meddevicedb.com FDA Device Reference

Review Panel

Ophthalmic FDA 510(k) Clearances & Devices

Cleared Devices
4,756
Product Codes (page)
29
Latest Decision
1991-05-22

Clearances · page 33 of 48

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K910980 SITE 20 GAUGE REUSABLE FIBER OPTIC CABLE Site Microsurgical Systems, Inc. HJO Class II 1991-05-22
K911062 QUALITATIVE KERATOMETER M823 WITH POWER SUPPLY Storz Instrument Co. HNO Class I 1991-05-22
K910601 PATHFINDER Nurion Industries HPG Class I 1991-05-14
K911332 SPECTACLE FRAME Australian Optical Co., Inc. HQZ Class I 1991-05-06
K910951 OPTHLAMIC FRAMES United Optical, Spa HQZ Class I 1991-05-06
K910415 SUNGLASSES K.M Optical Co. HQY Class I 1991-05-01
K910973 DISPOSABLE IRRIGATING/ASPIRATING HANDPIECE Surgical Technologies, Inc. HQE Class II 1991-04-26
K910597 SUNGLASSES MODEL #SP PROMO #1 AND SP PROMO #2 Radix Group Intl. HQY Class I 1991-04-26
K904699 COMPAC(TM) DIODE LASERS Hgm Medical Laser Systems, Inc. HQF Class II 1991-04-25
K910124 LOW VISION ENHANCEMENT SYSTEM (LVES) Triangle Investments HPG Class I 1991-04-10
K910179 OPTICAL FRAME Australian Optical Co., Inc. HQZ Class I 1991-04-10
K910707 OPERAID SURGICAL DRAIN W/ CORNEAL SHIELDS Jedmed Instrument Co. HOZ Class II 1991-04-10
K910088 SCITECH BI-MANUAL ADAPTER CLIPS Scitech Industries Partnership HQQ Class II 1991-04-08
K910134 OPTICAL FRAME (HELEN,ARNOLD,VANA,BRUCE,MATT) Kentucky Optical Co. HQZ Class I 1991-03-15
K910904 INTEGO Racal Health & Safety, Inc. HQY Class I 1991-03-15
K905703 KRUPIN EYE VALVE WITH DISK Hood Laboratories KYF Class II 1991-03-15
K905864 SUNGLASSES (NON-PRESCRIPTION) The Limited Stores, Inc. HQY Class I 1991-03-14
K910127 SUNGLASSES, NON-PRESCRIPTION (POLINELLI) The Limited Stores, Inc. HQY Class I 1991-03-14
K910126 SUNGLASSES, NON-PRESCRIPTION (ITALO CREMONA) The Limited Stores, Inc. HQY Class I 1991-03-14
K910125 SUNGLASSES/NON-PRESCRIPTION (LA GIARDINIERA) The Limited Stores, Inc. HQY Class I 1991-03-14
K902296 TRABECULO-SUPRACHOROIDAL SHUNT Visionex, Inc. KYF Class II 1991-03-14
K910329 SUNGLASSES Cutler & Gross Sloan Optical , Ltd. HOI Class I 1991-03-12
K905453 CRYSTAL FOCUS EMERALD LASER/SLT OPHF 0.6 ENDO HAND Douglas James Donaldson Compliance Services HQF Class II 1991-03-05
K910612 CANDELA DIODE TRABECULOPLASTY LASER DTL Candela Laser Corp. HQF Class II 1991-03-04
K905183 NEON RUBBER SUNGLASSES Ha-Lo Advertising Specialties, Inc. HQZ Class I 1991-03-04
K910626 J&B OPTICAL FRAMES J & B Optical, Inc. HQZ Class I 1991-02-26
K904074 VITREORETINAL INFUSION CANNULA Visitec Co. HMX Class I 1991-02-26
K902343 SUNGLASSES Jasco Products Co., Inc. HQY Class I 1991-02-26
K905237 EYE SEE INSTRUMENT King Tool, Inc. HPN Class I 1991-02-14
K903065 PRIMARY MANUFACTURER SUNGLASSES Mao Lin Ent. HQY Class I 1991-02-13
K910141 CHILDREN SUNGLASSES Consolidated Stores Intl. Corp. HQY Class I 1991-02-13
K905129 BAERVELDT GLAUCOMA IMPLANT Wright Medical Corp. KYF Class II 1991-02-11
K905141 CENTAURI Pfizer Laser Systems HQF Class II 1991-02-11
K905041 SUNGLASSES Eskco, Inc. HQY Class I 1991-02-05
K904909 I/A VITROPHAGE MODEL YPR 2001 Visioncare Devices, Inc. HQE Class II 1991-01-28
K904981 FUNKY SUNGLASS Monogram International,Inc. HQY Class I 1991-01-28
K910231 NMR-K FUNDUS LASER LENS Ocular Instruments, Inc. HJK Class II 1991-01-28
K904161 JMB TRADING COMPANY SUNGLASSES Jmb Trading Co. HQY Class I 1991-01-23
K904845 STORZ DRAEGER ROTOR KERATOME Storz Instrument Co. HNO Class I 1991-01-22
K904828 OPTEC 2300 AFVT, ARMED FORCES VISION TESTER Stereo Optical Co., Inc. HKO Class I 1991-01-18
K904612 I/A-PHACO SYSTEM (IRR./ASPIR./AND PHACO./SYSTEM) Medical Technical Products HQC Class II 1990-12-26
K903575 CHIROFLEX FORCEPS Chiron Ophthalmics KYB Class I 1990-12-21
K902306 THE VISONIC DOME(TM) Vista Vision LYL Class II 1990-12-21
K903421 TOPCON EC-200 ENDO-PHOTOCOAGULATOR LASER Top Con HQF Class II 1990-12-18
K901605 PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA. Phoenix Laser Systems, Inc. LXS Class II 1990-12-13
K902225 CHILDRENS SUNGLASSES Jasco Products Co., Inc. HQY Class I 1990-12-07
K904183 SITE PHACOEMULSIFICATION HANDPIECE Site Microsurgical Systems, Inc. HQC Class II 1990-12-05
K904151 SITE 19 GAUGE ULTRASONIC I/A PHACO NEEDLE Site Microsurgical Systems, Inc. HQC Class II 1990-12-05
K904281 NONPRESCRIPTION SUNGLASSES Jennie G. Sales Co., Inc. HQY Class I 1990-11-21
K904186 SITE DIAPHRAGM CASSETTE Site Microsurgical Systems, Inc. KYG Class I 1990-11-21
K903666 OPHTHASONIC A/P III Teknar, Inc. HPY Class I 1990-11-19
K903487 SOLARSHIELDS ENCORE Dioptics HQY Class I 1990-11-05
K903878 MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT Mentor O & O, Inc. HQQ Class II 1990-11-05
K904197 CHILDRENS SUNGLASSES Jasco Products Co., Inc. HQY Class I 1990-11-05
K903902 SUNGLASSES K & P Trading Co., Inc. HQY Class I 1990-10-26
K904585 POST MYDRIATIC SPECTACLES Yorktowne Optical Co., Inc. HQY Class I 1990-10-26
K902301 SUNSHADES, ACRYLIC LENSES #SG-01 Tel-Time Products HQY Class I 1990-10-23
K904366 CRYSTAL FOCUS EMERALD-CW LASER PHOTOCOAGULATOR Douglas James Donaldson Compliance Services HQF Class II 1990-10-19
K903912 KERATOME Micro Precision Instrument Co. HNO Class I 1990-10-17
K903462 OPTIMED GLAUCOMA PRESSURE REGULATOR Optimed, Inc. KYF Class II 1990-10-16
K903721 WRAP-AROUND INSTANT SUNGLASSES Yorktowne Optical Co., Inc. HQY Class I 1990-10-11
K903720 FLAT FIT-IN SUNGLASSES Yorktowne Optical Co., Inc. HQY Class I 1990-10-11
K902224 SUNGLASSES Jasco Products Co., Inc. HQY Class I 1990-10-11
K904345 FASHION FRAMES Sunland Optical Co. HQZ Class I 1990-10-11
K903719 FLAT SLIP-IN SUNGLASSES Yorktowne Optical Co., Inc. HQY Class I 1990-10-11
K903303 SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES Spembly Medical , Ltd. HPS Class II 1990-10-11
K903558 LASER CANE Nurion Industries HPG Class I 1990-09-27
K902519 EYE SPY SUNGLASSES E. M. Intl. Products , Ltd. HQY Class I 1990-09-24
K903826 SARAH COVENTRY SUNGLASSES R. N. Koch, Inc. HQY Class I 1990-09-24
K904037 PUMUCKL AND/OR DIETERLE Pumuckl HQZ Class I 1990-09-24
K900907 CARTIER SUNGLASSES, MUST DE Cartier, Inc. HQY Class I 1990-09-19
K902876 PHACOTRON SYSTEMS PLUS III PHACOEMULSIFIER ASPI. Intraoptics Surgical, Inc. HQC Class II 1990-09-18
K902878 MT-336 AUTOMATIC PERIMETER Marco Technologies HPT Class I 1990-09-18
K903739 SUNGLASSES W/NON PRESCRIPT LENSES W/PHOTO SENSITIV Nouveau Eyewear HQY Class I 1990-09-17
K903574 CHIROFLEX LENS MICROSERT Chiron Ophthalmics KYB Class I 1990-09-17
K903949 FRAME, SPECTACLE Eureka Optics, Inc. HQZ Class I 1990-09-10
K902280 RAD-X GLASSES Compudrug HQY Class I 1990-09-10
K903202 TOY SUNGLASSES Creative Design HQY Class I 1990-08-28
K897090 SUNGLASSES Pt Midas Surya Optical Co. HQY Class I 1990-08-28
K900493 THE PRECISIONIST Paradigm Medical, Inc. HQC Class II 1990-08-28
K902798 AUTOMATED HYDROSONICS(TM) Alcon Surgical, Inc. HQC Class II 1990-08-28
K902558 COLLAGEN SHIELD FOR ACUTE CARE Vitaphore Corp. MOE Class I 1990-08-17
K902489 MODIFIED MOLTENO(TM) IMPLANTS Iop, Inc. KYF Class II 1990-08-14
K902415 VISION JANTZEN SUNGLASSES Vision Products Co., Inc. HQY Class I 1990-08-08
K902187 POLARON Nurion Industries HPG Class I 1990-08-08
K902868 RUBBER SUNGLASSES Premium Source Merchandising HQY Class I 1990-08-08
K902033 MAGIC HOT SHADES 70116, 70118, 70119 Nationmark, Inc. HQY Class I 1990-08-08
K903173 LAURENT TARDY Acces Intl. Eyewear HQZ Class I 1990-08-02
K902857 VISI-DRAPE OPHTHALMIC DRAPES Visitec Co. HMY Class I 1990-07-31
K902500 AR-1600G AUTO-REFRACTOMETER Nidek, Inc. HKO Class I 1990-07-27
K900877 OPTHALMIC QUALITY SUNGLASSES, NON-PRESCRIPTION Sunglass Originals, Inc. HQY Class I 1990-07-27
K902750 VISI-SWAB OPHTALMIC SPONGE Visitec Co. HOZ Class II 1990-07-26
K902117 FESAN SUNGLASSES Fesan, S.A. HQY Class I 1990-07-24
K902496 LANDERS VITRECTOMY LENS RING W/INFUSION Ocular Instruments, Inc. HNH Class I 1990-07-24
K902186 SUNGLASSES Creative Paper Products, Inc. HQY Class I 1990-07-24
K901553 SURG-K SURGICAL KERATOMETER The Sanborn Co. HLR Class I 1990-07-20
K901802 TOY SUNGLASSES Sirco Intl. Corp. HQY Class I 1990-07-19
K902414 OPTI-RAY SUNGLASSES Opti-Ray, Inc. HQY Class I 1990-07-17
K895741 CLAS PHOTOKERATOSCOPE Kera-Metrics Corp. HLQ Class I 1990-07-11
K901839 60 FUNDUS CAMERA CF-60UV Canon USA, Inc. HJI Class I 1990-07-05

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