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
193–216 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
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 CT 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 CT 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 CT Nov 10, 2022
AEYE-DS
K221183 · PIB
Aeye Health, Inc.
Ophthalmic · 199d
Cleared CT 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
Cleared Nov 03, 2022
Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes,...
K220263 · HQB
Vortex Surgical, Inc.
Ophthalmic · 276d
Cleared Nov 02, 2022
Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo
K222395 · HQF
Ellex Medical Pty, Ltd.
Ophthalmic · 86d
Cleared Oct 31, 2022
Excelsior
K220929 · NFJ
Merit Cro, Inc.
Ophthalmic · 214d
Cleared Oct 12, 2022
Aqua Naina Plus Sterile Saline Solution
K221263 · LPN
Chemtex USA, Inc.
Ophthalmic · 163d
Cleared Oct 11, 2022
ECHO Photocoagulator
K222157 · HQF
Norlase
Ophthalmic · 83d
Cleared Oct 06, 2022
iCare IC200
K220852 · HKY
Icare Finland OY
Ophthalmic · 197d
Cleared Oct 05, 2022
Cornisol
K221759 · LYX
Aurolab
Ophthalmic · 110d
Cleared Oct 04, 2022
POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR...
K221517 · LPL
INTEROJO, Inc.
Ophthalmic · 132d
Cleared CT Sep 29, 2022
CureSight-CS100
K221375 · QQU
Novasight , Ltd.
Ophthalmic · 140d
Cleared Sep 15, 2022
AIR OPTIX COLORS
K222500 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 28d
Cleared Sep 09, 2022
MICOR Lens Fragmentation System
K214028 · HQC
Carl Zeiss Meditec Cataract...
Ophthalmic · 261d