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
385–408 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
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
Cleared Mar 05, 2019
ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color)
K181656 · LPL
Eyemed Technologies S.R.L.
Ophthalmic · 256d
Cleared Feb 15, 2019
CIRRUS HD-OCT
K181534 · OBO
Carl Zeiss Meditec, Inc.
Ophthalmic · 249d
Cleared Feb 12, 2019
Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens
K183167 · HQD
Bausch & Lomb, Incorporated
Ophthalmic · 89d
Cleared Feb 12, 2019
KOWA VK-2s
K190056 · NFJ
Kowa Co. Ltd. Chofu
Ophthalmic · 32d
Cleared Feb 08, 2019
Keeler TonoCare Tonometer
K181143 · HKX
Keeler Instruments, Inc.
Ophthalmic · 283d
Cleared Feb 06, 2019
DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives
K190045 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 28d
Cleared Jan 30, 2019
Boston Keratoprosthesis, Type I Lucia
K182986 · HQM
Massachusetts Eye and Ear Infirmary...
Ophthalmic · 93d
Cleared Jan 18, 2019
AHMED ClearPath Glaucoma Drainage Device
K182518 · KYF
New World Medical, Inc.
Ophthalmic · 127d
Cleared Jan 18, 2019
DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM,...
K182782 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 109d
Cleared Jan 11, 2019
RESCAN 700, CALLISTO eye
K180229 · OBO
Carl Zeiss Meditec, AG
Ophthalmic · 350d
Cleared Jan 10, 2019
CLARUS
K181444 · QER
Carl Zeiss Meditec, Inc.
Ophthalmic · 223d