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
3025–3048 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Dec 08, 1993
SUNGLASSES
K925539 · HQY
Sunshine Opticians, Inc.
Ophthalmic · 401d
Cleared Dec 08, 1993
SPECTACLE FRAME
K930331 · HQZ
Australian Optical Co., Inc.
Ophthalmic · 320d
Cleared Dec 08, 1993
SPECTACLE FRAMES
K934301 · HQZ
Gernot Lindner, Lunor-Vertrieb
Ophthalmic · 97d
Cleared Dec 08, 1993
SUNGLASSES (NON-PRESCRIPTION)
K934374 · HQY
Immmex Company , Ltd.
Ophthalmic · 92d
Cleared Dec 08, 1993
SUNGLASSES
K934403 · HQY
Sun Share Merchandise Corp.
Ophthalmic · 90d
Cleared Dec 08, 1993
SPECTACLE FRAME
K934463 · HQZ
Good Bond Industrial Corp.
Ophthalmic · 89d
Cleared Dec 08, 1993
FINE OPTICS
K934797 · HQZ
Fine Optics, Inc.
Ophthalmic · 63d
Cleared Dec 08, 1993
SUNGLASSES
K934837 · HQY
Simon Marketing, Inc.
Ophthalmic · 64d
Cleared Dec 08, 1993
COOL KIDS HIP SHADES
K934852 · HQY
Ja-Ru, Inc.
Ophthalmic · 57d
Cleared Dec 08, 1993
FRAME SPECTACLE
K934858 · HQZ
Arno Intl., Inc.
Ophthalmic · 57d
Cleared Dec 06, 1993
MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTE
K925921 · KYG
Site Microsurgical Systems, Inc.
Ophthalmic · 378d
Cleared Dec 06, 1993
OCUSYSTEM IIE
K926381 · HQC
Surgeon Design
Ophthalmic · 349d
Cleared Dec 03, 1993
DE LUXE
K925755 · HLJ
Rudolf Riester GmbH & Co. KG
Ophthalmic · 385d
Cleared Nov 22, 1993
ROTA SYSTEM XL
K931839 · HMF
Rota Systems Medfurniture, Inc.
Ophthalmic · 223d
Cleared Nov 22, 1993
NIDEK MODEL AC-2300
K932836 · HQF
Nidek, Inc.
Ophthalmic · 164d
Cleared Nov 12, 1993
OPTOSCALPEL I LASER SYSTEM
K923531 · HQB
Optomed Corp.
Ophthalmic · 484d
Cleared Nov 12, 1993
AHMED GLAUCOMA VALVE IMPLANT
K925636 · KYF
New World Medical, Inc.
Ophthalmic · 368d
Cleared Nov 12, 1993
SUNGLASSES
K930585 · HQY
Daiko S.R.L.
Ophthalmic · 281d
Cleared Nov 12, 1993
GOGGLE SAFEGUARD
K931254 · HOY
Sellstrom Mfg. Co.
Ophthalmic · 245d
Cleared Nov 12, 1993
SITE'S CD II PHACOEMULSIFICATION HANDPIECE
K931866 · HQC
Site Microsurgical Systems, Inc.
Ophthalmic · 212d
Cleared Nov 12, 1993
JR -- OPHTHALMIC ARGON LASER
K932296 · HQF
Carson Laserworks
Ophthalmic · 185d
Cleared Nov 12, 1993
MODIFICATION OF SURGICAL EYESHIELD MASK
K934085 · HOY
American Threshold Industries, Inc.
Ophthalmic · 84d
Cleared Nov 12, 1993
REVO CLASSIC/SHAPES SUNGLASSES
K934400 · HQY
Revo, Inc.
Ophthalmic · 64d
Cleared Nov 02, 1993
GLASSES
K931451 · HQY
Siegel Optik
Ophthalmic · 224d