meddevicedb.com FDA Device Reference

Review Panel

Ophthalmic FDA 510(k) Clearances & Devices

Cleared Devices
4,756
Product Codes (page)
42
Latest Decision
1987-11-24

Clearances · page 38 of 48

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K873987 IRAS GLARE TESTER Randwal Instrument Co., Inc. HLJ Class II 1987-11-24
K873388 KEELER CTU CRYO SYSTEM Keeler Instruments, Inc. HPS Class II 1987-11-13
K873912 RICHMOND VISUAL FIELD SCREENER Richmond Products, Inc. HOO Class I 1987-11-02
K873578 LEE ALLEN'S UNIVERSAL MOTILITY IMPLANT Oculo-Plastik Reg'D HPZ Class II 1987-11-02
K873917 TONOMETER TAPES Richmond Products, Inc. HKX Class II 1987-11-02
K874017 MODIFIED RETINAL CAMERA MODEL CR4-45NM Canon USA, Inc. HKI Class II 1987-11-02
K873422 OBF MODEL 115 COMPUTER TONOMETER SYSTEM Ocular Blood Flow Laboratories, Inc. HKX Class II 1987-11-02
K873122 TKS 4000 AUTO PERIMETER Vismed, Inc. HPT Class I 1987-11-02
K873460 OPHTHALAS DYE OPHTHALMIC LASER Biophysic Medical, Inc. HQF Class II 1987-10-29
K873919 TANGENT SCREEN Richmond Products, Inc. HOJ Class I 1987-10-28
K873909 READING CHARTS-CARDS (DISTANCE AND NEARPOINT) Richmond Products, Inc. HOX Class I 1987-10-28
K873915 JACKSON CROSS CYLINDER TEST Richmond Products, Inc. HOR Class I 1987-10-28
K873918 HEAD & CHIN RESTS Richmond Products, Inc. HRH Class I 1987-10-28
K873554 GORSK INSTRUMENT REST Gorsk, Inc. HMG Class I 1987-10-23
K872973 W-J STERILE TRI-FUNCTIONAL CONTACT LENS SOLUTION Wesley Jessen Corp. LPN Class II 1987-10-15
K872846 NIDEK ADC-8000 LASER SYSTEM Nidek, Inc. HQF Class II 1987-10-15
K873245 AR DIACOAT SINGLE VISION LENSES Seiko Optical Products of America, Inc. HQG Class I 1987-10-05
K872607 INSERT, OPTICAL, CHEMICAL-BIOLOGICAL MASK, M-17 Randolph Engineering, Inc. HQZ Class I 1987-10-05
K873662 WINK-EASE PERSONAL PROTECTIVE EYEWEAR Eye Pro Medical Products, Inc. HOY Class I 1987-10-02
K873157 OXFORD RETRO-ILLUMINATION CATARACT CAMERA Holofax , Ltd. HKI Class II 1987-09-30
K873685 NONPRESCRIPTION SUNGLASSES Arcotoys, Inc. HQY Class I 1987-09-30
K873548 OPTI-ZYME(R) Alcon Laboratories LPN Class II 1987-09-29
K873385 OPHTHALMIC PHACO-BLADE Myocure, Inc. HNN Class I 1987-09-21
K873440 RULE, PUPILLARY Allegheny Plastics, Inc. HMM Class I 1987-09-21
K872164 RESTORE Anderson Research, Inc. LPN Class II 1987-09-17
K873163 VAN DELLEN IRRIGATING CYSTOTOME Van Dellen, Ltd. HNY Class I 1987-09-04
K873162 VAN DELLEN RETROBULBAR NEEDLE Van Dellen, Ltd. HMX Class I 1987-09-04
K872802 TROKEL SINGLE MIRROR YAG LASER LENS Ocular Instruments, Inc. LQJ Class II 1987-09-04
K872747 LASER CENTERING DEVICE Innomed Corp. HMR Class I 1987-09-04
K872855 18MM PEYMAN WIDE FIELD YAG LASER LENS Ocular Instruments, Inc. HJK Class II 1987-09-04
K873164 VAN DELLEN HEALON CANNULA Van Dellen, Ltd. HMX Class I 1987-09-04
K873099 MANUAL OPHTHALMIC SURGICAL INSTRUMENTS Alcon Laboratories HNF Class I 1987-09-04
K872611 SOLOS EYESITE CAP SLEEVE Solos Ophthalmology HQC Class II 1987-08-10
K871474 PART #860070 ULTRAPAK & #860075 ULTRAPAK Medical Technical Products HOC Class I 1987-08-10
K871473 PART #860065 IA PAK & PART #860060 IA PAK Medical Technical Products HQC Class II 1987-08-10
K872567 SOFT CONTACT LENS REMOVER Magnivision, Inc. KYE Class I 1987-08-10
K872884 LOOK IRRIGATING/ASPIRATING CANNULA W/TEFLON SHEATH Look, Inc. HMX Class I 1987-08-10
K872591 HARD CONTACT LENS REMOVER. ITEM #289 Magnivision, Inc. KYE Class I 1987-08-04
K872612 SOLOS EYESITE SPONGES Solos Ophthalmology HOZ Class II 1987-07-31
K872610 SOLOS EYESITE CANNULAS Solos Ophthalmology HMX Class I 1987-07-31
K872506 MELANITE I Aura Lens Products HQG Class I 1987-07-27
K872503 FH LEN Fu Heng First Industrial Co., Ltd. HQY Class I 1987-07-27
K872362 FRIGITRONICS ACC-1000 CAPSULE CUTTER Frigitronics of Connecticut, Inc. HQC Class II 1987-07-27
K872659 TAPELESS EYE SHIELD Precision Therapeutics, Inc. HOY Class I 1987-07-27
K871854 IN-LINE OPHTHALMIC IRRIGATING SOLUTION FILTERS CooperVision, Inc. HQC Class II 1987-07-27
K871741 EASY EYES TM LENS CARRYING CASE Eaton Medical Corp. LRX Class II 1987-07-22
K872000 EYE GARD Treace Medical, Inc. HOY Class I 1987-07-21
K872312 MODEL 3000 OPHTHALMIC SURGICAL SYSTEM Allergan Humphrey HQE Class II 1987-07-15
K872218 COOL SHADES Mattel, Inc. HQY Class I 1987-06-25
K872200 HAMACHER BULLET POINT OPHTHALMIC NEEDLE R. J. Doyle, Inc. HMX Class I 1987-06-25
K871454 MORGAN THERAPEUTIC LENS Mortan, Inc. KYG Class I 1987-06-19
K872151 OPHTHALMIC CANNULA Pharmacia, Inc. HMX Class I 1987-06-19
K872136 12.5MM PEYMAN WIDE FIELD YAG LASER LENS Ocular Instruments, Inc. HJK Class II 1987-06-19
K871605 MVS 2.5MM, 4.0MM, 6.0MM INFUSION CANNULA Advanced Surgical Products, Inc. HMX Class I 1987-06-19
K871936 CANON SURGICAL AUTO KERATOMETER SK-1 Canon USA, Inc. HLQ Class I 1987-06-19
K871604 MVS 19 AND MVS 20 GAUGE SCLERAL PLUGS Advanced Surgical Products, Inc. LXP Class II 1987-06-12
K872062 EYEDENTITY EYEWEAR Vitech Research C/O Johnsen, Manfredi & Thorpe HQZ Class I 1987-06-12
K871800 SUMMIT OPTICS POST-MYDRIATIC SPECTACLES Summit Optics, Inc. HQY Class I 1987-06-11
K871871 SERIES TEN THOUSAND OCUTOME CooperVision, Inc. HQE Class II 1987-06-11
K871268 RODENSTOCK SCANNING LASER OPHTHALMOSCOPE G. Rodenstock Instrumente GmbH HLI Class II 1987-06-10
K871961 MULTIPLE SPECTACLE LENS Korea Asahi Optical Co., Ltd. HQG Class I 1987-06-03
K871485 SITE PHACOEMULSIFICATION SYSTEM/OPHTHALMIC USE Site Microsurgical Systems, Inc. HQC Class II 1987-06-03
K871935 T P C (TONOMETER PROBE COVER) Krb Ent. HKX Class II 1987-06-03
K871450 25MM PEYMAN WIDE FIELD YAG LASER LENS Ocular Instruments, Inc. HJK Class II 1987-06-03
K871735 VOROSCOPE(TM) Australian Biomedical Corporation , Ltd. HLJ Class II 1987-06-03
K870997 SOLA UV GARD(TM) SUNGLASSES Sola-Syntex Ophthalmics HQY Class I 1987-05-29
K871688 SPECTACLE FRAME - DANIELLE Roseburg SA HQZ Class I 1987-05-29
K871689 SPECTACLE FRAME - LORRAINE Roseburg SA HQZ Class I 1987-05-29
K871649 CLASSIC 70 LENS Korea Asahi Optical Co., Ltd. HQC Class II 1987-05-29
K870807 BKS-1000 REFRACTIVE SET USE IN KERATOREFRACTIVE Allergan, Inc. HNO Class I 1987-05-29
K871714 KESTREL CONTACT LENS CASE Applied Laboratories, Inc. LPN Class II 1987-05-26
K870839 MODEL 10-C W/FL-10A/U OPTICAL ATTACHMENT/OPTHALMIC Directed Energy, Inc. HQF Class II 1987-05-22
K871479 VIDEOSCAN (TM) Kera Corp. HLQ Class I 1987-05-22
K871646 TANNE CORNEAL CUTTING BLOCK Ocular Instruments, Inc. HNJ Class I 1987-05-18
K871611 ALLERGAN HUMPHREY AUTO-REFRACTOR, MODELS 525 & 540 Allergan Humphrey HKO Class I 1987-05-18
K871335 TOPCON COMPUTERIZED TONOMETER CT-10 Topcon Instrument Corporation of America HKX Class II 1987-05-18
K871130 CONTACT LENS TWEEZERS S. M. C. Medi-Tech Corp. KYE Class I 1987-05-12
K871245 LASER CONTACT LENSES CGA 1, CGI 1, CGP 1, CGV 1 Chiron Vision Corp. LQJ Class II 1987-05-07
K871375 SITE PERISTALTIC MODULE SYSTEM Site Microsurgical Systems, Inc. HQE Class II 1987-05-07
K871440 KRATZ NOVA-SERT CooperVision, Inc. KYB Class I 1987-05-07
K871099 SCHIRMER NYLON SUTURE LASER LENS Ocular Instruments, Inc. LQJ Class II 1987-04-27
K871285 KNIFE, OPHTHALMIC Trueline Instruments, Inc. HNN Class I 1987-04-27
K870179 SPECTACLE FRAMES VARIOUS COLORS AND DESIGNS Polinelli HQZ Class I 1987-04-22
K870219 LEM SUNGLASSES & FRAMES DIFF. COLORS AND DESIGNS Lem Srl. HQY Class I 1987-04-16
K871365 CAPSULECTOMER CYSTOTOME Noetix, Inc. HNY Class I 1987-04-16
K870220 LEM SPECTACLE FRAMES DIFFERENT COLORS AND DESIGNS Lem Srl. HQZ Class I 1987-04-16
K870178 SUNGLASSES AND SUNGLASS FRAMES VARIOUS COLORS Polinelli HQY Class I 1987-04-16
K863846 CONTAC CASE S. M. C. Medi-Tech Corp. LPN Class II 1987-04-06
K870671 PHACOTRON DAY PAK United Surgical Corp. HQC Class II 1987-04-06
K870775 ENTRAVISION MODECO II VITREOUS CUTTING HANDPIECE Entravision, Inc. HQE Class II 1987-03-26
K870806 NON-STERILE, EXTRA PLUS PAK CAT. #USPK 2100 United Surgical Corp. HQC Class II 1987-03-26
K870902 LOOK RETROBULBAR NEEDLES Look, Inc. HMX Class I 1987-03-20
K870750 KEELER PULSAIR NON CONTACT TONOMETER Keeler Instruments, Inc. HKX Class II 1987-03-17
K864543 SUNGLASSES Image of Hawaii HQY Class I 1987-03-13
K863346 PROFESSIONAL DISINFECTION SYSTEM (PDS) Ciba Vision Care LPN Class II 1987-02-27
K863943 POREX(TM) EYE SPHERE IMPLANT Porex Medical HPZ Class II 1987-02-27
K863946 POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT Porex Medical HQX Class II 1987-02-27
K870440 LOOK LENS LOOPS Look, Inc. HNQ Class I 1987-02-20
K870265 KRATZ NOVA-SERT. SOFT INTRAOCULAR LENS INJECTOR CooperVision, Inc. KYB Class I 1987-02-20
K870436 LOOK IRRIGATING/ASPIRATING CANNULAS Look, Inc. HMX Class I 1987-02-20

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