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
265–288 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared CT Nov 05, 2021
Anterion
K211817 · OBO
Heidelberg Engineering GmbH
Ophthalmic · 147d
Cleared Oct 26, 2021
Avaira Vitality
K213164 · LPL
CooperVision, Inc.
Ophthalmic · 28d
Not Cleared Oct 20, 2021
Luminopia One
DEN210005 · QQU
Luminopia, Inc.
Ophthalmic · 233d
Cleared Oct 08, 2021
Streamline Surgical System
K211680 · MRH
New World Medical, Inc.
Ophthalmic · 129d
Cleared Sep 13, 2021
Harmony Referral System
K210396 · NFJ
Topcon Healthcare Solutions EMEA Oy
Ophthalmic · 215d
Cleared Aug 23, 2021
CLAREON MONARCH IV IOL Delivery System
K212039 · MSS
Alcon Laboratories, Inc.
Ophthalmic · 54d
Cleared Aug 20, 2021
Nam illumination probe with chopper
K202670 · MPA
Oculight , Ltd.
Ophthalmic · 340d
Cleared Aug 19, 2021
EIDON FA, EIDON, EIDON AF, EIDON UWFL
K211328 · MYC
Centervue S.P.A.
Ophthalmic · 108d
Cleared Jul 26, 2021
Vision Monitor - MonpackONE
K211643 · GWE
Metrovision
Ophthalmic · 60d
Cleared Jul 14, 2021
Myopia Master
K202989 · MXK
Oculus Optikger?te GmbH
Ophthalmic · 287d
Cleared Jun 15, 2021
CellChek 20 rc
K203244 · NFJ
Konan Medical, Inc.
Ophthalmic · 224d
Cleared Jun 14, 2021
CATS®-D Tonometer Prism
K203850 · HKY
Cats Tonometer, LLC
Ophthalmic · 165d
Cleared Jun 11, 2021
Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants
K203569 · NCB
Fci (France Chirurgie...
Ophthalmic · 186d
Cleared Jun 10, 2021
IDx-DR
K203629 · PIB
Digital Diagnostics, Inc.
Ophthalmic · 181d
Cleared CT May 28, 2021
ABT12 multi-purpose solution
K202932 · LPN
Bausch & Lomb, Incorporated
Ophthalmic · 241d
Cleared CT May 26, 2021
OTE MPS 045 Multi-purpose Lens Care Solution
K210051 · LPN
Ote North America, LLC
Ophthalmic · 138d
Cleared May 24, 2021
Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia
K210975 · LPL
Bausch & Lomb, Incorporated
Ophthalmic · 53d
Cleared May 11, 2021
Valley Contax Single Vision (SV) Gas Permeable Contact Lens (roflufocon D,...
K202860 · HQD
Valley Contax, Inc.
Ophthalmic · 225d
Cleared Apr 27, 2021
AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens
K210609 · LPL
Vp Optics
Ophthalmic · 57d
Cleared Apr 26, 2021
MicroDose Injector
K203264 · FMF
Medone Surgical, Inc.
Ophthalmic · 172d
Cleared Apr 13, 2021
RetCam Envision
K203500 · HKI
Natus Medical Incorporated Dba...
Ophthalmic · 134d
Cleared Apr 13, 2021
NFC-600 Automated Portable Retinal Camera
K210197 · HKI
Crystalvue Medical Corporation
Ophthalmic · 78d
Cleared Apr 12, 2021
Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal...
K210436 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 59d
Cleared Apr 09, 2021
Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
K203571 · HQD
Acuity Polymers, Inc.
Ophthalmic · 123d