FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Ophthalmic ×
5,110 results
1–24 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Aug 18, 2026
TearCare System
K262479 · ORZ
Sight Sciences, Inc.
Ophthalmic · 29d
Cleared Aug 13, 2026
MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution
K253795 · LPN
Menicon Co, Ltd.
Ophthalmic · 258d
Cleared Aug 10, 2026
Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A)
K253468 · MPA
Nova Eye, Inc.
Ophthalmic · 305d
Cleared Aug 04, 2026
OMNI Ultra Surgical System (1-110)
K253760 · MRH
Sight Sciences, Inc.
Ophthalmic · 252d
Cleared Jul 24, 2026
Temporary Keratoprosthesis (QuickSet TKP™)
K261312 · MLP
Eyekon Medical, Inc.
Ophthalmic · 94d
Cleared Jul 17, 2026
ZEISS CLINIC 360
K260694 · NFJ
Carl Zeiss Meditec, AG
Ophthalmic · 136d
Cleared Jul 07, 2026
HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens
K261812 · MVN
Hoya Lamphun , Ltd.
Ophthalmic · 36d
Cleared Jul 02, 2026
iPredict-DR
K253704 · PIB
iHealthscreen, Inc.
Ophthalmic · 220d
Cleared Jun 22, 2026
TearView
K253176 · HKI
Beyond 700 Pty, Ltd.
Ophthalmic · 269d
Cleared Jun 10, 2026
RxSight® Insertion Device
K261174 · MSS
Rxsight, Inc.
Ophthalmic · 62d
Cleared Jun 04, 2026
Harmony Referral System with Harmony OCT Viewer (Octave)
K253893 · NFJ
Topcon Healthcare Solutions EMEA Oy
Ophthalmic · 182d
Cleared May 29, 2026
Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens...
K260507 · LPL
INTEROJO, Inc.
Ophthalmic · 101d
Cleared May 21, 2026
Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses
K253352 · LPL
Pegavision Corporation
Ophthalmic · 233d
Cleared May 19, 2026
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses
K261299 · LPL
Pegavision Corporation
Ophthalmic · 29d
Cleared May 15, 2026
Stellaris Elite™ vision enhancement system
K261264 · HQC
Bausch and Lomb
Ophthalmic · 29d
Cleared 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 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 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