meddevicedb.com FDA Device Reference

Review Panel

Ophthalmic FDA 510(k) Clearances & Devices

Cleared Devices
4,756
Product Codes (page)
40
Latest Decision
1992-03-02

Clearances · page 32 of 48

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K920069 MAGNI-CAM Innoventions, Inc. HJG Class I 1992-03-02
K914393 RETINA TESTER Retina Tester HLX Class II 1992-03-02
K915630 OPHTIMPLANT Oculo Plastik, Inc. HPZ Class II 1992-03-02
K915783 S.A.A. EYE GLASS FRAMES Yau Yee Optical Co., Ltd. HQZ Class I 1992-02-27
K914954 SPECTACLE FRAMES+ SUNGLASSSES(NON PRESC.) Jsu Corp. HQZ Class I 1992-02-27
K915457 PHACO 20/20 SYSTEM I Innovative Medical Systems, Inc. HQC Class II 1992-02-24
K913504 STORZ MICRO CUTTER 25 GAUGE PACK Storz HQE Class II 1992-02-21
K915356 OPACITRAC Oculon Corp. HJO Class II 1992-02-21
K914310 OPTICAL FRAMES & SUNGLASSES Societe Nouvelle Idc HQY Class I 1992-02-19
K915456 PHACO 3000 LINEAR Innovative Medical Systems, Inc. HQC Class II 1992-02-12
K913419 REGENCY, COMPARE, SUN OPTICS SUNGLASSES Cliff Weil, Inc. HQY Class I 1992-02-12
K920165 SUNGLASSES (NON-PRESCRIPTION) Blair Corporation HQY Class I 1992-02-11
K913686 SUNSHADES, ACRYLIC LENSES, SILVER COATED #HX-602 Tel-Time Products HQY Class I 1992-02-11
K913852 LASER FLARE METER Kowa Optimed, Inc. HJO Class II 1992-02-07
K914483 WETTING SOLUTION FOR HARD CONTACT LENSES Optopics Laboratories Corp. LPN Class II 1992-02-05
K915074 IRRIGATOR/ASPIRATOR PROBE Biomedical Dynamics, Inc. HMX Class I 1992-02-05
K912576 INSTRUMENT WIPE AND CORNEAL SHIELD Katena Products, Inc. HOY Class I 1992-01-31
K913239 GOLDLENS(TM) Doran Instruments, Inc. HLZ Class II 1992-01-31
K913261 DWYER EYE SYSTEMS ASPIRATION UNIT Spectracare, Inc. HQE Class II 1992-01-30
K914311 CHIROFLEX II LENS MICROSERT(TM) Chiron Ophthalmics HQL Class III 1992-01-27
K914587 GRIESHABER AIR/FLUID TUBING SET Grieshaber & Co. KYG Class I 1992-01-23
K914896 FRIEDMANN ANALYSER 3 Clement Clarke, Inc. HOK Class I 1992-01-23
K913314 CANDELA RETINAL CAMERA Candela Laser Corp. HKI Class II 1992-01-23
K915062 DOHLMAN DOANE KERATOPROTHESIS Mackeen Consultants, Ltd. HQM Class II 1992-01-21
K914766 SUN SIGHT SUNGLASSES/SUN SIGHT READING GLASSES Sun Sight Glasses Co., Ltd. HQY Class I 1992-01-17
K915082 OPTI-LENS(TM) CONTACT LENS CASE Ryder Intl. Corp. LRX Class II 1992-01-13
K912509 MOSSIMO OPTIC EYEWEAR Mossimo, Inc. HQY Class I 1992-01-06
K914484 LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPE Hgm Medical Laser Systems, Inc. HLI Class II 1992-01-06
K914407 PROMOGLASS(TM) SUNGLASSES (NON-PRESCRIPTION) Promedex, Inc. HQY Class I 1991-12-31
K914425 PYRAMID SUNGLASSES/READING GLASSES Pyramid HQY Class I 1991-12-31
K914413 SPECTACLE FRAMES Mikado Ca. HQZ Class I 1991-12-31
K914614 FRAMES (SPECTACLES) VARIOUS TYPES Match Optical Co. HQZ Class I 1991-12-30
K912740 ACT-1 (ANTERIOR CORNEAL TOPOGRAPHER) Visionary Systems, Inc. HLQ Class I 1991-12-30
K914229 PHACO TIP Tri-Star Ophthalmic HQC Class II 1991-12-27
K915118 PHACO EMULSIFICATION,IRRIGATION/ASPIRATION TUBE Ipax, Inc. HQC Class II 1991-12-27
K912747 LULMITEX NEONATAL TRANSILLUMINATOR Lumitex, Inc. HJN Class I 1991-12-24
K912384 DISPOSABLE SUPPLIES KIT FOR PEA PROCEDURE Nidek, Inc. HQE Class II 1991-12-24
K912581 ZEISS CONFOCAL LASER SCANNING OPHTHALMOSCOPE(CLSO) Carl Zeiss, Inc. HLI Class II 1991-12-23
K913626 SOFTRANS INJECTOR Staar Surgical Co. HQL Class III 1991-12-18
K912902 PHACOEMULSIFICATION SYSTEM FOR OPHTHALMIC USE Site Microsurgical Systems, Inc. HQC Class II 1991-12-17
K914239 FRAMES (SPECTACLES) Jane Fui Optical Co., Ltd. HQZ Class I 1991-12-16
K912514 TANDEM SCANNING MICROSCOPE Tandem Scanning Corp. HJO Class II 1991-12-16
K914038 POLLY'S CUTTER J-225 O.R. Specialties, Inc. HQE Class II 1991-12-09
K914051 PEDIATRIC VITRECTOMY LENS SET Ocular Instruments, Inc. HJK Class II 1991-12-09
K913961 OPHTHALMIC STAND Luneau Ophtalmologie SA HMF Class I 1991-12-04
K913273 DROLITE(TM) LIGHT SOURCE Vision Medical, Inc. HJM Class II 1991-12-04
K913929 DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM Ophthalmic Imaging Systems HKI Class II 1991-11-27
K914117 LANDERS HIGH REFRACTIVE INDEX VITRECTOMY LENS SET Ocular Instruments, Inc. HJK Class II 1991-11-13
K914529 SOFTSHIELD(TM) 12, 24, 72 COLLAGEN CORNEAL SHIELDS Oasis Medical, Inc. MOE Class I 1991-11-13
K911734 TEARTEC RAPID LACRIMAL ASSESMENT SYSTEM Northland Cataract & Eye Care Clinic KYD Class I 1991-11-07
K913837 MICROSCIS(TM) INTROCULAR SCISSOR SYSTEM Vision Medical, Inc. HQE Class II 1991-11-05
K913697 AUTOMATIC CORNEAL SHAPER Hansa Research & Development, Inc. HNO Class I 1991-11-05
K914095 PEEPERS TANNING GOGGLES California Suncare, Inc. HOY Class I 1991-10-30
K914172 KPE 230 AM Ipax, Inc. HQC Class II 1991-10-25
K914221 KPE 220 TS, NONSTERILE Ipax, Inc. HQE Class II 1991-10-25
K914163 SCOPTOPIC SENSITIVITY TEST-1[SST-1] Lkc Technologies, Inc. HLX Class II 1991-10-25
K913962 ANOMALOSCOPE QUADRANT TEST-6 Lkc Technologies, Inc. HIW Class I 1991-10-23
K912397 PROFESSIONAL INDIRECT OPHTHALMOSCOPE Clement Clarke, Inc. HLI Class II 1991-10-23
K913530 LOOK VISCODISSECTOR Look, Inc. HQC Class II 1991-10-21
K913640 DR. DEAN EDELL SOLARBLOC SUNGLASSES Cable Car Sunglasses HQY Class I 1991-10-21
K913189 NIDEK MODEL NT-1000 Nidek, Inc. HKX Class II 1991-10-15
K913148 COLLAGEN SHIELD FOR ACUTE CARE Vitaphore Corp. MOE Class I 1991-10-15
K913745 DUCAL SIDE SHIELD SUNGLASS Ducal Trading Corp. HQY Class I 1991-10-15
K902920 TURBOTRON 20/20 Prestige Manufacturing Snd Bhd LYL Class II 1991-10-10
K913118 GLAUCOMA-SCOPE Ophthalmic Imaging Systems HLI Class II 1991-10-09
K913022 CCI VIDEOKERATOSCOPE/COMPARATOR Cci HLQ Class I 1991-10-09
K913388 THE PAN.OPTX SPORTGLASS Panoptx, Inc. HQY Class I 1991-10-02
K913230 UNIDIRECTIONAL OCCLUDER Welch Allyn, Inc. HOY Class I 1991-10-02
K912367 EYE BUBBLE Aaron Medical Industries HOY Class I 1991-10-02
K912891 HEIDELBERG RETINA TOMOGRAPH Heidelberg Engineering HLI Class II 1991-09-27
K912863 DESERT SHIELD SUNGLASSES Command Marketing Corp. HQY Class I 1991-09-25
K904961 ARTIFICIAL SCLERAL SHELL Midwest Eye Laboratories, Inc. HQT Class II 1991-08-30
K904962 EYE ARTIFICIAL CUSTOM Midwest Eye Laboratories, Inc. HQH Class I 1991-08-30
K913046 FRAMES (EYE GLASSES) Jiuh Chyi Ent. Co., Ltd. HQZ Class I 1991-08-28
K912739 SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH USE Site Microsurgical Systems, Inc. HQC Class II 1991-08-28
K912034 VENETO COLLECTION Atlantic Optical Co., Inc. HQZ Class I 1991-08-22
K910828 LANDERS WIDE FIELD TEMPORARY KERATOPROSTHESIS Ocular Instruments, Inc. MLP Class II 1991-08-21
K912608 STAR*SHADES(TM) SUNGLASSES Nalpac , Ltd. HQY Class I 1991-08-21
K911886 PMT METAL LOCATOR, MODEL 3630-1 Pmt Corp. HPM Class II 1991-08-12
K912130 TBD KERATOSCOPE Alcon Laboratories HLQ Class I 1991-08-09
K912269 LANDERS NOTCHED IRRIGATING VITRECTOMY LENS RING Ocular Instruments, Inc. HNH Class I 1991-08-07
K912268 LANDERS NOTCHED VITRECTOMY LENS RING Ocular Instruments, Inc. HNH Class I 1991-08-07
K912253 LANDERS 3 STRUT IRRIGATING VITRECTOMY LENS RING Ocular Instruments, Inc. HQE Class II 1991-08-07
K911998 MULTITOME MODEL 1000, VITRECTOMY DRIVING SYSTEM Allergan Medical Optics HQE Class II 1991-07-26
K911374 PLASTIC OVERLAYS National Reading Service HKW Class I 1991-07-26
K912134 TBD, LENS MEASURING DEVICE Alcon Laboratories HRJ Class I 1991-07-25
K912151 LANDERS THREE STRUT VITRECTOMY LENS RING Ocular Instruments, Inc. HNH Class I 1991-07-25
K904824 EASY EYES TM CONTACT LENS CLEANING MACHINE Eaton Medical Corp. LYL Class II 1991-07-05
K912366 MAINSTER HIGH MAGNIFICATION LASER LENS Ocular Instruments, Inc. HJK Class II 1991-06-25
K911808 GEMINI OPHTHALMIC SURGERY SYSTEM Alcon Laboratories HQC Class II 1991-06-25
K903001 SLIMCATH (TM) Gynopharma, Inc. HIT Class I 1991-06-25
K911721 KEELER PULSAIR NON CONTACT TONOMETER, MODIFICATION Keeler Instruments, Inc. HKX Class II 1991-06-25
K911110 OPHTA SIL(R), ENULCEATION/EVISCERATION IMPLANTS G.W.B. Intl., Ltd. HPZ Class II 1991-06-18
K911439 NON-MYDRIATIC RETINAL CAMERA, CR-45UAF Canon USA, Inc. HKI Class II 1991-06-17
K912112 PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480 Tomey Corporation USA LQJ Class II 1991-06-17
K905825 COLLAGEN SHIELD, VARIOUS MODELS Chiron Ophthalmics MOE Class I 1991-06-10
K911277 ORIGINALS Face 2 Face Corp. HQY Class I 1991-06-06
K910532 URAM OPHTHALMIC LASER ENDOSCOPE Martin S. Knopf Assoc., Inc. HQF Class II 1991-05-28
K910805 ND:YAG LASER SYSTEMS (VARIOUS MODELS) Heraeus Lasersonics, Inc. HQF Class II 1991-05-24
K911766 SUNGLASSES-NONPRESCRIPTION INCLUDING PHOTOSEN. Gall'S, Inc. HQY Class I 1991-05-22

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