meddevicedb.com FDA Device Reference

Review Panel

Ophthalmic FDA 510(k) Clearances & Devices

Cleared Devices
4,756
Product Codes (page)
37
Latest Decision
2003-05-06

Clearances · page 14 of 48

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K031312 RTA MODEL D RETINAL THICKNESS ANALYZER Talia Technology , Ltd. HLI Class II 2003-05-06
K024289 BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTION Bausch & Lomb, Incorporated MRC Class II 2003-05-02
K030433 STRATUSOCT WITH RNFL NORMATIVE DATABASE Carl Zeiss Meditec, Inc. HLI Class II 2003-05-01
K023676 APPLANATION TONOMETER Optilasa, S.L. HKX Class II 2003-04-24
K023623 NOVAVISION, MODEL 2.0 Novavision, Inc. HPT Class I 2003-04-22
K023939 VELOCITY ADVANTAGE Visioncare Devices, Inc. HQE Class II 2003-04-17
K030471 OPHTEC ENCLAVATION NEEDLE Ophtec, USA HNQ Class I 2003-04-17
K030548 SAVIEW 55 MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR St. shine Optical Co., Ltd. LPL Class II 2003-04-04
K030092 COMPLETE BRAND MULTI-PURPOSE SOLUTION Advanced Medical Optics, Inc. LPN Class II 2003-04-04
K030167 MIERU (ETAFILCON A) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH UV BLOCKER Clearlab Pte , Ltd. LPL Class II 2003-04-02
K030027 GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT; GELFLEX HIOXIFILCON SOFT CONTACT LENS 49% Gelflex Laboratories LPL Class II 2003-04-01
K030350 EXPRESS MINI GLAUCOMA SHUNT Optonol, Ltd. KYF Class II 2003-03-13
K023455 AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION Ciba Vision Corporation MRC Class II 2003-02-28
K022186 SCLERAL PLUGS, 19 AND 20 GAUGE Microvision, Inc. LXP Class II 2003-02-26
K023987 CONTAFLEX 38 (POLYMACON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) Contamac, Ltd. LPL Class II 2003-02-26
K023989 CONTAFLEX 55 (METHAFILCON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) Contamac, Ltd. LPL Class II 2003-02-26
K030054 DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES Fci Ophthalmics, Inc. HJK Class II 2003-02-26
K023643 MACROPORE SURGICAL BARRIER FILM Macropore Biosurgery, Inc. MTZ Class II 2003-02-21
K023838 LUNEAU STERILE TONOMETER SEPARATION PRISMS Luneau SA HKY Class II 2003-02-20
K024045 CONTAFLEX GM3 49% (ACOFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) Contamac, Ltd. LPL Class II 2003-02-14
K024164 COMFORTKONE KERATOCONUS ASPHERIC (HYBUFOCON A, FILOFILCON A, PEMUFOCON A) RIGID GAS PERMEABLE (RGP) DAILY WEAR CONTACT Metro Optics, Inc. HQD Class II 2003-02-12
K024003 GELFLEX DELTA SOFT CONTACT LENS MATERIAL METHAFILCON A 55% WATER CONTENT CLEAR OR BLUE VISITINT, GELFLEX ALPHA SOFT CONT Gelflex LPL Class II 2003-02-05
K021750 LID CHAIN EYELID WEIGHTS Jedmed Instrument Co. MML Class II 2003-01-27
K030179 MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES Surgical Instruments Service and Savings, Inc. NKX Class II 2003-01-24
K024177 ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER Johnson & Johnson Vision Care, Inc. LPL Class II 2003-01-22
K023791 NUSOFT SPHERICAL, TORIC, ASPHERIC AND BIFOCAL (OCUFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR Softfocal Company, Inc. LPL Class II 2003-01-10
K023481 MICROVISION SCLERAL BUCKLING COMPONENTS Microvision, Inc. HQX Class II 2003-01-08
K022723 MASTEL 1 FOLDER IMPLANTATION SYSTEM Mastel Precision, Inc. KYB Class I 2002-12-26
K023349 CONTAFLEX GM3 58% (ACOFILCON A) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) Contamac, Ltd. LPL Class II 2002-12-24
K023719 MP-1 MICRO PERIMETER Nidek Technologies Srl HKI Class II 2002-12-23
K023094 IRIDIS OPHTHALMIC PHOTOCOAGULATOR Quantel Medical HQF Class II 2002-12-17
K021699 AUTOLENS CLEANING AND DISINFECTING UNIT Autolens, Inc. LYL Class II 2002-12-16
K020482 KERATOME BLADE 200200 & 600600 Micro Specialties, Inc. HNO Class I 2002-12-16
K021643 HA ORBITAL IMPLANT Laboratoire Villanova HPZ Class II 2002-12-13
K023077 OCU-FLEX PEDIATRIC APHAKIC (OCUFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (LATHE-CUT) Ocu-Ease Optical Products, Inc. LPL Class II 2002-12-10
K023732 CIBASOFT PROGRESSIVE TORIC (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR Ciba Vision Corporation LPL Class II 2002-12-10
K023530 HORIZON 38 (CLEAR) AND HORIZON 38 WESTINT (TINTED) Westcon Contact Lens Co., Inc. LPL Class II 2002-11-26
K023816 CANON FULL AUTO TONOMETER TX-F Canon, Inc.-Utsunomiya Optical Products Operation HKX Class II 2002-11-26
K022687 AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION Ciba Vision Corporation LYL Class II 2002-11-19
K022982 MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB Med-Logics, Inc. HNO Class I 2002-11-15
K020888 FUNDUS AUTOIMAGER Visual Pathways, Inc. HKI Class II 2002-11-07
K022840 STEPHENS DISPOSABLE SCISSORS Stephens Instruments HNF Class I 2002-11-01
K022836 STEPHENS DISPOSABLE SPECULUM Stephens Instruments HNC Class I 2002-11-01
K022842 STEPHENS DISPOSABLE HOOKS Stephens Instruments HNQ Class I 2002-11-01
K022835 STEPHENS DISPOSABLE FORCEPS Stephens Instruments HNR Class I 2002-11-01
K022843 GAYHEART CORNEAL EXCISION DEVICE Stephens Instruments HRH Class I 2002-11-01
K021635 KARATS MULTIPURPOSE SOLUTION Ciba Vision Corporation LPN Class II 2002-10-28
K023245 BLOOD FLOW ANALYZER (BFA), MODEL 408-100-01 Paradigm Medical Industries, Inc. NJJ Class II 2002-10-21
K023249 ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM Alcon Laboratories, Inc. NCF Class I 2002-10-18
K023092 BD K-4000 MICROKERATOME SYSTEM Becton, Dickinson & CO HMY Class I 2002-10-18
K022637 BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME Becton, Dickinson & CO HMY Class I 2002-10-16
K022716 MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLB Med-Logics, Inc. HNO Class I 2002-10-11
K021937 TGDC-01 PRA Truevision Instruments HKX Class II 2002-10-11
K013805 KOWA AUTOMATED TONOMETER KT-500 Kowa Optimed, Inc. HKX Class II 2002-10-11
K021752 FP(HEXAFOCON A)RGP CONTACT LENS SPHERICAL/ASP(HEXAFOCON A)RGP CONTACT LENS ASPHERICAL Lucid Korea Co., Ltd. HQD Class II 2002-10-11
K023221 CONTACT LASER & DIAGNOSTIC LENSES Volk Optical, Inc. HJK Class II 2002-10-11
K022373 CHROMAGEN V3.0 READING AID & COLOR DISCRIMINATION ENHANCEMENT SPECTACLE LENS Cantor & Nissel , Ltd. NJH Class I 2002-10-07
K022205 DISPOSABLE N-PE MICROKERATOME BLADES Oasis Medical, Inc. HNO Class I 2002-10-03
K022560 M2 SINGLE USE MICROKERTOME Moria SA HMY Class I 2002-09-27
K023045 MICRORUPTER V Meridian AG LXS Class II 2002-09-26
K021248 ICASE Ikeeps, Inc. LRX Class II 2002-09-24
K022413 LUNEAU 3 MIRROR LENS Luneau SA HJK Class II 2002-09-24
K021977 HYBRID FS & HYBRID FS TORIC (HYCOFOCON A) RGP CONTACT LENS FOR DAILY WEAR Contamac, Ltd. HQD Class II 2002-09-12
K022833 BENJAMIN ENVOY PHACO HANDPIECE Benjamin Biomedical, Inc. HQC Class II 2002-09-09
K021907 IGEL 55 TORIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR Igel Vision Care Pte , Ltd. LPL Class II 2002-09-04
K013756 ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES) Argus Biomedical Pty, Ltd. HQM Class II 2002-08-29
K022128 BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS Bausch & Lomb, Incorporated HQD Class II 2002-08-22
K021720 MULTIVISION METHAFILCON A SOFT (HYDROPILIC) MULTIFOCAL LENS FOR DAILY WEAR Soflex Isralens Contact Lens , Ltd. LPL Class II 2002-08-12
K021143 OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION Alcon Universal, Ltd. LPN Class II 2002-08-08
K021538 LIGHTLAS 810 INFRARED LASER PHOTOCOAGULATOR Lightmed Corp. HQF Class II 2002-08-08
K022054 F 900 C.S.O. S.R.L. HKY Class II 2002-08-06
K021357 MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT Porex Surgical, Inc. HPZ Class II 2002-08-05
K022164 ZETA DIAGNOSTIC RETINAL IMAGING SYSTEM Zeta Development Laboratories HKI Class II 2002-07-26
K020527 HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030 American Optisurgical, Inc. HQC Class II 2002-07-09
K021566 INFINITI Alcon Laboratories, Inc. HQC Class II 2002-07-02
K021640 HANSATOME EXCELLUS MICROKERATOME Bausch & Lomb, Inc. HNO Class I 2002-06-19
K020389 BIOMEDICS 52 (OCUFILCON B) UV BLOCKING DAILY WEAR SOFT CONTACT LENS Ocular Sciences MVN Class II 2002-06-04
K020855 IGEL 55UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IGEL 55 UV MULTIFOCAL (METHAFILCON A) SOFT Igel Vision Care Pte , Ltd. LPL Class II 2002-06-04
K021295 SAVIEW TORIC 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR St. shine Optical Co., Ltd. LPL Class II 2002-06-04
K020802 RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION Bausch & Lomb, Incorporated LYL Class II 2002-05-31
K013646 ROSE K POST GRAFT LENS Rose K International , Ltd. HQD Class II 2002-05-30
K020642 SOFT K. AND SOFT K. TORIC (XYLOFICON A) SOFT (HYDROPHILLIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR Soflex Contact Lens Industries , Ltd. LPL Class II 2002-05-24
K020734 SURGE-FREE ASPIRATION ADAPTER Staar Surgical Co. HQC Class II 2002-05-16
K020608 HD/HDT, (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS) Poly Vue Technolgies, Inc. LPL Class II 2002-05-16
K020927 BAUSCH & LOMB SOFLENS MULTIFOCAL (POLYMACON) VISIBILITY TINTED CONTACT LENS Bausch & Lomb LPL Class II 2002-05-16
K012132 CHROMAGEN V3.0 READING AID SOFT CONTACT LENS Cantor & Nissel , Ltd. NIC Class II 2002-05-09
K020917 SAVIEW 55F (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR St. shine Optical Co., Ltd. LPL Class II 2002-05-06
K020374 OCULIGHT SL/SLX Iridex Corp HQF Class II 2002-05-03
K020930 MENICON PROGENT REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES Menicon Co, Ltd. MRC Class II 2002-05-02
K020911 MID LABS AUTONOMOUS VIT ENHANCER (AVE) Medical Instrument Development Laboratories, Inc. HQE Class II 2002-04-29
K020690 OCU-FLEX-53 CUSTOM PROSTHETIC (OCUFILCON B) SOFT CONTACT LENS Ocu-Ease Optical Products, Inc. LPL Class II 2002-04-26
K020392 FREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHLIC) CONTACT LENS FOR DAILY WEAR CooperVision, Inc. LPL Class II 2002-04-26
K013310 PVS BASIC 2; EPIC 2 Paragon Vision Sciences HQD Class II 2002-04-25
K020079 BLADEWORKS MICROKERATOME BLADE, MODEL 7061 Blade Works, Inc. HNO Class I 2002-04-19
K014274 NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000 Nidek, Inc. HKI Class II 2002-04-17
K020139 FOCUS EXCELENS (LOTRAFILCON B) SPHERICAL, TORIC AND MULTIFOCAL DESIGN Ciba Vision Corporation LPL Class II 2002-04-09
K013204 AQUIFY LENS COMFORT DROPS Ciba Vision Corporation MRC Class II 2002-04-03
K013762 RIGID GAS PERMEABLE CONTACT LENS Bausch & Lomb, Incorporated HQD Class II 2002-04-03
K020006 DYNA INTRA-LIMBAL LENS Lens Dynamics, Inc. HQD Class II 2002-03-29
K012852 EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS Optonol, Ltd. KYF Class II 2002-03-26

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