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
145–168 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Dec 08, 2023
Eagle device
K230722 · HQF
Belkin Vision, Ltd.
Ophthalmic · 267d
Cleared CT Dec 07, 2023
RM Electrode (RMH 23-01)
K232273 · HLZ
Retmap, Inc.
Ophthalmic · 129d
Cleared Dec 05, 2023
Optina-4C (MHRC-C1N)
K231230 · HKI
Optina Diagnostics, Inc.
Ophthalmic · 221d
Cleared Nov 20, 2023
Zilia Ocular FC (ZIL-10002)
K230627 · HKI
Zilia, Inc.
Ophthalmic · 259d
Cleared Nov 20, 2023
Harmony
K232555 · NFJ
Topcon Healthcare Solutions
Ophthalmic · 89d
Cleared CT Nov 17, 2023
Samfilcon B Custom Contact Lens
K230954 · LPL
Bausch & Lomb, Incorporated
Ophthalmic · 227d
Cleared CT Nov 16, 2023
Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens
K232139 · LPL
Innova Vision, Inc.
Ophthalmic · 121d
Cleared Nov 16, 2023
DAILIES TOTAL1®
K232921 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 58d
Cleared Nov 08, 2023
VS Tabletop Tonometer
K223739 · HKX
Medimaging Integrated Solution, Inc.
Ophthalmic · 329d
Cleared Oct 30, 2023
3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)
K231222 · OBO
Topcon Corporation
Ophthalmic · 185d
Cleared Oct 24, 2023
VISULAS green
K232051 · HQF
Carl Zeiss Meditec
Ophthalmic · 106d
Cleared Oct 23, 2023
Applanation Tonometer HT-5000
K232143 · HKY
Huvitz Co., Ltd.
Ophthalmic · 96d
Cleared Oct 20, 2023
SPECTRALIS HRA+OCT and variants
K223557 · OBO
Heidelberg Engineering GmbH
Ophthalmic · 329d
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 CT Aug 18, 2023
P200TE (A10700)
K231673 · OBO
Optos Plc.
Ophthalmic · 71d