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
169–192 of 5,106
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared May 05, 2023
Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses
K221768 · HQD
Paragon Vision Sciences, Inc.
Ophthalmic · 322d
Cleared 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 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
Cleared Feb 23, 2023
Iridex 532 Laser
K230228 · HQF
Iridex Corporation
Ophthalmic · 27d
Cleared Feb 22, 2023
Eyer Retinal Camera NM-STD
K221329 · HKI
Phelcom Technologies
Ophthalmic · 292d
Cleared Dec 27, 2022
R:GEN
K220974 · HQF
Lutronic Vision, Inc.
Ophthalmic · 267d
Cleared Dec 23, 2022
Visant Medical Canalicular Plug
K222164 · LZU
Visant Medical, Inc.
Ophthalmic · 155d
Cleared Dec 07, 2022
Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon...
K223394 · HQD
Visionary Optics, LLC
Ophthalmic · 29d
Cleared Dec 06, 2022
Bausch + Lomb Preservative Free Lubricating and Rewetting Drops
K222541 · LPN
Bausch & Lomb, Incorporated
Ophthalmic · 106d
Cleared Nov 22, 2022
E3 and Profile
K221471 · GWE
Diagnosys, LLC
Ophthalmic · 186d
Cleared Nov 21, 2022
Vision Monitor- MonCvONE
K212936 · GWE
Metrovision
Ophthalmic · 432d
Cleared Nov 21, 2022
Kowa SL-19
K222372 · HJO
Kowa Company , Ltd.
Ophthalmic · 108d
Cleared Nov 10, 2022
AEYE-DS
K221183 · PIB
Aeye Health, Inc.
Ophthalmic · 199d
Cleared Nov 09, 2022
SOLIX
K222166 · OBO
Optovue, Inc.
Ophthalmic · 111d
Cleared Nov 09, 2022
Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)
K223132 · HQF
Iridex Corporation
Ophthalmic · 37d
Cleared Nov 04, 2022
Luminopia One
K221659 · QQU
Luminopia, Inc.
Ophthalmic · 149d