Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Ophthalmic ×
5,119 results
1249–1272 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jan 30, 2006
BOSTON ES (ENFLUFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON XO (HEXAFOCON...
K053124 · HQD
Bausch & Lomb, Incorporated
Ophthalmic · 84d
Cleared Jan 30, 2006
DUCKWORTH & KENT LTD CARTRIDGE LENS DELIVERY SYSTEM, MODEL DK7797
K053176 · MSS
Duckworth & Kent, Ltd.
Ophthalmic · 77d
Cleared Jan 24, 2006
OPTO GLOBAL DIGITAL FUNDUS CAMERA SYSTEM MODEL ADS 1.5
K053044 · HKI
Opto Global, Inc.
Ophthalmic · 88d
Cleared Jan 19, 2006
C-FLEX SYSTEM SINGLE USE DISPOSABLE INJECTOR, MODEL R-INJ-02
K052651 · MSS
Rayner Surgical, Inc.
Ophthalmic · 115d
Cleared Jan 13, 2006
HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT)
K052935 · MXK
Heidelberg Engineering
Ophthalmic · 86d
Cleared Jan 09, 2006
PRECISION OPTICS CORPORATION VIDEO OPHTHALMOSCOPE, MODEL 2500-VOS
K053425 · HLJ
Precision Optics Corp.
Ophthalmic · 32d
Cleared Dec 15, 2005
MARIETTA CONTACT LENS (POLYMACON), TINTED DAILY WEAR CONTACT LENS
K052606 · LPL
Marietta Vision
Ophthalmic · 84d
Cleared Dec 09, 2005
FUGO BLADE FOR PERIPHERAL IRIDOTOMY, MODEL M300
K050933 · NCR
Medisurg , Ltd.
Ophthalmic · 239d
Cleared Dec 06, 2005
BIOFINITY (COMFILCON A) SOFT CONTACT LENS
K052560 · LPL
CooperVision, Inc.
Ophthalmic · 81d
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