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
313–336 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Aug 11, 2020
LION Photocoagulator
K201623 · HQF
Norlase Aps
Ophthalmic · 57d
Cleared Aug 11, 2020
OMNI PLUS Surgical System
K201953 · MRH
Sight Sciences, Inc.
Ophthalmic · 28d
Cleared Aug 06, 2020
Vitra 810
K201502 · HQF
Quantel Medical
Ophthalmic · 62d
Cleared Aug 03, 2020
EyeArt
K200667 · PIB
Eyenuk, Inc.
Ophthalmic · 143d
Cleared Aug 03, 2020
Glaucoma Module
K200954 · NFJ
Topcon Healthcare Solutions, Inc.
Ophthalmic · 116d
Cleared Jul 31, 2020
xPORT 304 (miCOR) System Lens Fragmentation System
K200584 · HQC
Carl Zeiss Meditec Cataract...
Ophthalmic · 147d
Cleared Jul 31, 2020
VibrantVue Scleral Saline
K201069 · MRC
Dry Eye Innovations, LLC
Ophthalmic · 100d
Cleared Jul 23, 2020
Canon non-mydriatic retinal camera CR series
K201122 · HKI
Canon, Inc.
Ophthalmic · 87d
Cleared Jul 15, 2020
Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens,...
K201080 · LPL
Visco Vision, Inc.
Ophthalmic · 84d
Cleared Jul 14, 2020
Orbit Subretinal Delivery System
K200325 · FMF
Orbit Biomedical
Ophthalmic · 155d
Cleared Jun 17, 2020
Miru 1day UpSide (midafilcon A)
K193399 · LPL
Menicon Co, Ltd.
Ophthalmic · 194d
Cleared Jun 15, 2020
Visalis V500, Visalis S500
K193376 · HQC
Carl Zeiss Meditec, AG
Ophthalmic · 193d
Cleared Jun 04, 2020
bioli lOL Delivery System
K200057 · MSS
Ast Products, Inc.
Ophthalmic · 143d
Cleared Jun 02, 2020
Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A)...
K200528 · LPL
Bausch & Lomb, Incorporated
Ophthalmic · 92d
Cleared Jun 02, 2020
MIRA Adapter
K200911 · HRN
Phakos
Ophthalmic · 57d
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