meddevicedb.com FDA Device Reference

Review Panel

Ophthalmic FDA 510(k) Clearances & Devices

Cleared Devices
4,756
Product Codes (page)
37
Latest Decision
1986-08-11

Clearances · page 40 of 48

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K862518 BAUSCH & LOMB VERTOMETER V-5 Bausch & Lomb, Inc. HLM Class I 1986-08-11
K862524 DEKNATEL (R) TREPHINE Deknatel, Inc. HRH Class I 1986-08-11
K862709 MECHANICAL CYSTITOME Rudolph Beaver, Inc. HNY Class I 1986-08-01
K862519 BAUSCH & LOMB ACCU-CHART 3 ACUITY PROJECTOR Bausch & Lomb, Inc. HOS Class I 1986-07-23
K862578 TECHNA VISION CASTING RESIN Techna Vision HQG Class I 1986-07-23
K862137 NIDEK KM-1000 SURGICAL KERATOMETER Nidek, Inc. HLQ Class I 1986-07-23
K861380 SERIES TEN THOUSAND MASTER CooperVision, Inc. HQE Class II 1986-07-11
K862515 BAUSCH & LOMB CSL-1000 SLIT LAMP Bausch & Lomb, Inc. HJO Class II 1986-07-11
K861854 OPM SLIT LAMP MODEL P-1 Optek Medico Co., Ltd. HJO Class II 1986-07-11
K862024 SUSSMAN FOUR MIRROR HAND HELD GONIOPRISM Ocular Instruments, Inc. HKS Class I 1986-07-11
K862343 VACUUM HANDLE MODEL I/A - 1 Cutler Medical Instruments HQE Class II 1986-07-11
K862521 BAUSCH & LOMB GR-3 REFRACTOR Bausch & Lomb, Inc. HKO Class I 1986-07-11
K862502 MASUNAGA OPTICAL MANUFACTURING South West Intl., Inc. HQZ Class I 1986-07-11
K862512 RITCH TRABECULOPLASTY LASER LENS Ocular Instruments, Inc. HKS Class I 1986-07-11
K862516 BAUSCH & LOMB OSL-2000 SLIT LAMP Bausch & Lomb, Inc. HJO Class II 1986-07-11
K862503 KOELN OPTIK South West Intl., Inc. HQZ Class I 1986-07-11
K861565 SERIES TEN THOUSAND COMPACT CooperVision, Inc. HQE Class II 1986-07-11
K862520 BAUSCH & LOMB PSL-3000 SLIT LAMP Bausch & Lomb, Inc. HJO Class II 1986-07-11
K862021 PHACOEMULSIFICATION ULTRASONIC FRAGMENT SYSTEM Ultramed, Inc. HQC Class II 1986-06-23
K862063 ENTRAVISION MODECO II I/A MACHINE & I/A HANDPIECE Entravision, Inc. HQC Class II 1986-06-19
K861648 WISE IRIDOTOMY-SPINCTEROTOMY LENS Ocular Instruments, Inc. HJK Class II 1986-06-19
K862064 ENTRAVISION EP-500 I/A ECCO PACK Entravision, Inc. HQC Class II 1986-06-19
K862094 LENS-EZE Insight International, Inc. HJK Class II 1986-06-19
K862070 INTER-SHARP Intermedics Intraocular, Inc. HNW Class I 1986-06-17
K861990 SOFT LENS FOLDER Staar Surgical Co. KYB Class I 1986-06-17
K862004 ZEISS 30 SL-L Carl Zeiss, Inc. HJO Class II 1986-06-17
K861927 CHILDREN'S SUNGLASSES Jestroy, Ltd. HQY Class I 1986-06-17
K861021 GOTTEX SUNGLASSES Private Eyes Sunglass Corp. HQG Class I 1986-06-17
K861684 SEIKO P-2 & SEIKO P-3 (SPECTACLE LENS) Seiko Optical Products of America, Inc. HQG Class I 1986-06-09
K861744 SAPPHIRE KNIFE BLADE Keeler Instruments, Inc. HNN Class I 1986-06-09
K861825 CORNEAL TRANSPLANT TREPHINE DISPOSABLE BLADE Storz Instrument Co. HRH Class I 1986-06-09
K861162 LENS SPECTACLE NON-CUSTOM (PRESCRIPTION) Efop HQG Class I 1986-06-09
K861960 ZIMLITE LENS Asahi Optical Co. C/O Rosati Associates, P.C. HQG Class I 1986-06-09
K861759 GIRARD SUNGLASSES (NON-PRESCRIPTION) H. Girard S.A. HQG Class I 1986-06-09
K860957 DISPOSABLE ACCESSORIES FOR I/A SYS. & VITEOUS CUT. Medical Corp. of America HQC Class II 1986-06-02
K861748 RUBY & SAPPHIRE BLADE HOLDER Keeler Instruments, Inc. HNN Class I 1986-06-02
K860956 KANSAS I/A SYSTEM & KANSAS I/A & VITRECTROMY SYST. Medical Corp. of America HQC Class II 1986-06-02
K861545 IRRIGATION/ASPIRATION CANNULAS, VARIOUS SIZES Rophae Lens Co., Inc. HMX Class I 1986-05-28
K861732 STORZ E9050 & E9055 DIAMOND KNIVES Storz Instrument Co. HNN Class I 1986-05-28
K861491 ROPHAE DIAMOND KNIFE Rophae Lens Co., Inc. HNN Class I 1986-05-28
K861085 ELASTIC LENS INJECTOR TM Staar Surgical Co. KYB Class I 1986-05-28
K861535 OPTICAL MARKERS/FIXATION RING/CANNU & IRRIGA CANNU CooperVision, Inc. HMR Class I 1986-05-14
K861416 CANON AUTO ACUITOMETER CV-10 Canon USA, Inc. HOX Class I 1986-05-14
K861060 SITE PHACO DISPOSABLE CASSETTE Site Microsurgical Systems, Inc. HQC Class II 1986-05-06
K860989 SITE DISPOSABLE CASSETTE Microsurgical Systems, Inc. HQC Class II 1986-05-06
K861027 KETA HAND-HELD TONOMETER Keta Corp. HKS Class I 1986-05-06
K861334 CILCO DIAMOND KNIVES & DIAMOND KNIFE LINEAR GAUGE Cilco, Inc. HNN Class I 1986-05-02
K861203 MULTI-SPIKE Surgeon Surgical Instrumentation, Inc. KYG Class I 1986-04-28
K861141 MANUAL OPHTHALMIC SURGICAL INSTRUMENTS CooperVision, Inc. HNR Class I 1986-04-24
K861057 MANUAL OPHTHALMIC SURGICAL INSTRUMENTS Precision-Cosmet Co., Inc. HNR Class I 1986-04-24
K860891 AIVUS (7000), ASPIRATION AND IRRIGATION DEVICE Intra-Optics Labs. C/O Newman Assoc. HQE Class II 1986-04-21
K860770 AM-100 I/A AMPAC Dravon Medical, Inc. HQC Class II 1986-04-21
K860794 WRAPPERS, SUNGLASSES Mhci Corp. HQG Class I 1986-04-21
K860642 PHOTRON VISUAL FIELD ANALYZER Biosan Laboratories, Inc. HOM Class I 1986-04-15
K860915 STORZ/MAZZACCO LENS FORCEP Storz Instrument Co. HNR Class I 1986-04-15
K861064 LM-850 AUTOMATIC LENSMETER Nidek, Inc. HLM Class I 1986-04-15
K861065 AR-1100 AUTOMATIC REFRACTOR Nidek, Inc. HKO Class I 1986-04-09
K860544 BACSTOP FILTER IRRIGATION SUPPLY KIT Staar Surgical Co. KYG Class I 1986-04-04
K861063 NIDEK KM-800 AUTO KERATOMETER Nidek, Inc. HLQ Class I 1986-04-04
K861066 AR-1000 AUTOMATIC REFRACTOR Nidek, Inc. HKO Class I 1986-04-04
K860174 GUNKEL CHROMAGRAPH COLOR VISION TESTER Chromagraphics, Inc. HIW Class I 1986-04-04
K861062 AR-1600 AUTOMATIC REFRACTOR Nidek, Inc. HKO Class I 1986-04-04
K855105 SIMMONS SHELL Mira, Inc. HQT Class II 1986-03-31
K861013 ELECTRICALLY CONTROLLED I.V. POLE (OPTHALMIC) Ameritek, Inc. KYG Class I 1986-03-31
K860954 SPECTACLES FRAME Roseburg SA HQZ Class I 1986-03-31
K860960 RARE EARTH INTRA-OCULAR MAGNET Ameritek, Inc. HPN Class I 1986-03-31
K860955 SPECTACLES LENS Roseburg SA HQG Class I 1986-03-31
K860744 OPTHALMIC SURGICAL INSTRUMENTS Tridak Division of Indicon, Inc. HMX Class I 1986-03-31
K860852 SAPPHIRE BLADE SURGICAL KNIFE Med-Tech Develoment Corp. HNN Class I 1986-03-28
K860648 BARRON TWIN BLADE TREPHINE FOR EPPIKARATOPHAKIA Precision Instruments, Inc. HRH Class I 1986-03-25
K860358 FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE (STERILE) Hgm, Inc. HQF Class II 1986-03-21
K860148 MAZZOCCO/FRENCHIK FOLDER Staar Surgical Co. KYB Class I 1986-03-21
K854869 INTRAOCULAR FORCEPS & SCISSORS Mira, Inc. HNR Class I 1986-03-05
K855050 STORZ E9040 & E9046 DIAMOND KNIVES Storz Instrument Co. HNN Class I 1986-03-05
K860014 SYSTEMS PLUS United Surgical Corp. HQE Class II 1986-03-05
K860115 DIGILAB CAMBRIDGE PERIMETER Bio-Rad HOO Class I 1986-02-27
K855170 CANON NON-MYDRIATIC RETINAL CAMERA CR3-45NM Canon USA, Inc. HKI Class II 1986-02-27
K854870 INTRAOCULAR ELECTROMAGNET Mira, Inc. HPO Class II 1986-02-19
K854793 MONOPOLAR INJECTION NEEDLE ELECTRODE Oculinum, Inc. HLW Class II 1986-02-18
K860332 DIAMOND BLADE MICROMETER KNIFE Med-Tech Develoment Corp. HNN Class I 1986-02-13
K860330 MAKLAKOV STYLE TONOMETER Med-Tech Develoment Corp. HKY Class II 1986-02-12
K860331 DISPOSABLE SURGICAL KNIFE Med-Tech Develoment Corp. HNN Class I 1986-02-12
K860305 BEAVER MICRO-GEM GAUGE BLOCK Rudolph Beaver, Inc. HNN Class I 1986-02-12
K853727 KESTREL CONTACT LENS STORAGE CASE(POLYSULFONE) Ryder Intl. Corp. LRX Class II 1986-02-07
K854506 STORZ MVS 2.5MM/4.0MM,6.0MM INFUSION CANNULA Storz Instrument Co. HMX Class I 1986-02-07
K860043 WINK-EASE DISPOSABLE PROTECTIVE Eye Pro Medical Products, Inc. HQY Class I 1986-02-07
K854507 STORZ MVS 19 & 20 GAUGE SCLERAL PLUGS Storz Instrument Co. LXP Class II 1986-02-07
K854868 I/A - VFE SYSTEM II Mira, Inc. HQE Class II 1986-02-07
K860011 NIDEK AC-2000 LASER SYSTEM Nidek, Inc. HQB Class II 1986-02-07
K854871 MICRO SURGICAL SYSTEM Mira, Inc. HQE Class II 1986-02-07
K834162 VIT PAC American Surgical Co., Inc. HQE Class II 1986-02-07
K834160 VITREONIC PLUS American Surgical Co., Inc. HQE Class II 1986-02-07
K854854 SYSTEMS OF SIGHT LOW VISION EYEWARE Int'L Eye Care, Inc. HOI Class I 1986-02-04
K854508 STORZ DAISY Storz Instrument Co. HQE Class II 1986-02-04
K854983 OPTRONICS CONTRAST ACUITY TESTER Optronics, Inc. HOX Class I 1986-02-04
K854994 BARTELL SMALL INCISION LENS GLIDE Microtech, Inc. KYB Class I 1986-02-04
K854818 SUNGLASSES Jarnger Trading Co., Ltd. HQY Class I 1986-02-04
K860001 BARRAQUER-KRUMEICH REFRACTIVE SET American Medical Optics HNO Class I 1986-02-04
K854879 SUNGLASSES Jarnger Trading Co., Ltd. HQY Class I 1986-02-04
K854949 MODEL 9500 ARGON, KRYPTON & DYE SURGICAL LASER SYS CooperVision, Inc. HQF Class II 1986-02-04

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