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
361–384 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Nov 15, 2019
Ophthalmic Yag Laser System YC-200
K192045 · HQF
Nidek Co., Ltd.
Ophthalmic · 107d
Cleared Nov 15, 2019
DRSplus
K192113 · MYC
Centervue S.P.A.
Ophthalmic · 102d
Cleared Nov 01, 2019
LEGION System
K191650 · HQC
Alcon Research, LLC
Ophthalmic · 134d
Cleared Oct 24, 2019
Tear Pool Dissolvable Punctum Plugs
K190210 · LZU
Alphamed, Inc.
Ophthalmic · 262d
Cleared Oct 22, 2019
LipiFlow Thermal Pulsation System
K192623 · ORZ
Tearscience, Inc.
Ophthalmic · 29d
Cleared Oct 04, 2019
Bausch + Lomb PreVue Inserter for enVista Preloaded
K192005 · MSS
Bausch & Lomb, Inc.
Ophthalmic · 67d
Cleared CT Oct 02, 2019
OxySoft (olifilcon C) silicone hydrogel soft contact lens
K191397 · LPL
Visco Vision, Inc.
Ophthalmic · 131d
Cleared Sep 27, 2019
ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact...
K192129 · LPL
Clearlab SG Pte, Ltd.
Ophthalmic · 51d
Cleared Sep 26, 2019
Spectralis HRA+OCT and Variants
K192391 · OBO
Heidelberg Engineering GmbH
Ophthalmic · 23d
Cleared Sep 25, 2019
EVA, anterior machine, EVA, combined machine, EVA combined machine with laser...
K190875 · HQC
D.O.R.C. Dutch Ophthalmic Research...
Ophthalmic · 174d
Cleared Sep 17, 2019
UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens
K191929 · LPL
Unicon Optical Co., Ltd.
Ophthalmic · 60d
Cleared Sep 13, 2019
Vexillum Zephyr (olifilcon A) with Tangible Polymers...
K183670 · LPL
Visco Vision, Inc.
Ophthalmic · 260d
Cleared Sep 13, 2019
UNFOLDER Vitan Inserter
K191949 · MSS
Johnson & Johnson Surgical Vision, Inc.
Ophthalmic · 53d
Cleared Sep 10, 2019
KOWA nonmyd 8
K191945 · HKI
Kowa Company , Ltd.
Ophthalmic · 50d
Cleared Sep 06, 2019
Apioc (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc...
K191121 · LPL
Lentechs, LLC
Ophthalmic · 133d
Cleared Aug 16, 2019
COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT...
K191933 · HQC
Johnson & Johnson Surgical Vision, Inc.
Ophthalmic · 28d
Cleared Aug 13, 2019
xPORT Lens Fragmentation System
K191024 · HQC
Carl Zeiss Meditec Cataract...
Ophthalmic · 117d
Cleared CT Aug 08, 2019
REFRESH RELIEVA For CONTACTS
K190674 · LPN
Allergan, Inc.
Ophthalmic · 146d
Cleared CT Jul 31, 2019
P200TxE
K190732 · OBO
Optos Plc.
Ophthalmic · 132d
Cleared Jul 31, 2019
AOCup Lens Case with AODisc
K191795 · LPN
Alcon Laboratories, Inc.
Ophthalmic · 28d
Cleared Jul 25, 2019
Galilei G6 Lens Professional
K182659 · MXK
Sis Ag, Surgical Instrument Systems
Ophthalmic · 303d
Cleared CT Jul 24, 2019
Canon OCT-A1
K182942 · OBO
Canon, Inc.
Ophthalmic · 274d
Cleared Jul 24, 2019
MaxiTears Contacts PF
K182984 · MRC
Omnivision AG
Ophthalmic · 268d
Cleared Jul 18, 2019
Huvitz Imaging System
K191615 · NFJ
Huvitz Co., Ltd.
Ophthalmic · 30d