FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Ophthalmic ×
5,106 results
337–360 of 5,106
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Mar 03, 2020
OVision Imaging System
K200275 · NFJ
Ophthalmic Labs, Inc.
Ophthalmic · 28d
Cleared Mar 02, 2020
Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution
K191872 · LPN
Menicon Co, Ltd.
Ophthalmic · 234d
Cleared Jan 22, 2020
Fundus Camera
K190954 · HKI
Chongqing Bio Newvision Medical...
Ophthalmic · 286d
Cleared Jan 17, 2020
RxSight Insertion Device
K192926 · MSS
Rxsight, Inc.
Ophthalmic · 93d
Cleared Jan 14, 2020
Icare ic200
K190316 · HKY
Icare Finland OY
Ophthalmic · 335d
Cleared Jan 14, 2020
MiiS Horus Eye Anterior Camera
K193188 · HJO
Medimaging Integrated Solution, Inc...
Ophthalmic · 57d
Cleared Dec 23, 2019
MAXReach Laser Probe
K191846 · HQB
Vortex Surgical, Inc.
Ophthalmic · 166d
Cleared Dec 19, 2019
Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q
K191314 · HKY
Chongqing Sunkingdom Medical...
Ophthalmic · 218d
Cleared Dec 09, 2019
Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear...
K192225 · LPL
Vizionfocus, Inc.
Ophthalmic · 115d
Cleared Dec 06, 2019
Intraocular Pressure Tonometer EASYTON
K190382 · HKX
Company Elamed
Ophthalmic · 290d
Cleared Dec 05, 2019
Vitra 2
K191962 · GEX
Quantel Medical
Ophthalmic · 135d
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 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