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
169–192 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Aug 15, 2023
RxSight® Insertion Device (63002)
K231838 · MSS
Rxsight, Inc.
Ophthalmic · 54d
Cleared Jul 31, 2023
QUATERA 700
K230858 · HQC
Carl Zeiss Meditec, AG
Ophthalmic · 124d
Cleared Jul 31, 2023
Altris IMS
K232088 · NFJ
Altris, Inc.
Ophthalmic · 18d
Cleared Jun 29, 2023
MYAH
K222933 · MXK
Visia Imaging S.R.L.
Ophthalmic · 276d
Cleared CT Jun 16, 2023
EyeArt v2.2.0
K223357 · PIB
Eyenuk, Inc.
Ophthalmic · 226d
Cleared Jun 16, 2023
NewVision SC (tisilfocon A) Scleral Lens
K230910 · HQD
Acculens, Inc.
Ophthalmic · 77d
Cleared Jun 16, 2023
Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A)...
K230965 · HQD
Acuity Polymers, Inc.
Ophthalmic · 72d
Cleared Jun 12, 2023
RxSight Insertion Device
K231466 · MSS
Rxsight, Inc.
Ophthalmic · 24d
Cleared Jun 02, 2023
CorNeat EverPatch
K223074 · QWU
Corneat Vision , Ltd.
Ophthalmic · 245d
Cleared May 31, 2023
Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)
K222885 · LPL
Pegavision Corporation
Ophthalmic · 250d
Cleared May 12, 2023
Ahmed® Glaucoma Valve Model FP7
K230975 · KYF
New World Medical, Inc.
Ophthalmic · 37d
Cleared May 12, 2023
Ahmed® Glaucoma Valve Model FP8
K231051 · KYF
New World Medical, Inc.
Ophthalmic · 29d
Cleared CT May 09, 2023
Retitrack
K222484 · HLL
C. Light Technologies, Inc.
Ophthalmic · 265d
Cleared May 05, 2023
Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses
K221768 · HQD
Paragon Vision Sciences, Inc.
Ophthalmic · 322d
Cleared CT Apr 20, 2023
Precision1, Precision1 for Astigmatism
K230785 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 29d
Cleared Apr 14, 2023
ELITA™ Femtosecond Laser System, ELITA™ Patient Interface
K223566 · OOE
Johnson & Johnson Surgical Vision, Inc.
Ophthalmic · 136d
Cleared Apr 13, 2023
CIRRUS HD-OCT
K222200 · OBO
Carl Zeiss Meditec, Inc.
Ophthalmic · 262d
Cleared Apr 12, 2023
Catalys™ Precision Laser System
K223838 · OOE
Amo Manufacturing USA, LLC
Ophthalmic · 111d
Cleared Apr 11, 2023
ZeptoLink IOL Positioning System
K223763 · PUL
Centricity Vision, Inc.
Ophthalmic · 117d
Cleared CT Mar 30, 2023
Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing...
K221320 · OBO
Nidek Co., Ltd.
Ophthalmic · 328d
Cleared Mar 30, 2023
ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System
K221872 · MPA
Nova Eye Inc. (Business Name Nova Eye...
Ophthalmic · 275d
Cleared Mar 15, 2023
iExaminer System with Panoptic Plus
K223381 · HKI
Welch Allyn, Inc.
Ophthalmic · 128d
Cleared Mar 13, 2023
Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens
K222954 · LPL
Innova Vision, Inc.
Ophthalmic · 167d
Cleared Mar 08, 2023
Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb...
K220613 · LPL
Bausch & Lomb, Incorporated
Ophthalmic · 370d