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
1249–1272 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Nov 30, 2005
SYNERGEYES KC (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENS FOR...
K052675 · HQD
Synergeyes
Ophthalmic · 64d
Cleared Nov 10, 2005
ALDEN CLASSIC (POLYMACON) MULTIFOCAL (SPHERICAL AND TORIC), ALDEN CLASSIC 55...
K052703 · LPL
Alden Optical Labs., Inc.
Ophthalmic · 43d
Cleared Nov 10, 2005
KOWA NONMYD 7, KOWA NONMYD A-D
K053026 · HKI
Kowa Co. , Ltd.
Ophthalmic · 14d
Cleared Nov 03, 2005
KOWA GENESIS-D HAND-HELD RETINAL CAMERA
K050271 · HKI
Kowa Co. , Ltd.
Ophthalmic · 272d
Cleared Nov 02, 2005
VISUCAM PRO NM
K052268 · HKI
Carl Zeiss Meditec, AG
Ophthalmic · 75d
Cleared Nov 02, 2005
TYRO 97 (HOFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND...
K052507 · HQD
The Lagado Corp.
Ophthalmic · 50d
Cleared Nov 02, 2005
SAUFLON FLAT COLOURED LENS CASE
K052809 · LRX
Sauflon Pharmaceuticals, Ltd.
Ophthalmic · 29d
Cleared Oct 06, 2005
KOWA VX-10
K043213 · HKI
Kowa Co. , Ltd.
Ophthalmic · 321d
Cleared Sep 30, 2005
VISANTE OCT
K051789 · HLI
Carl Zeiss Meditec, Inc.
Ophthalmic · 91d
Cleared Sep 30, 2005
FAMILY OF SELECTA OPHTHALMIC LASER SYSTEMS (SELECTA 1064, SELECTA SLT,...
K051944 · HQF
Lumenis, Inc.
Ophthalmic · 74d
Cleared Sep 28, 2005
CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA
K051940 · MXK
Sis Ltd., Surgical Instrument Systems
Ophthalmic · 72d
Cleared Sep 23, 2005
REPROCESSED PHACOEMUISIFICATION TIPS
K050518 · NKX
Alliance Medical, Inc.
Ophthalmic · 206d
Cleared Sep 21, 2005
20G SMA LASER FIBER, MODEL LF100
K050807 · HQF
Ophthalmed, LLC
Ophthalmic · 175d
Cleared Sep 14, 2005
ALCON MULTI-PURPOSE DISINFECTING SOLUTION
K050729 · LPN
Alcon Research, Ltd.
Ophthalmic · 177d
Cleared Sep 09, 2005
SOLO-CARE AQUA ANTIMICROBIAL LENS CASE
K041820 · LRX
Ciba Vision Corporation
Ophthalmic · 430d
Cleared Sep 02, 2005
SYNERGEYES (PAFLUCON D HEM-IBERFILCON A) HYBRID CONTACT LENS
K051035 · HQD
Synergeyes
Ophthalmic · 133d
Cleared Sep 01, 2005
JSZ-STAT-TREE, AND JSZ-STAT-OR, CLEANING, DISINFECTING AND STORING SOLUTIONS
K052074 · MRC
Szabocsik and Associates
Ophthalmic · 31d
Cleared Aug 24, 2005
OPD-STATION SOFTWARE
K050336 · NCF
Nidek, Inc.
Ophthalmic · 195d
Cleared Aug 19, 2005
DELTA PUNCTUM PLUG
K050851 · LZU
Delta Life Science, Inc.
Ophthalmic · 137d
Cleared Aug 18, 2005
MICROPULSE PHACOEMULSIFICATION SYSTEM
K051186 · HQC
Trillium Medical, Inc.
Ophthalmic · 101d
Cleared Aug 16, 2005
55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
K051095 · LPL
Optical Connection, Inc.
Ophthalmic · 110d
Cleared Aug 12, 2005
DISCON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
K051129 · LPL
Innova Vision, Inc.
Ophthalmic · 101d
Cleared Aug 12, 2005
ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILITY TINT WITH UV...
K051900 · MVN
Johnson & Johnson Vision Care, Inc.
Ophthalmic · 30d
Cleared Aug 10, 2005
AQUIFY MULTIPURPOSE SOLUTION
K050250 · LPN
Ciba Vision Corporation
Ophthalmic · 188d