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
385–408 of 5,106
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
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
Cleared Jan 09, 2019
iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses
K183200 · MUW
C&E GP Specialist, Inc.
Ophthalmic · 51d
Cleared Jan 04, 2019
BostonSight Scleral
K183175 · HQD
Bostonsight
Ophthalmic · 49d
Cleared Jan 02, 2019
NFC-700 non-mydriatic auto fundus camera
K182199 · HKI
Crystalvue Medical Corporation
Ophthalmic · 141d
Cleared Dec 21, 2018
LENSAR Laser System - fs 3D (LLS-fs 3D)
K182795 · OOE
Lensar, Inc.
Ophthalmic · 81d
Cleared Dec 21, 2018
3nethra neo
K183059 · HKI
Forus Health Pvt.Ltd
Ophthalmic · 49d
Cleared Dec 14, 2018
Tono Vue Non-Contact Tonometer
K180820 · HKX
Crystalvue Medical Corporation
Ophthalmic · 260d
Cleared Dec 11, 2018
Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens...
K181920 · LPL
CooperVision, Inc.
Ophthalmic · 146d
Cleared Dec 11, 2018
Precision1
K182902 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 56d
Cleared Dec 10, 2018
Applanation tonometer AT-2
K182491 · HKY
Takagi Seiko Co., Ltd.
Ophthalmic · 90d
Cleared Dec 10, 2018
LipiScan Dynamic Meibomian Imager
K182506 · HKI
Tearscience, Inc.
Ophthalmic · 89d
Cleared Nov 30, 2018
Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens
K182249 · LPL
Bausch & Lomb, Incorporated
Ophthalmic · 102d
Cleared Nov 23, 2018
Hyper GP (tisilfocon A) Daily Wear Contact Lens
K182304 · HQD
Contamac, Ltd.
Ophthalmic · 91d
Cleared Nov 22, 2018
Sunkingdom Slit Lamp
K182306 · HJO
Chongqing Sunkingdom Medical...
Ophthalmic · 90d