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
337–360 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jun 01, 2020
XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System
K193319 · HKI
Vasoptic Medical, Inc.
Ophthalmic · 182d
Cleared May 27, 2020
Phacoemulsification Needle (Tip) and Irrigation Sleeve
K192418 · HQC
Raico, LLC
Ophthalmic · 266d
Cleared May 26, 2020
Aqua Naina Sterile Saline Solution
K193441 · LPN
Chemtex USA, Inc.
Ophthalmic · 167d
Cleared May 21, 2020
Systane iLux2
K200400 · ORZ
Tear Film Innovations, Inc.
Ophthalmic · 93d
Cleared May 18, 2020
Catalys Precision Laser System
K200056 · OOE
Amo Manufacturng USA, LLC
Ophthalmic · 126d
Cleared May 15, 2020
PuriLens Plus Preservative Free Saline
K200747 · LPN
The Lifestyle Company, Inc.
Ophthalmic · 53d
Cleared May 07, 2020
Icare HOME Tonometer
K200966 · HKY
Icare Finland OY
Ophthalmic · 27d
Not Cleared May 01, 2020
iTEAR Neurostimulator
DEN190026 · QKV
Olympic Ophthalmics, Inc.
Ophthalmic · 352d
Cleared Apr 27, 2020
Mydriatic Hyperspectral Retinal Camera (MHRC-C1)
K200254 · HKI
Optina Diagnostics
Ophthalmic · 84d
Cleared Mar 26, 2020
Konan Specular Microscope XVII
K191558 · NQE
Konan Medical, Inc.
Ophthalmic · 288d
Cleared Mar 23, 2020
MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon...
K191763 · LPL
CooperVision, Inc.
Ophthalmic · 266d
Cleared Mar 17, 2020
ACUVUE (senofilcon A) Soft Contact Lens Multifocal
K200243 · LPL
Johnson & Johnson Vision Care, Inc.
Ophthalmic · 46d
Cleared Mar 16, 2020
CONTINUUM PACS
K200385 · NFJ
Integrated Ophthalmic Systems, Inc.
Ophthalmic · 27d
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