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
361–384 of 5,106
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
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 Aug 08, 2019
REFRESH RELIEVA For CONTACTS
K190674 · LPN
Allergan, Inc.
Ophthalmic · 146d
Cleared 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 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
Cleared Jun 25, 2019
CLARUS
K191194 · QER
Carl Zeiss Meditec, Inc.
Ophthalmic · 53d
Cleared Jun 21, 2019
MiiS Horus Scope DPT 100
K181260 · HKX
Medimaging Integrated Solution, Inc...
Ophthalmic · 406d
Cleared Jun 04, 2019
KOWA DR-1a
K190573 · HKI
Kowa Company , Ltd.
Ophthalmic · 90d
Cleared May 24, 2019
LightLas Pattern Scanning System - TruScan Pro
K190448 · HQF
Light-Med(Usa), Inc.
Ophthalmic · 88d
Cleared May 16, 2019
Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily...
K182734 · LPL
Unicon Optical Co., Ltd.
Ophthalmic · 230d
Cleared May 16, 2019
ARGOS
K191051 · MXK
Santec Corporation
Ophthalmic · 27d
Cleared May 03, 2019
Leaf Photocoagulator
K190083 · HQF
Norlase Aps
Ophthalmic · 106d
Cleared May 01, 2019
Vitreq disposable laser probes, light fibers and Chandelier
K182646 · HQB
Vitreq BV
Ophthalmic · 219d
Cleared Apr 29, 2019
MyDay
K190965 · LPL
CooperVision, Inc.
Ophthalmic · 17d
Cleared Apr 01, 2019
Microperimeter MP-3, Microperimeter MP-3 Type S
K190198 · HKI
Nidek Co., Ltd.
Ophthalmic · 56d
Cleared Mar 29, 2019
BL-Cart IOL Delivery Cartridge
K182965 · MSS
Ast Products, Inc.
Ophthalmic · 155d
Cleared Mar 26, 2019
WaveLight FS200 Patient Interface
K190392 · GEX
Alcon Laboratories, Inc.
Ophthalmic · 35d
Cleared Mar 06, 2019
VISULAS green
K181682 · HQF
Carl Zeiss Meditec, AG
Ophthalmic · 253d