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
1993–2016 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Dec 08, 1997
AL-47 TORIC (ISOFILCON) SOFT (TORIC) DAILY WEAR CONTACT LENS
K973847 · LPL
Martin Dalsing
Ophthalmic · 61d
Cleared Dec 08, 1997
AL-47 (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR &...
K973967 · LPL
Alden Optical Labs., Inc.
Ophthalmic · 52d
Cleared Dec 08, 1997
MULTI
K974414 · HQY
Morning Calm Corp.
Ophthalmic · 14d
Cleared Dec 02, 1997
ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 90746
K973332 · LPN
Alcon Laboratories
Ophthalmic · 89d
Cleared Dec 01, 1997
NON-PRESCRIPTION SUNGLASSES
K974179 · HQY
Taipan Optical Company , Ltd.
Ophthalmic · 25d
Cleared Nov 25, 1997
WHITTINGHAM ULTRACLEAN PHACO HANDPIECE
K972063 · HQC
William F. Whittingham
Ophthalmic · 175d
Cleared Nov 25, 1997
D.O.R.C. HEXON ILLUMINATION SYSTEM
K973229 · MPA
Dutch Ophthalmic USA, Inc.
Ophthalmic · 90d
Cleared Nov 24, 1997
BOSTON LIQUID ENZYMATIC CLEANER
K973217 · LPN
Polymer Technology Corp.
Ophthalmic · 89d
Cleared Nov 21, 1997
LUXSCOPE
K973193 · HQF
Luxtec Corp.
Ophthalmic · 88d
Cleared Nov 20, 1997
FLEXLENS, FLEXLENS TORIC
K973192 · LPL
Specialty Ultravision, Inc.
Ophthalmic · 87d
Cleared Nov 20, 1997
AL-47 (ISOFILCON) SOFT (SPHERICAL) DAILY WEAR CONTACT LENS
K973597 · LPL
Martin Dalsing
Ophthalmic · 59d
Cleared Nov 20, 1997
VENNETO
K974045 · HQY
Amsure Sports, Inc.
Ophthalmic · 27d
Cleared Nov 18, 1997
SYNTEC TRUE LIGHT END IRRIGATING ENDOILLUMINATOR
K973293 · MPA
Vaughan Weeks
Ophthalmic · 77d
Cleared Nov 18, 1997
SUNGLASSES
K973934 · HQY
Elegance Optical Manufactory, Ltd.
Ophthalmic · 34d
Cleared Nov 14, 1997
SYNTEC TRUE LIGHT ENDOILLUMIINATOR WITH PICK
K973290 · MPA
Vaughan Weeks
Ophthalmic · 73d
Cleared Nov 13, 1997
EYE SYS VISTA
K973756 · HLQ
Eyesys Technologies, Inc.
Ophthalmic · 42d
Cleared Nov 07, 1997
D.O.R.C. SOLUX LIGHT SOURCE
K973757 · MPA
Dutch Ophthalmic USA, Inc.
Ophthalmic · 36d
Cleared Nov 04, 1997
NIDEK HANDY
K973218 · HKI
Nidek, Inc.
Ophthalmic · 69d
Cleared Nov 04, 1997
RODENSTOCK LASER SLITLAMP
K973220 · HQF
G. Rodenstock Instrumente GmbH
Ophthalmic · 69d
Cleared Nov 04, 1997
NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF)
K973533 · HKI
Nidek, Inc.
Ophthalmic · 47d
Cleared Oct 24, 1997
HANSATOME MICROKERATOME
K972808 · HNO
Chiron Vision Corp.
Ophthalmic · 88d
Cleared Oct 16, 1997
MOA BONE / M-SPHERE
K972143 · HPZ
Iop, Inc.
Ophthalmic · 132d
Cleared Oct 16, 1997
SUNGLASSES
K973526 · HQY
Pyramid Handbags, Inc.
Ophthalmic · 28d
Cleared Oct 15, 1997
(LENSES)BENZ HEFILCON A SPHERICAL/TORIC SOFT (HYDROPHILIC) CONTACT LENSES IN...
K972807 · LPL
Benz Research and Development Corp.
Ophthalmic · 79d