meddevicedb.com FDA Device Reference

Review Panel

Ophthalmic FDA 510(k) Clearances & Devices

Cleared Devices
4,756
Product Codes (page)
29
Latest Decision
2004-10-28

Clearances · page 13 of 48

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K042275 VISTAKON (SENOFILCON A) SOFT CONTACT LENS Vistakon LPL Class II 2004-10-28
K042810 CENTURION SES EPIKERATOME Norwood Abbey , Ltd. HNO Class I 2004-10-28
K031753 KARATS MULTIPURPOSE SOLUTION Ciba Vision Corporation LPN Class II 2004-10-28
K042435 COOPER PROSTHETIC CooperVision, Inc. LPL Class II 2004-10-26
K040839 COMPLETE BLINK-N-CLEAN LENS DROPS Advanced Medical Optics, Inc. MRC Class II 2004-10-19
K042742 HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM) Heidelberg Engineering MXK Class II 2004-10-13
K041110 MB 105 MILLENNIUM BLADES Millennium Biomedical, Inc. HNO Class I 2004-10-13
K041019 THE FUGO BLADE FOR GLAUCOMA Medisurg , Ltd. NCR Class II 2004-10-08
K042001 PANORAMIC 200A Optos Plc. HLI Class II 2004-10-07
K041598 LASEREX, MODEL LP4532 Ellex Medical Pty, Ltd. HQF Class II 2004-10-06
K040209 IRIS MEDICAL IQ 810 PHOTOCOAGULATOR Iridex Corp HQF Class II 2004-09-20
K033599 ONSI -56 (ONSIFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS The Lagado Corp. HQD Class II 2004-09-16
K042242 ALDEN HP (HIOXIFILCON B) SPHERE & TORIC SOFT CONTACT LENSES Alden Optical Labs., Inc. LPL Class II 2004-09-15
K041206 EPITOME SYSTEM Gebauer Medizintechnik GmbH HNO Class I 2004-09-15
K031788 PATHFINDER Massie Research Laboratories, Inc. MXK Class II 2004-09-02
K032910 CARRIAZO PENDULAR Schwind Eye-Tech-Solutions GmbH & Co. KG HNO Class I 2004-08-30
K041998 PHACO CHOP NEEDLES Bausch & Lomb, Inc. HQC Class II 2004-08-16
K041700 CANTOR & NISSEL HAND PAINTED PROSTHETIC SOFT CONTACT LENS FOR DAILY WEAR Cantor & Nissel , Ltd. LPL Class II 2004-07-30
K033655 SOFLEX SOFT K (XYLOFILCON A) SOFT (HYDROPHILIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR Soflex Contact Lens Industries , Ltd. LPL Class II 2004-07-30
K040913 NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT) Bausch & Lomb MXK Class II 2004-07-23
K041138 LEO COLORS, LEO ASPHERIC COLORS, LEO TORIC COLORS CooperVision, Inc. LPL Class II 2004-07-23
K040851 MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM Porex Surgical, Inc. HPZ Class II 2004-07-16
K041608 C-VUE 55 TORIC (METHAFILCON A) MULTIFOCAL CONTACT LENS Unilens Corp., USA LPL Class II 2004-07-07
K033949 VARILUX VISIONPRINT SYSTEM (VPS) Essilor Intl. HLL Class II 2004-07-02
K041546 DIGITAL FUNDUS CAMERA, MODEL CF-60DSI Canon, Inc. HKI Class II 2004-06-23
K032836 M3 MICROKERATOME Moria SA HNO Class I 2004-06-18
K040837 MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE Medicel AG MSS Class I 2004-06-17
K040900 S-42 UV, T-42 UV TORIC AND M-42 UV MULTIFOCAL (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR Optical Connection, Inc. LPL Class II 2004-06-15
K032412 RE-USEABLE MICROSTAAR INJECTOR, MSI-S Staar Surgical Co. KYB Class I 2004-06-10
K040689 EYE SPHERE IMPLANTS Oculo Plastik, Inc. HPZ Class II 2004-06-10
K040914 POLYVIAL/POLYPAK, CONTACT LENS CASE AND STORAGE SYSTEM CONTAINER FOR OPHTHALMICS Exero Products, Inc. LRX Class II 2004-05-27
K033457 M2 COMPATIBLE MICROKERATOME BLADE Micro Specialties, Inc. HNO Class I 2004-05-25
K041290 RTA MODEL D RETINAL THICKNESS ANALYZER Talia Technology , Ltd. HLI Class II 2004-05-24
K033123 STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASE Carl Zeiss Meditec, Inc. HLI Class II 2004-04-20
K040297 ONEUSE- PLUS MICROKERATOME Moria SA HMY Class I 2004-03-31
K033236 PRIZM KERATOME BLADE, MODEL MK8512M2 Surgin Surgical Instrumentation, Inc. HNO Class I 2004-03-26
K040204 ZYOPTIX XP MICROKERATOME Bausch & Lomb, Inc. HNO Class I 2004-03-22
K033594 OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES Contamac, Ltd. HQD Class II 2004-03-19
K040373 KERATO ANALYZER (EKA) Konan Medical, Inc. NQE Class II 2004-03-19
K033919 CIBA VISION (LOTRAFILCON B) SPHERICAL, TORIC, MULTIFOCAL AND TORIC MULTIFOCAL DESIGNS Ciba Vision Corporation LPL Class II 2004-03-12
K040325 PANORET, MODEL PNM 60 Medibell Medical Vision Technologies , Ltd. HKI Class II 2004-03-08
K033136 I-LUX INNOVA BLUE TINT LENS, MODEL SUPER O2 Innova Vision, Inc. LPL Class II 2004-03-05
K033950 DORC VITRECTOMY LENSES, MODEL 1284 SERIES Dutch Ophthalmic Research Center (D.O.R.C.) HJK Class II 2004-02-20
K031774 HORIZON (METHAFILCON A) DAILY WEAR SPHERE AND TORIC CONTACT LENSES Westcon Contact Lens Co., Inc. LPL Class II 2004-02-20
K033941 MILLENNIUM MICROSURGICAL SYSTEM AND PERISTALTIC PHACO PACK Bausch & Lomb, Inc. HQF Class II 2004-02-10
K033969 ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER Vistakon LPL Class II 2004-02-04
K033656 SAUFLON FLAT LENS CASE/SAUFLON 2003 BARREL LENS CASE Sauflon Pharmaceuticals, Ltd. LRX Class II 2004-02-02
K033608 AQUIFY MULTI-PURPOSE SOLUTION Ciba Vision Corporation LPN Class II 2004-02-02
K033182 PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD Surgin Surgical Instrumentation, Inc. HNO Class I 2004-01-30
K032799 NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER Reichert, Inc. HKX Class II 2004-01-20
K033293 MED-LOGICS, MODEL ML7090 Med-Logics, Inc. HNO Class I 2004-01-13
K023506 SURGICAL MEDICAL DEVICE CAUTERY Modern Medical Equipment Mfg., Ltd. HQP Class II 2004-01-13
K031831 TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM Topcon Medical Systems, Inc. HKO Class I 2003-12-19
K033653 VENTURI PHACO PACK Bausch & Lomb, Inc. HQC Class II 2003-12-17
K033701 FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES ONE-DAY SOFT CONTACT LENSES Ciba Vision Corporation MVN Class II 2003-12-15
K032104 AMNIOLENS Bio-Tissue, Inc. NQB Class II 2003-12-12
K033190 VISION-TECH YZ SLIT LAMP, MODEL 66 Suzhou 66 Vision-Tech Co., Ltd. HJO Class II 2003-12-04
K031733 NON-CONTACT TONOMETER, MODEL NT-4000 Nidek, Inc. HKX Class II 2003-12-04
K032309 NOVELENS CONTACT LENS CLEANING ENHANCEMENT AND STORAGE ACCESSORY Novelens, Inc. LRX Class II 2003-12-04
K032087 KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004 Keeler Instruments, Inc. HLJ Class II 2003-11-26
K032967 PASCAL DYNAMIC CONTOUR TONOMETER Smt Swiss Microtechnology AG HKY Class II 2003-11-14
K031646 BAUSCH & LOMB MULTI-PURPOSE SOLUTION NRC03 Bausch & Lomb, Inc. LPN Class II 2003-11-14
K032873 PROCLEAR COMPATIBLES MULTIFOCAL CooperVision, Inc. LPL Class II 2003-11-07
K033390 COLIBRI DISPOSABLE VITRECTOMY CUTTER Microworld Medical Instruments, Inc. HQE Class II 2003-11-04
K032481 THERATEARS CONTACT LENS COMFORT DROPS Advanced Vision Research, Inc. LPN Class II 2003-11-04
K032978 MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME Ciba Vision Corporation HNO Class I 2003-10-20
K032340 VISTAKON (GALYFILCON A) SOFT CONTACT LENS Johnson & Johnson Vision Care, Inc. LPL Class II 2003-10-16
K030910 CLUED UP MULTIPURPOSE SOLUTION- NO RUB Clued UP Limited LPN Class II 2003-10-10
K024072 DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM Duckworth & Kent, Ltd. MSS Class I 2003-10-06
K032030 BLINK CL LUBRICANT EYE DROPS Advanced Medical Optics, Inc. LPN Class II 2003-09-25
K030393 OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER Haag-Streit Holding AG MXK Class II 2003-09-25
K032769 EYESOPEN TONOMETER Eye-Deas, LLC HKY Class II 2003-09-23
K030719 PENTACAM SCHEIMPFLUG CAMERA Oculus Optikgerate GmbH MXK Class II 2003-09-16
K030522 AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION Ciba Vision Corporation LPN Class II 2003-09-12
K032256 QUASAR-QUASAR PLUS-QUASAR TORIC (HYBUFOCON A, HEXAFOCON A, PAFLUFOCON B) RIGID GAS PERMEABLE (RGP) DAILY WEAR CONTACT LE No 7 Contact Lens Laboratory , Ltd. LPL Class II 2003-08-29
K031665 IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS Iridex Corp HQF Class II 2003-08-27
K032297 DISPOSABLE N-PE MICKROKERATOME BLADES Oasis Medical, Inc. HNO Class I 2003-08-26
K023400 FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT Fci Ophthalmics, Inc. HPZ Class II 2003-08-22
K031735 CENTURION SES EPIKERATOME Ciba Vision Corporation HNO Class I 2003-08-21
K030957 PERFECT CAPSULE Milvella Pty. , Ltd. HQC Class II 2003-08-20
K031957 MODIFICATION TO KARATS MULTI-PURPOSE SOLUTION Ciba Vision Corporation LPN Class II 2003-08-14
K031549 SOLID STATE LAMP [LED] HEADLIGHT Welch Allyn, Inc. FSR Class II 2003-08-11
K031548 LED HEADLIGHT Welch Allyn, Inc. FSR Class II 2003-08-11
K031532 SATUREEYES II (ACOFILCON A), (ACOFILCON B) & (TETRAFILCON A) SOFT CONTACT LENS FOR DAILY WEAR Metro Optics of Austin, Inc. LPL Class II 2003-08-01
K030278 SAUFLON MULTIPURPOSE SOLUTION - NO RUB Sauflon Pharmaceuticals, Ltd. LPN Class II 2003-07-30
K031477 HYDROGENICS 2.0 60 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS Ocular Sciences, Inc. LPL Class II 2003-07-18
K023737 INJECTOR Anton Meyer & Co. , Ltd. MSS Class I 2003-07-14
K031193 SOFT (HYDROPHILIC) CONTACT LENS CARE SOLUTION Alcon, Inc. LPN Class II 2003-07-03
K031023 PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10 Peregrine Surgical , Ltd. HQF Class II 2003-06-27
K031521 AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION Ciba Vision Corporation LPN Class II 2003-06-27
K031522 SOLO-CARE PLUS MULTIPURPOSE SOLUTION Ciba Vision Corporation LPN Class II 2003-06-27
K030401 DISPOSABLE M2-PE MICROKERATOME BLADES Oasis Medical, Inc. HNO Class I 2003-06-19
K030891 SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK Surgistar, Inc. HNO Class I 2003-06-17
K030948 VMATE MODEL VMM1000 Howard Instruments, Inc. HQE Class II 2003-06-17
K030987 CONTACT LENS STORAGE CASE Pelican Products LRX Class II 2003-06-12
K030842 ENI-EYE Q TORIC (ACOFILCON) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR, ENI-EYE (ACOFILCON) SOFT (HYDROP Soflex Contact Lens Industries , Ltd. LPL Class II 2003-06-06
K031629 CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI Canon USA, Inc. HKI Class II 2003-06-06
K030593 FLEXLENS AND HARRISON POST REFRACTIVE SURGERY (BIOXIFILCON A), (HIOXIFILCON B), (ACOFILCON A), (ACOFILCON B) SOFT CONTAC X-Cel Contacts, A Walman Co. LPL Class II 2003-05-30
K031404 DIGNITY OPHTHALMIC SURGICAL SYSTEM Phacor Inc., A Santen Company HQC Class II 2003-05-22
K030748 AQUASOFT (OCUFILCON D) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH UV BLOCKER Clearlab Pte , Ltd. LPL Class II 2003-05-14

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