meddevicedb.com FDA Device Reference

Review Panel

Ophthalmic FDA 510(k) Clearances & Devices

Cleared Devices
4,756
Product Codes (page)
38
Latest Decision
1989-01-05

Clearances · page 36 of 48

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K883785 GY-RO SAFE Gy-Ro Industry, Inc. HOG Class I 1989-01-05
K885163 DIOPTICS EYESHIELDS Dioptics HOY Class I 1988-12-30
K884414 CLENSATRON AUTOMATIC CONTACT LENS CLEANER Questech Intl., Inc. LYL Class II 1988-12-29
K884251 ALLERGAN LENS CASE Allergan Optical LRX Class II 1988-12-28
K882679 SLT CONTACT LASER SYSTEM CYCLOPHOTOCOAGULATION Surgical Laser Technologies, Inc. HQB Class II 1988-12-14
K884272 WOODEN SPECTACLE FRAMES Woodwave HQZ Class I 1988-12-12
K883097 GV3000 PHACOEMULSIFIER/FRAGMENTER D.O.R.C. Intl. B.V. HQC Class II 1988-12-06
K884694 MQL 20 ND:YAG OPHTHALMIC LASER California Laboratories, Inc. LQJ Class II 1988-11-30
K884364 LABELING CHANGES TO BIO-COR EXT COLLANGEN CORNEAL Bausch & Lomb Pharmaceutical, Inc. MOE Class I 1988-11-29
K884363 LABELING CHANGES TO BIO-COR II COLLANGEN CORNEAL Bausch & Lomb Pharmaceutical, Inc. MOE Class I 1988-11-29
K884362 LABELING CHANGES TO FYODOROV COLLAGEN CORNEAL SHLD Bausch & Lomb Pharmaceutical, Inc. HQJ Class II 1988-11-29
K881971 OCCU-TECH VISION TEST Applied Vision Concepts, Inc. HOX Class I 1988-11-25
K884188 NIDEK LM-870 AUTOMATIC LENSMETER Nidek, Inc. HLM Class I 1988-11-23
K884043 GRIESHABER MICRO LITE LIGHT PIPE 19 & 20 GAUGE Grieshaber & Co. HQE Class II 1988-11-16
K872111 ORTHOTONE Orthotone Corp. HLL Class II 1988-11-16
K884360 SEIKO P-6 PROGRESSIVE SPECTACLE LENSES Seiko Corp. HQG Class I 1988-11-15
K883926 .2MM, .4MM, .5MM IRRIGATION AND ASPIRATION HAND. Site Microsurgical Systems, Inc. HQE Class II 1988-11-15
K883471 VKG 1000, VIDEO KERATOMETER Technitex, Inc. HLP Class I 1988-11-08
K883458 OPTIMED ADVANTAGE Optimed, Inc. HPT Class I 1988-11-07
K883337 PL 20/20 INFANT VISION TESTER Optimed Technologies, Inc. HOX Class I 1988-10-31
K883975 DISP. 20 GAUGE SITE FIBER OPTIC CABLE & ILLUMI. Site Microsurgical Systems, Inc. HQE Class II 1988-10-25
K883605 MODIFIED REUSABLE SITE FIBER OPTIC CABLE Site Microsurgical Systems, Inc. HQE Class II 1988-10-25
K883489 KRATZ NOVA SERT(TM) Coopervision-Cilco KYB Class I 1988-10-25
K883719 INTERCONN. OF OPHTHALAS & NANOLAS LASER SYSTEM Biophysic Medical, Inc. LQJ Class II 1988-10-18
K883270 IRIS ND:YAG OPTHALMIC LASER California Laboratories, Inc. LQJ Class II 1988-10-13
K881739 LENZ CLENZER Lens Care, Inc. LYL Class II 1988-10-07
K882908 SLT CL60 CONTACT LASER SYSTEM, CUTTING & COAGULA. Surgical Laser Technologies, Inc. HQF Class II 1988-09-30
K880920 LASER FLARE CELL METER FC-1000 Kowa Optimed, Inc. HJO Class II 1988-09-27
K882441 SLT CONTACT LASER SYSTEM ENDOPHOTOCOAGULATION Surgical Laser Technologies, Inc. HQB Class II 1988-09-26
K883099 SITE MACROBORE PHACO NEEDLE Site Microsurgical Systems, Inc. HQC Class II 1988-09-15
K883213 NIDEK OPEATING MICROSCOPE DELIVERY SYSTEM (OMDS) Nidek, Inc. HQF Class II 1988-09-15
K883771 SUNGLASSES, IMPORTED Norcon, Inc. HQY Class I 1988-09-15
K883199 MODIFICATION TO THE SITE PERISTALTIC MODULE SYSTEM Chiron Vision Corp. HQC Class II 1988-09-15
K882762 COLLAGEN SHIELD Chiron Ophthalmics MOE Class I 1988-09-12
K883575 MODIFIED SITE MOBILE STAND FOR OPHTHALMIC USE Site Microsurgical Systems, Inc. HMG Class I 1988-09-12
K881049 BRADBURY INTRAOCULAR RETINAL KIT CAT #200 Microline Pentax, Inc. HNR Class I 1988-09-12
K881519 VAC-G (GUILLOTINE VITRECTOR) B&B Medical Assoc., Inc. HQE Class II 1988-09-08
K881520 VAC (OSCILLATING VITRECTOR) B&B Medical Assoc., Inc. HQE Class II 1988-09-07
K881984 EOL, MODEL LIO Eol, Inc. HLI Class II 1988-09-06
K881494 FOUR MODIFICATIONS TO OPHTHALAS ARGON/DYE LASER Biophysic Medical, Inc. HQF Class II 1988-08-30
K883100 MULTIPLE SPECTACLE FRAMES Metal Optics U.S.A., Inc. HQZ Class I 1988-08-25
K883226 OPTICAL OR EYEGLASS FRAME Unique Optic , Ltd. HQZ Class I 1988-08-24
K883480 MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USE Site Microsurgical Systems, Inc. FCT Class II 1988-08-24
K882769 SUNGLASSES, NON-PRESCRIPTION Spotlight Industries, Inc. HQY Class I 1988-08-24
K881517 B & B I/A HANDPIECE B&B Medical Assoc., Inc. KYG Class I 1988-08-22
K872786 SUNGLASSES Quality Sunglasses, Ltd. HQY Class I 1988-08-22
K883197 IOL IMPLANTATION FORCEPS D & D Surgical HNR Class I 1988-08-22
K882402 RETRACTIVE INCISION MICROMETER (RIM) GUAGE Optical Center HNN Class I 1988-08-22
K881518 INFUSION HANDLE B&B Medical Assoc., Inc. KYG Class I 1988-08-22
K883200 CANON AUTOREFRACTOMETER R-22 Canon USA, Inc. HKO Class I 1988-08-18
K880489 CLEAR EYE GARTER SHIELD Eye Garter Company, Inc. HOY Class I 1988-08-08
K882884 STORZ INFUSION CANNULA Storz Instrument Co. HMX Class I 1988-08-04
K882750 OCU-FILM TIP COVER Oculab, Inc. HKY Class II 1988-08-04
K882902 QRK 100, QUALITATIVE RING KERATOSCOPE Technitex, Inc. HLR Class I 1988-08-04
K882372 RESUBMITTED DIODE LASER COAGULATOR CooperVision, Inc. HQF Class II 1988-08-02
K882574 BOLDREY PERIPHERAL RETINAL LENS Ocular Instruments, Inc. LQJ Class II 1988-07-29
K882814 NEOLENS PRESCRIPTION SPECTACLE LENS Neolens, Inc. HQG Class I 1988-07-29
K882813 NEOLENS SUNGLASSES Neolens, Inc. HQY Class I 1988-07-29
K882308 CR-39 PLASTIC LENSES FOR EYEGLASSES Automated Lens System HQG Class I 1988-07-22
K882634 VISUAL CONTRAST SENSITI., POTENTIAL ACUITY&GLARE Vistech Consultants, Inc. HOX Class I 1988-07-15
K882618 JEDMED/POLACK KERATOSCOPE HS/SL Gamut Ent. HLR Class I 1988-07-13
K881135 COOL EYE(TM) EYE PROTECTOR Cool Eyes, Inc. HOY Class I 1988-07-08
K881635 NOETIX(R) SURGICAL EXTRACTION(TM) SYSTEM Noetix, Inc. HQC Class II 1988-07-01
K882191 NIDEK ARK-2000 Nidek, Inc. HKO Class I 1988-07-01
K880543 UNI-PORT Surgeon Surgical Instrumentation, Inc. KYG Class I 1988-07-01
K882103 SITE ULTRASONIC I/A PHACO NEEDLE Site Microsurgical Systems, Inc. HQC Class II 1988-07-01
K882287 CANON AUTOREFRACTOMETER R-20 Canon USA, Inc. HKO Class I 1988-07-01
K882575 DISTOMETER Hagg-Streit Service, Inc. HMM Class I 1988-07-01
K881682 ALCON SITE(R)-COMPATIBLE CASSETTE Alcon Laboratories KYG Class I 1988-07-01
K880666 ULTRAVIOLET LIGHT PROTECTVE EYEWERE Free Sun Intl. AB HOY Class I 1988-06-28
K880688 SLC HARD LENS CLEANER Ocular Pharmaceuticals, Inc. LPN Class II 1988-06-28
K881358 PG CONSEN CONTRAST SENSITIVITY TESTING PROGRAM Neuroscientific Corp. HOX Class I 1988-06-27
K881987 DURACLEAN DAILY CLEANER Allergan Optical LPN Class II 1988-06-09
K875260 EFFNER CAUTERY INSTRUMENTS Effner and Spreine Co. HQP Class II 1988-06-06
K881926 REUSABLE FIBEROPTIC LIGHTPIPE Advanced Surgical Products, Inc. HQB Class II 1988-06-06
K881134 SLT CONTACT LASER SYSTEM OCULOPLASTICS Surgical Laser Technologies, Inc. HQF Class II 1988-06-06
K880943 MICROLINE CAT #100 Microline Pentax, Inc. HQE Class II 1988-05-26
K881594 SUNGLASSES Transfers Intl., Inc. HQY Class I 1988-05-25
K881927 PRISMA TECH 19 GAUGE DISPOSABLE EXTRUSION NEEDLES Advanced Surgical Products, Inc. HQE Class II 1988-05-25
K880929 NIDEK CV-4000 Nidek, Inc. HQE Class II 1988-05-25
K881419 PLASTIC FRAME & LENS SUNGLASS Marketing Innovations Intl., Inc. HQY Class I 1988-05-25
K881278 SPECTACLE, FRAME AND SUNGLASSES Nouvelle Ligne Paris HQY Class I 1988-05-25
K881515 TEAR VOLUME TESTS Visionex, Inc. KYD Class I 1988-05-23
K881001 MENTOR WET-FIELD*II COAGULATOR Mentor O & O, Inc. HQQ Class II 1988-05-13
K880952 PRISMA DISPOSABLE 19 AND 20 GAUGE SCLERAL PLUGS Advanced Surgical Products, Inc. LXP Class II 1988-05-13
K881669 MVR/STILETTO BLADE 20GA. - P/N 1900 Advanced Surgical Products, Inc. HNN Class I 1988-05-13
K880953 ADVANCED SURGICAL 19 & 20 GAUGE DISP. SCLERAL PLUG Advanced Surgical Products, Inc. LXP Class II 1988-05-13
K880347 ANESTHESIA/RETROBULBAR NEEDLES Myocure, Inc. HMX Class I 1988-05-03
K875030 OCU-1 Rudolph Beaver, Inc. HMX Class I 1988-05-03
K880490 BLUE PLASTIC EYE SHIELD Eye Garter Company, Inc. HOY Class I 1988-05-03
K880345 CYSTOTOMES/KNIFES Myocure, Inc. HNY Class I 1988-05-03
K880346 CANNULAS Myocure, Inc. HMX Class I 1988-05-03
K881219 AUTOMATIC PERIMETER, AP-340 Kowa Optimed, Inc. HPT Class I 1988-05-03
K881487 OPHTHALMIC CANNULA Surgical Instrument, Inc. HMX Class I 1988-04-29
K880968 MODEL 2001 PHACOEMULSIFIER ASPIRATOR Mcghan Instrumed Corp. HQE Class II 1988-04-19
K881225 OPHTHALMIC SPECTACLE LENS BLANKS Beta Optical Co, Inc. HQG Class I 1988-04-19
K874996 PRISMA DISPOSABLE KUGLEN IRRIGATING LENS MANIPULA. Advanced Surgical Products, Inc. HMX Class I 1988-04-13
K874981 PRISMA DISPOSABLE J-SHAPED I/A CANNULA Advanced Surgical Products, Inc. HMX Class I 1988-04-13
K874974 PRISMA DISPOSABLE SIMCOE CAPSULE POLISHER Advanced Surgical Products, Inc. HMX Class I 1988-04-13
K874979 PRISMA DISPOSABLE MVR/STILETTO BLADE Advanced Surgical Products, Inc. HNN Class I 1988-04-13

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