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
2161–2184 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jan 09, 1997
RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT
K964338 · HKM
Rudolf Riester GmbH & Co. KG
Ophthalmic · 70d
Cleared Dec 23, 1996
CORNEAL TOPOGRAPHER 200
K963762 · MMQ
Eclipse Ventures
Ophthalmic · 95d
Cleared Dec 20, 1996
VITLITE (TR7700)
K963417 · MPA
Escalon Trek Medical
Ophthalmic · 112d
Cleared Dec 20, 1996
HORIZON/WESTHIN 38 SOFBLU (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR...
K963837 · LPL
Westcon Contact Lens Co., Inc.
Ophthalmic · 87d
Cleared Dec 20, 1996
ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING
K964222 · LYL
Paladin Medical, Inc.
Ophthalmic · 59d
Cleared Dec 20, 1996
PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS
K964774 · LZU
Fci Ophthalmics, Inc.
Ophthalmic · 59d
Cleared Dec 17, 1996
HYDRASOFT (EAST) AND HYDRASOFT TORIC(EAST) (METHAFILCON B) DAILY WEAR SOFT...
K962185 · LPL
CooperVision, Inc.
Ophthalmic · 194d
Cleared Dec 17, 1996
EYE FIXATION SPECULUM
K964289 · HNC
Eyefix, Inc.
Ophthalmic · 50d
Cleared Dec 17, 1996
PLASTIC SUNGLASSES
K964316 · HQY
Medical Reports Exchange, Inc.
Ophthalmic · 49d
Cleared Dec 12, 1996
SUNGLASSES OR MULTIPLE
K964429 · HQY
Trade Resources , Ltd.
Ophthalmic · 37d
Cleared Dec 09, 1996
ML MICROKERATOME BLADE
K962661 · HNO
Med-Logics, Inc.
Ophthalmic · 154d
Cleared Nov 29, 1996
NEW COMFORT CONTACT LENS CARE ACCESSORY
K962112 · LYL
Lens Comfort, Inc.
Ophthalmic · 182d
Cleared Nov 29, 1996
CONTACT LENS WITH COLOR ADDITIVE
K962911 · LPL
Cal Bionics
Ophthalmic · 128d
Cleared Nov 29, 1996
LIFESTYLE FREQUENCY PROGRESSIVE (METHAFILCON A) MULTIFOCAL HYDROPHILIC...
K963011 · LPL
Permeable Technologies, Inc.
Ophthalmic · 119d
Cleared Nov 27, 1996
DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENS
K963487 · LPL
Ciba Vision Corporation
Ophthalmic · 85d
Cleared Nov 26, 1996
MENTOR TONO-PEN 3
K964312 · HKY
Mentor Ophthalmics, Inc.
Ophthalmic · 28d
Cleared Nov 25, 1996
VIT COMMANDER SYSTEM
K961738 · HQE
Scieran Technologies, Inc.
Ophthalmic · 206d
Cleared Nov 25, 1996
VISCOUS FLUID SYSTEM
K963434 · MRH
Escalon Trek Medical
Ophthalmic · 87d
Cleared Nov 25, 1996
SPENSER SUNGLASSES AND SPORT SUNGLASSES
K964058 · HQY
Spencer Products Co.
Ophthalmic · 47d
Cleared Nov 25, 1996
SUNGLASSES
K964082 · HQY
Neo Vu, Inc.
Ophthalmic · 45d
Cleared Nov 25, 1996
SUNGLASSES(NON-PRESCRIPTION)
K964413 · HQY
Ever Prime Enterprises , Ltd.
Ophthalmic · 55d
Cleared Nov 20, 1996
METRO FOCAL ASPHERIC (POLYMACON)
K961606 · LPL
Metro Optics of Austin, Inc.
Ophthalmic · 209d
Cleared Nov 20, 1996
LIFESTYLE GP (TELEFOCON B) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENS FOR...
K963010 · HQD
Permeable Technologies, Inc.
Ophthalmic · 110d
Cleared Nov 20, 1996
SPECIALTY PROGRESSIVE(METHAFILCON A)MULTIFOCAL SOFT(HYDROPHILIC)CONTACT LENS...
K963488 · LPL
Specialty Ultravision, Inc.
Ophthalmic · 78d