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
121–144 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared May 15, 2024
CANON Fundus Camera CR-10 (CR-10)
K241049 · HKI
Canon, Inc.
Ophthalmic · 28d
Not Cleared May 15, 2024
Notal Vision Home Optical Coherence Tomography (OCT) System
DEN230043 · SAX
Notal Vision, Inc.
Ophthalmic · 343d
Cleared CT May 09, 2024
P200TE (A10700)
K233602 · OBO
Optos Plc.
Ophthalmic · 182d
Cleared May 08, 2024
Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses
K232649 · LPL
Pegavision Corporation
Ophthalmic · 251d
Cleared May 01, 2024
Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)
K233516 · HKY
Reichert, Inc.
Ophthalmic · 182d
Cleared CT Apr 23, 2024
AEYE-DS
K240058 · PIB
Aeye Health, Inc.
Ophthalmic · 106d
Cleared Apr 17, 2024
Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft...
K240519 · LPL
Innova Vision, Inc.
Ophthalmic · 54d
Cleared Apr 10, 2024
3D Optical Coherence Tomography (3D OCT-1(type: Maestro2))
K233561 · OBO
Topcon Corporation
Ophthalmic · 156d
Cleared Apr 03, 2024
Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
K240618 · HQD
Acuity Polymers, Inc.
Ophthalmic · 29d
Cleared Mar 08, 2024
RESCAN 700
K233421 · OBO
Carl Zeiss Meditec, AG
Ophthalmic · 150d
Cleared Mar 08, 2024
HP-OCT (HP-OCT)
K231760 · HJO
Cylite Pty. , Ltd.
Ophthalmic · 266d
Cleared Mar 01, 2024
IMAGEnet6 Ophthalmic Data System
K232828 · NFJ
Topcon Corporation
Ophthalmic · 170d
Cleared Feb 26, 2024
Stellaris Elite vision enhancement system
K232084 · HQC
Bausch and Lomb
Ophthalmic · 228d
Cleared Feb 21, 2024
Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon...
K233325 · HQD
Visionary Optics, LLC
Ophthalmic · 145d
Cleared Feb 09, 2024
CATS-L Tonometer™ Prism
K234037 · HKY
Cats Tonometer, LLC
Ophthalmic · 50d
Cleared Feb 06, 2024
Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)
K233221 · LPL
Metro Optics of Austin, Inc.
Ophthalmic · 131d
Cleared Jan 25, 2024
Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable...
K234127 · LPL
CooperVision, Inc.
Ophthalmic · 28d
Cleared Jan 25, 2024
MR Q
K232417 · HQF
Meridian AG
Ophthalmic · 167d
Cleared Jan 10, 2024
Centurion™ Vision System (Active Sentry™) (8065753057)
K233902 · HQC
Alcon Laboratories, Inc.
Ophthalmic · 30d
Cleared CT Jan 03, 2024
HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA...
K223397 · LPL
Hoya Lamphun , Ltd.
Ophthalmic · 421d
Cleared Dec 29, 2023
Precision1
K233856 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 24d
Cleared Dec 27, 2023
TearCare MGX System
K231084 · ORZ
Sight Sciences, Inc.
Ophthalmic · 254d
Cleared Dec 21, 2023
CALLISTO eye
K232944 · NFJ
Carl Zeiss Meditec, AG
Ophthalmic · 92d
Cleared Dec 20, 2023
Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens...
K223585 · LPL
Yung Sheng Optical Co., Ltd.
Ophthalmic · 384d