FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Ophthalmic ×
5,110 results
1081–1104 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jan 13, 2009
TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF...
K072971 · OBO
Topcon Medical Systems, Inc.
Ophthalmic · 449d
Cleared Jan 05, 2009
ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS
K081877 · HQC
Dutch Ophthalmic Research Center...
Ophthalmic · 187d
Cleared Jan 05, 2009
BAUSCH & LOMB STELLARIS MICROSURGICAL SYSTEM
K082473 · HQC
Bausch & Lomb, Inc.
Ophthalmic · 131d
Cleared Dec 17, 2008
POLYVUE 55 SINGLE VISION, TORIC AND MULTIFOCAL SOFT (HYDROPHILIC) CONTACT...
K080794 · LPL
Polyvue Distribution, Inc.
Ophthalmic · 272d
Cleared Dec 15, 2008
CENEFOM PVA SURGICAL SPEAR
K082460 · HOZ
Longtek Scientific Co., Ltd.
Ophthalmic · 111d
Cleared Nov 18, 2008
NON-CONTACT TONOMETER, MODEL FT-1000
K073087 · HKX
Tomey Corporation
Ophthalmic · 383d
Cleared Nov 14, 2008
SPECTRAL OCT/SLO
K080460 · OBO
Opko Health, Inc.
Ophthalmic · 268d
Cleared Nov 05, 2008
RETCAM 3 OPHTHALMIC IMAGING SYSTEM
K081858 · HKI
Clarity Medical Systems
Ophthalmic · 127d
Cleared Oct 23, 2008
DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786
K081382 · KYB
Duckworth & Kent, Ltd.
Ophthalmic · 160d
Cleared Oct 21, 2008
KOWA NONMYD ALPHA-DIII
K082767 · HKI
Kowa Co. , Ltd.
Ophthalmic · 29d
Cleared Oct 16, 2008
CRYSTALSERT CRYSTALENS DELIVERY SYSTEM
K082944 · MSS
Bausch & Lomb, Inc.
Ophthalmic · 14d
Cleared Oct 15, 2008
CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS
K080632 · MVN
Clearlab SG Pte, Ltd.
Ophthalmic · 224d
Cleared Oct 09, 2008
OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT...
K081178 · HQD
Contamac, Ltd.
Ophthalmic · 167d
Cleared Oct 08, 2008
VITRECTOMY CUTTER AND ACCESSORIES
K081681 · MLZ
Advanced Medical Optics, Inc.
Ophthalmic · 113d
Cleared Oct 02, 2008
ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30
K081545 · MSS
Advanced Medical Optics, Inc.
Ophthalmic · 122d
Cleared Sep 30, 2008
IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR...
K082364 · NFJ
Topcon Corp.
Ophthalmic · 43d
Cleared Sep 29, 2008
PROCLEAR MULTIFOCAL TORIC AND XR AND TORIC XR
K081865 · LPL
CooperVision, Inc.
Ophthalmic · 90d
Cleared Sep 23, 2008
MENICON Z RIGID GAS PERMEABLE CONTACT LENS
K081443 · HQD
Menicon Co, Ltd.
Ophthalmic · 124d
Cleared Sep 22, 2008
VISUAL PHACOEMULSIFICATION SYSTEM, MODEL 551
K080803 · HQC
American Optisurgical, Inc.
Ophthalmic · 185d
Cleared Sep 12, 2008
SOLX 790 TITANIUM SAPPHIRE LASER
K081774 · HQF
Solx, Inc.
Ophthalmic · 81d
Cleared Sep 11, 2008
PARKONE
K073508 · MXK
Oculus Optikgerate GmbH
Ophthalmic · 273d
Cleared Sep 11, 2008
SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS
K081704 · GEX
Lumenis, Inc.
Ophthalmic · 86d
Cleared Sep 11, 2008
CVUE ADVANCED (HIOXIFILCON D) SOFT (HYDROPHILIC) CONTACT LENS
K082393 · LPL
Unilens Corp., USA
Ophthalmic · 23d
Cleared Sep 09, 2008
GILRAS SLIT LAMP, MODELS GR-SL7, GR-SL36, GR-SL54 AND GR-SL72
K080776 · HJO
Us Ophthalmic, LLC
Ophthalmic · 174d