meddevicedb.com FDA Device Reference

Review Panel

Ophthalmic FDA 510(k) Clearances & Devices

Cleared Devices
4,756
Product Codes (page)
31
Latest Decision
1990-07-05

Clearances · page 34 of 48

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K902150 PIEZO HANDPIECE United Surgical Corp. HQC Class II 1990-07-05
K902322 SOLAR-MATES SUNGLASSES, BONJOUR EYEWEAR Nevitt Sales Corp. HQY Class I 1990-07-05
K901945 SUNGLASSES - IMPACT RESISTANT LENSES (ACRYLIC) Zebco Corp. HQY Class I 1990-07-05
K902385 SUNSHADES, ACRYLIC LENSES, ORDER #SG-01 Tel-Time Products HQY Class I 1990-07-05
K902138 STRIPE PROJECTOR Academic Catalyst Corp. HJI Class I 1990-07-05
K900944 SUNGLASSES K Mart Apparel Corp. HQY Class I 1990-07-05
K901880 MEDILENS(TM) CORNEAL SHIELD Chiron Ophthalmics MOE Class I 1990-07-02
K901523 VKG 1000, VIDEO KERATOGRAPH The Sanborn Co. HJA Class I 1990-06-27
K902491 ECKHARDT TEMPORARY KERATOPROSTHESIS Dutch Ophthalmic USA, Inc. MLP Class II 1990-06-26
K900936 NON-PRESCRIPTION SUNGLASSES Barkley House, Inc. HQY Class I 1990-06-22
K902012 VKS-1 VIDEO KERATOSCOPE Computed Anatomy, Inc. HLQ Class I 1990-06-22
K901583 SHIN NIPPON AUTO REFRACTOMETER QR-007N Soderberg, Inc. HKO Class I 1990-06-22
K901570 SUNGLASSES STYLE #(1137) Zaks Stores, Inc. HQY Class I 1990-06-20
K900732 SPECTACLE FRAME Seiko Corp. HQZ Class I 1990-06-20
K900764 SUNGLASS, NON-PRESCRIPTION Seiko Optical Products of America, Inc. HQY Class I 1990-06-20
K901571 SUNGLASSES STYLE #(CM-1989) Zaks Stores, Inc. HQY Class I 1990-06-20
K901572 SUNGLASSES STYLE #(70116) Zaks Stores, Inc. HQY Class I 1990-06-19
K902308 TAMCENAN OCULAR EXPLANTS AND BANDS Tamcenan Corp. HQX Class II 1990-06-19
K897091 FRAME, SPECTACLE Pt Midas Surya Optical Co. HQZ Class I 1990-06-14
K901160 NUBALOO(R) SUNGLASSES Blublocker Corp. HQY Class I 1990-06-14
K901167 (EYEGLASS) FRAMES AND SUNGLASSES Optique Marquis, Div. Sugerose, Inc. HQY Class I 1990-06-14
K901513 NIDEK RT-1200S (MARCO TRS-1200) Nidek, Inc. HKO Class I 1990-06-08
K901686 NIDEK/PHACO EMULSIFICATION SYSTEM MODEL CV-8000 Nidek, Inc. HQC Class II 1990-06-08
K901036 NON-PRESCRIPTION SUNGLASSES The Bonneau Co. HQY Class I 1990-06-08
K901618 OCULAR INFUSION CANNULA SYSTEM Tamcenan Corp. HMX Class I 1990-05-31
K901748 KESTREL LENS CASE (208-12NT POLYSTYRENE) Kestrel LRX Class II 1990-05-31
K901009 MODEL 2000 INTRAOPERATIVE CORNEASCOPE Kera Corp. HLQ Class I 1990-05-30
K900942 OCULAR OCCLUDER Microdynamics HOY Class I 1990-05-25
K901363 TOPOGRAPHIC MODELING SYSTEM Computed Anatomy, Inc. HLQ Class I 1990-05-25
K901309 SYLVAN PEDIASCAN 200 TRANSILLUMINATOR Sylvan Corp. HJN Class I 1990-05-24
K896449 IM COLLAGEN SHIELD Intermedical, Inc. MOE Class I 1990-05-24
K901002 O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES Oculo Plastik, Inc. HQX Class II 1990-05-22
K900941 OMNIPATCH Eye Garter Company, Inc. HOY Class I 1990-05-21
K900929 PUTTERMAN-SCOTT, SOCKET RECONSTRUCTION BILATERAL Oculo Plastik, Inc. HQX Class II 1990-05-18
K900786 VISI-SORB ABSORBANT STICK Visitec Co. HOZ Class II 1990-05-18
K901299 CELEBRITY-CARENZA-SUNGEAR-SUMMIT SUNGLASSES Sun Mark, Inc. HQY Class I 1990-05-15
K901047 SUNGLASSES Command Marketing Corp. HQY Class I 1990-05-15
K900927 CODERE-DURETTE ORBITAL FLOOR IMPLANT Oculo Plastik, Inc. HQX Class II 1990-05-15
K901168 NON-PRESCRIPTION SUNGLASSES Renauld Intl. , Ltd. HQY Class I 1990-05-15
K900930 SPIVEY-ALLEN ORBITAL FLOOR IMPLANT Oculo Plastik, Inc. HQX Class II 1990-05-15
K900928 COX MALAR EMINENCE IMPLANTS Oculo Plastik, Inc. HQX Class II 1990-05-15
K900527 MODEL S139029 SUNGLASSES W/MIRROR ACRYLIC LENSES J & B Assoc. HQY Class I 1990-05-03
K900520 MODEL N742 SUNGLASSES W/ACRYLIC NIGHT DRIVER LENS J & B Assoc. HQY Class I 1990-05-03
K900528 MODEL 8806 SD SUNGLASSES W/ACRYLIC LENSES J & B Assoc. HQY Class I 1990-05-03
K900522 MODEL N741 SUNGLASSES W/ACRYLIC BLUE COMPUTER LENS J & B Assoc. HQY Class I 1990-05-03
K900529 MODEL 9018 PC SUNGLASSES W/POLYCARBONATE LENSES J & B Assoc. HQY Class I 1990-05-03
K900521 MODEL N742 SUNGLASSES W/POLYCARBONATE BLUE BLOCKER J & B Assoc. HQY Class I 1990-05-03
K901468 CHILDREN'S SUNGLASSES M. & S. Shillman, Inc. HQY Class I 1990-05-03
K900526 MODEL F 1 FLIP-UP SUNGLASSES W/POLORIZED LENS J & B Assoc. HQY Class I 1990-05-03
K900524 MODEL F3 FLIP UP SUNGLASSES W/POLORIZED COMPUTER J & B Assoc. HQY Class I 1990-05-03
K901161 SOLAR SHADES(TM) SUNGLASSES Blublocker Corp. HQY Class I 1990-05-01
K895813 GLAUCOMA MECHANICAL TREPHINE Trek Medical Products, Inc. HQE Class II 1990-04-30
K897089 WEE-PEEPERS (CUSHIONED CHILDREN'S SUNSHADES) Inno-Lite Co., Inc. HQZ Class I 1990-04-23
K897119 GRIESHABER RETINAL TACK AND SUTHERLAND TACK FORCEP Grieshaber & Co. HQW Class II 1990-04-12
K901100 VECTRA(TM) Optical Coating Laboratory, Inc. HQY Class I 1990-04-10
K900913 ADLER DISPOSABLE BIPOLAR CORD Adler Instrument Co. HQO Class II 1990-04-04
K897093 INTRAOCULAR MICROSCISSORS BY MEANS OF GAMMA RADIA. Microline Pentax, Inc. HNF Class I 1990-04-04
K896622 VISITEC VITRECTOMY UNIT Visitec Co. HKP Class II 1990-04-04
K900091 MODIFIED OPHTHALMIC OPIR ONUFRYK IMAGE DEFLECTOR Onufryk Low Vision Ent. HQG Class I 1990-04-04
K900778 ITEM #272 MAGNIF-EYES CONTACT LENS CASE Magnivision, Inc. LRX Class II 1990-03-30
K900777 ITEM #273 CONTACT LENS CASES Magnivision, Inc. LRX Class II 1990-03-30
K900199 LASAG MICRORUPTER 2 ND:YAG LASER TRABECULOPLASTY Lasag AG HQF Class II 1990-03-27
K900081 NEW ALLEN IMPLANT Oculo Plastik, Inc. HPZ Class II 1990-03-23
K901275 RETINAL TAAK Alcon Surgical, Inc. HQW Class II 1990-03-23
K900111 KEELER KONAN SPECULAR MICROSCOPE SP3300 Keeler Instruments, Inc. HLI Class II 1990-03-23
K900080 NEW IOWA MOTILITY IMPLANT Oculo Plastik, Inc. HPZ Class II 1990-03-23
K900090 NIKON MULTI-SPORT SUNGLASSES Oculus America HQY Class I 1990-03-12
K897186 LASER IMAGING WORK STATION Innovision Medical, Inc. HJI Class I 1990-03-12
K896943 SITE DISPOSABLE CUTTER AND ACCESSORIES Site Microsurgical Systems, Inc. HQE Class II 1990-03-08
K897084 CONFEES(R)+ CONTACT LENS HOLDER Magnivision, Inc. LRX Class II 1990-02-28
K900387 DISCO SUNGLASSES (NON-PRESCRIPTION) Le-I Electronic Co. , Ltd. HQY Class I 1990-02-28
K897085 COMFEES(R) + CON-PAK(TM) LENS CASE Magnivision, Inc. LRX Class II 1990-02-28
K900523 MODEL F3 FLIP-UP SUNGLASSES W/ACRYLIC ORANGE COMP. J & B Assoc. HQY Class I 1990-02-27
K900525 MODEL F 1 FLIP-UP SUNGLASSES W/POLYCARBONATE BLUE J & B Assoc. HQY Class I 1990-02-27
K894248 CONVERTER SYSTEM Mira, Inc. HQE Class II 1990-02-27
K900477 WOODLYN CLASSIC SLIT LAMP MODEL SMM Woodlyn, Inc. HJO Class II 1990-02-21
K900476 WOODLYN SLIT LAMP MODEL HR-1 Woodlyn, Inc. HJO Class II 1990-02-21
K900478 WOODLYN FULL APERTURE TRIAL LENS SET Woodlyn, Inc. HPC Class I 1990-02-21
K900161 A-SCAN ROLL-AROUND STAND Jedmed Instrument Co. HMG Class I 1990-02-16
K897034 K-SPONGE Katena Products, Inc. HOZ Class II 1990-02-15
K900382 BLUBLOCKER SUNGLASSES Blublocker Corp. HQY Class I 1990-02-13
K900381 COLORVISION SUNGLASSES Blublocker Corp. HQY Class I 1990-02-13
K900383 BULLET SUNGLASSES Blublocker Corp. HQY Class I 1990-02-13
K900279 OCULINUM INJECTION AMPLIFIER Oculinum, Inc. HLW Class II 1990-02-09
K896473 H200 HANNA SUCTION TREPHINE SYSTEM FOR CORNEAL SUR Emory University School of Medicine HPN Class I 1990-02-09
K884962 ADDIT. INDICATIONS FOR BIO-COR EXT COLLAGEN CORNEA Bausch & Lomb Pharmaceutical, Inc. MOE Class I 1990-02-09
K900098 MONOPOLAR NEEDLE ELECTRODE Oculinum, Inc. HLW Class II 1990-02-09
K900046 NOVELTY GRADUATION SUNGLASSES; NON-PRESCRIPTION Gibson Greetings, Inc. HQY Class I 1990-01-30
K900053 KESTREL LENS CASE 731H-893S/P-1700-2611 Kestrel LRX Class II 1990-01-30
K900054 KESTREL LENS CASE 1543-893S/P-1700-2611 Kestrel LRX Class II 1990-01-30
K895167 THE OPTIC BOX CONTACT LENS CASE The Optic Box Co., Ltd. LRX Class II 1990-01-22
K895800 ADVANCED SURGICAL SOLID STATE BIPOLAR COAGULATOR Advanced Surgical Products, Inc. HQR Class II 1990-01-22
K896754 I/A HANDPIECE Advanced Surgical Products, Inc. HQE Class II 1990-01-11
K896705 VISITEC MICRO-SPONGE SPEARS Visitec Co. HOZ Class II 1990-01-11
K896681 SOFT CORNEAL LIGHT SHIELD Visitec Co. HOY Class I 1990-01-11
K895908 MULES SPHERE GLASS (SEVERAL SIZES) Ginsberg Scientific, Inc. HPZ Class II 1990-01-08
K895864 MICRORUPTOR III SYST, Q-SWITCHED ND:YAG LASER COMP Lasag AG LXS Class II 1989-12-29
K896685 BAUSCH & LOMB FREQUENT REPLACEMENT CASE SYSTEM Bausch & Lomb, Inc. LRX Class II 1989-12-26
K896768 NON-PRESCRIPTION SUNGLASSES Shairon Intl. Trade Co. HQY Class I 1989-12-26
K896716 PLASTIC SUNGLASSES Bright Horizon Ent. HQY Class I 1989-12-26

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