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
25–48 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared CT May 07, 2026
SPECTRALIS HRA+OCT and variants
K253837 · OBO
Heidelberg Engineering GmbH
Ophthalmic · 157d
Cleared Apr 30, 2026
FSYX Ocular Pressure Adjusting Pump
K252455 · QQJ
Balance Ophthalmics, Inc.
Ophthalmic · 268d
Cleared Apr 29, 2026
PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS
K253885 · LPL
GEO MEDICAL CO., LTD.
Ophthalmic · 146d
Cleared CT Apr 27, 2026
TearCare MGX System
K252409 · ORZ
Sight Sciences, Inc.
Ophthalmic · 269d
Cleared Apr 07, 2026
Voyager DSLT (430840610)
K252979 · HQF
Belkin Vision, Ltd.
Ophthalmic · 202d
Cleared CT Apr 01, 2026
RM Electrode (RMH 25-01)
K253586 · HLZ
Retmap, Inc.
Ophthalmic · 135d
Cleared Mar 27, 2026
GPA (hexafocon A) Rigid Gas Permeable Contact Lenses
K253822 · HQD
Zhuhai Fitlens Medical Technology...
Ophthalmic · 119d
Cleared Mar 25, 2026
Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455,...
K252052 · HQC
Bausch and Lomb, Incorporated
Ophthalmic · 267d
Cleared Mar 19, 2026
Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic)...
K254269 · LPL
St. shine Optical Co., Ltd.
Ophthalmic · 79d
Cleared Mar 18, 2026
VISUREF 600
K253834 · HJO
Carl Zeiss Vision GmbH
Ophthalmic · 107d
Cleared Mar 13, 2026
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses
K252385 · LPL
Pegavision Corporation
Ophthalmic · 225d
Cleared Mar 13, 2026
Pentacam® Cornea OCT
K251848 · MXK
Oculus Optikger?te GmbH
Ophthalmic · 270d
Cleared Feb 13, 2026
DAILIES TOTAL1®
K254052 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 58d
Cleared Feb 10, 2026
LANDR Contact LENS Case
K252175 · LRX
Fourth Axis, LLC
Ophthalmic · 214d
Cleared Feb 06, 2026
INTEGRE LIO
K251507 · HQF
Quantel Medical
Ophthalmic · 266d
Cleared Jan 16, 2026
Eyer 2
K251353 · HKI
Phelcom Technologies
Ophthalmic · 261d
Cleared CT Dec 23, 2025
UNITY DX (UDX)
K252633 · OBO
Cylite Pty. , Ltd.
Ophthalmic · 125d
Cleared Dec 23, 2025
Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV...
K251683 · LPL
Bruno Vision Care, LLC
Ophthalmic · 207d
Cleared Dec 18, 2025
Tomey Optical Biometer OA-2000 (OA-2000)
K252348 · MXK
Tomey Corporation
Ophthalmic · 142d
Cleared Dec 12, 2025
Fundus On Phone Non Mydriatic (FOP NM-10)
K252120 · HKI
Remidio Innovative Solutions Private...
Ophthalmic · 158d
Cleared Nov 14, 2025
System Sophi
K250501 · HQC
This AG
Ophthalmic · 267d
Cleared Nov 07, 2025
AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA
K253039 · HKX
Topcon Corporation
Ophthalmic · 46d
Cleared Oct 29, 2025
Navilas Laser System 577sl (156691)
K251772 · HQF
Od-Os GmbH
Ophthalmic · 141d
Cleared CT Oct 09, 2025
cleadew GP hydra one
K251876 · MRC
Ophtecs Corporation
Ophthalmic · 113d