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
1489–1512 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Sep 09, 2002
BENJAMIN ENVOY PHACO HANDPIECE
K022833 · HQC
Benjamin Biomedical, Inc.
Ophthalmic · 14d
Cleared Sep 04, 2002
IGEL 55 TORIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
K021907 · LPL
Igel Vision Care Pte , Ltd.
Ophthalmic · 86d
Cleared Aug 29, 2002
ALPHACOR
K013756 · HQM
Argus Biomedical Pty, Ltd.
Ophthalmic · 289d
Cleared Aug 22, 2002
BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS
K022128 · HQD
Bausch & Lomb, Incorporated
Ophthalmic · 52d
Cleared Aug 12, 2002
MULTIVISION METHAFILCON A SOFT (HYDROPILIC) MULTIFOCAL LENS FOR DAILY WEAR
K021720 · LPL
Soflex Isralens Contact Lens , Ltd.
Ophthalmic · 80d
Cleared Aug 08, 2002
OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION
K021143 · LPN
Alcon Universal, Ltd.
Ophthalmic · 121d
Cleared Aug 08, 2002
LIGHTLAS 810 INFRARED LASER PHOTOCOAGULATOR
K021538 · HQF
Lightmed Corp.
Ophthalmic · 90d
Cleared Aug 06, 2002
F 900
K022054 · HKY
C.S.O. S.R.L.
Ophthalmic · 43d
Cleared Aug 05, 2002
MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT
K021357 · HPZ
Porex Surgical, Inc.
Ophthalmic · 98d
Cleared Jul 26, 2002
SHARPOINT ULTRAPLUG EXTENDED WEAR PLUG
K020882 · LZU
Surgical Specialties Corp
Ophthalmic · 130d
Cleared Jul 26, 2002
ZETA DIAGNOSTIC RETINAL IMAGING SYSTEM
K022164 · HKI
Zeta Development Laboratories
Ophthalmic · 23d
Cleared Jul 09, 2002
HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030
K020527 · HQC
American Optisurgical, Inc.
Ophthalmic · 140d
Cleared Jul 02, 2002
INFINITI
K021566 · HQC
Alcon Laboratories, Inc.
Ophthalmic · 50d
Cleared Jul 01, 2002
OPAQUE HERRICK LACRIMAL PLUG, 0.3MM,0.5MM,0.7MM, MODELS...
K021831 · LZU
Lacrimedics, Inc.
Ophthalmic · 27d
Cleared Jun 27, 2002
SOFT PLUG ABSORBABLE PLUG-SA
K013613 · LZU
Oasis Medical, Inc.
Ophthalmic · 234d
Cleared Jun 21, 2002
VISUCAM
K021787 · NFF
Carl Zeiss Ophthalmic Systems, Inc.
Ophthalmic · 22d
Cleared Jun 19, 2002
HANSATOME EXCELLUS MICROKERATOME
K021640 · HNO
Bausch & Lomb, Inc.
Ophthalmic · 30d
Cleared Jun 04, 2002
BIOMEDICS 52 (OCUFILCON B) UV BLOCKING DAILY WEAR SOFT CONTACT LENS
K020389 · MVN
Ocular Sciences
Ophthalmic · 119d
Cleared Jun 04, 2002
IGEL 55UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IGEL...
K020855 · LPL
Igel Vision Care Pte , Ltd.
Ophthalmic · 81d
Cleared Jun 04, 2002
SAVIEW TORIC 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR
K021295 · LPL
St. shine Optical Co., Ltd.
Ophthalmic · 41d
Cleared May 31, 2002
RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION
K020802 · LYL
Bausch & Lomb, Incorporated
Ophthalmic · 80d
Cleared May 30, 2002
ROSE K POST GRAFT LENS
K013646 · HQD
Rose K International , Ltd.
Ophthalmic · 206d
Cleared May 24, 2002
SOFT K. AND SOFT K. TORIC (XYLOFICON A) SOFT (HYDROPHILLIC) KERATOCONUS...
K020642 · LPL
Soflex Contact Lens Industries , Ltd.
Ophthalmic · 86d
Cleared May 16, 2002
HD/HDT, (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY...
K020608 · LPL
Poly Vue Technolgies, Inc.
Ophthalmic · 80d