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
145–168 of 5,106
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Oct 11, 2023
Anterion
K230897 · OBO
Heidelberg Engineering GmbH
Ophthalmic · 194d
Cleared Sep 22, 2023
VISULAS yag
K230350 · HQF
Carl Zeiss Meditec, Inc.
Ophthalmic · 225d
Cleared Sep 19, 2023
Accuject Refra Injector AR2900
K231106 · MSS
Medicel AG
Ophthalmic · 153d
Cleared Sep 12, 2023
Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse
K231011 · HQF
Meridian AG
Ophthalmic · 155d
Cleared Sep 06, 2023
Phoenix ICON, Phoenix ICON GO
K223575 · HKI
Neolight, LLC
Ophthalmic · 280d
Cleared Sep 06, 2023
IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)
K230824 · LPL
Art Optical Contact Lens, Inc.
Ophthalmic · 166d
Cleared Sep 01, 2023
MS-39
K221601 · OBO
C.S.O. S.R.L.
Ophthalmic · 456d
Cleared Aug 30, 2023
Phoenix Contact Lens Case - dome top flat pack (CL-01)
K231123 · LRX
Phoenix Innovative Healthcare...
Ophthalmic · 132d
Cleared Aug 28, 2023
CALLISTO eye
K231676 · NFJ
Carl Zeiss Meditec, AG
Ophthalmic · 80d
Cleared Aug 25, 2023
OMNI Surgical System
K232214 · MRH
Sight Sciences, Inc.
Ophthalmic · 30d
Cleared Aug 18, 2023
P200TE (A10700)
K231673 · OBO
Optos Plc.
Ophthalmic · 71d
Cleared Aug 15, 2023
RxSight® Insertion Device (63002)
K231838 · MSS
Rxsight, Inc.
Ophthalmic · 54d
Cleared Jul 31, 2023
QUATERA 700
K230858 · HQC
Carl Zeiss Meditec, AG
Ophthalmic · 124d
Cleared Jul 31, 2023
Altris IMS
K232088 · NFJ
Altris, Inc.
Ophthalmic · 18d
Cleared Jun 29, 2023
MYAH
K222933 · MXK
Visia Imaging S.R.L.
Ophthalmic · 276d
Cleared Jun 16, 2023
EyeArt v2.2.0
K223357 · PIB
Eyenuk, Inc.
Ophthalmic · 226d
Cleared Jun 16, 2023
NewVision SC (tisilfocon A) Scleral Lens
K230910 · HQD
Acculens, Inc.
Ophthalmic · 77d
Cleared Jun 16, 2023
Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A)...
K230965 · HQD
Acuity Polymers, Inc.
Ophthalmic · 72d
Cleared Jun 12, 2023
RxSight Insertion Device
K231466 · MSS
Rxsight, Inc.
Ophthalmic · 24d
Cleared Jun 02, 2023
CorNeat EverPatch
K223074 · QWU
Corneat Vision , Ltd.
Ophthalmic · 245d
Cleared May 31, 2023
Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)
K222885 · LPL
Pegavision Corporation
Ophthalmic · 250d
Cleared May 12, 2023
Ahmed® Glaucoma Valve Model FP7
K230975 · KYF
New World Medical, Inc.
Ophthalmic · 37d
Cleared May 12, 2023
Ahmed® Glaucoma Valve Model FP8
K231051 · KYF
New World Medical, Inc.
Ophthalmic · 29d
Cleared May 09, 2023
Retitrack
K222484 · HLL
C. Light Technologies, Inc.
Ophthalmic · 265d