAREX AND POLAREX MLD Selex, Inc. HQY Class I 1986-10-10
K863729 OPHTHALMIC FITLER MICRO CAPSULE Ipax, Inc. HQC Class II 1986-10-10
K862568 LDS - LASER DELIVERY SYSTEM Coherent Medical Group HQF Class II 1986-10-07
K863367 FORMALENS 2000 Vision-Sciences, Inc. HQG Class I 1986-09-26
K863665 THE ULTIMATE Myocure, Inc. HNN Class I 1986-09-25
K863235 SURGICAL IOP MONITOR Ameritek, Inc. HKX Class II 1986-09-25
K863664 OPHTHALMIC SURGICAL SPECULUM Myocure, Inc. HNC Class I 1986-09-25
K862987 MODEL 1000 OPHTHALMIC LASER SYSTEM CooperVision, Inc. HQF Class II 1986-09-24
K863474 KASEY EYE SHIELD Kasey Enterprises, Inc. HOY Class I 1986-09-24
K863217 DIGILAB MODULAR ONE-APPLANATION TONOMETER Bio-Rad HKX Class II 1986-09-24
K863008 -OM WEST 2000 GNATUS CHAIR Sds Dental, Inc. HME Class I 1986-09-24
K863209 US PLUS-PAK(R) SURGICAL SYSTEM Ipax, Inc. HQC Class II 1986-09-08
K863048 OPM SLIT LAMP MODEL P-1 & MODEL P-3 Optek Medico Co., Ltd. HJO Class II 1986-09-03
K863125 EVE COLLECTION (EYEGLASS FRAME) Precision Lens Crafters HQZ Class I 1986-09-03
K863200 COMPUTON(R) Optical Radiation Corp. HKX Class II 1986-09-03
K863182 EYE BARRIER O.R. Concepts, Inc. HQZ Class I 1986-09-03
K862338 SENSORY 6 Brytech, Inc. HPG Class I 1986-09-03
K862379 CORNEAL MODELING SYSTEM Computed Anatomy, Inc. HJO Class II 1986-08-25
K862323 CANON NON-MYDRIATIC RETINAL CAMERA CR4-45NM Canon USA, Inc. HKI Class II 1986-08-21
K862869 PETRUS SINGLE MIRROR LASER LENS Ocular Instruments, Inc. LQJ Class II 1986-08-21
K862728 HOSKINS NYLON SUTURE LASER LENS Ocular Instruments, Inc. HJK Class II 1986-08-21
K861747 KEELER FIBEROPTIC HEADLAMP Keeler Instruments, Inc. HPQ Class II 1986-08-21
K863027 SCHIRMER PERIPHERAL IRIDECTOMY LASER LENS Ocular Instruments, Inc. HJK Class II 1986-08-21
K862943 SITE DISPOSABLE FIBEROPTIC ILLUMINATOR AND CABLE Site Microsurgical Systems, Inc. HQE Class II 1986-08-21
K862713 ABRAHAM IRIDECTOMY LENS (YAG LASER) Ocular Instruments, Inc. HKS Class I 1986-08-21
K862719 SOLARSHIELDS Dioptics HQY Class I 1986-08-21
K862868 ABRAHAM YAG LASER LENS Ocular Instruments, Inc. HJK Class II 1986-08-21
K861746 KEELER DUAL LIGHTSOURCE Keeler Instruments, Inc. HPQ Class II 1986-08-21
K862692 KARICKHOFF DIAGNOSTIC/LASER LENS Ocular Instruments, Inc. HKS Class I 1986-08-21
K862188 IRRIGATION & ASPIRATION/VITRECTOMY DEVICE Coburn Optical Ind., Inc. HQE Class II 1986-08-21
K862517 BAUSCH & LOMB CONTACT LENS VIEWER Bausch & Lomb, Inc. HLF Class I 1986-08-11
K862524 DEKNATEL (R) TREPHINE Deknatel, Inc. HRH Class I 1986-08-11

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