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
1–24 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Oct 28, 2026
Saview 60 UV (Omafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens
K260311 · LPL
St. shine Optical Co., Ltd.
Ophthalmic · 271d
Cleared Oct 27, 2026
Adaptive Optics Scanning Laser Ophthalmoscope (Mona IV)
K261740 · MYC
Robotrak Technologies Co., Ltd.
Ophthalmic · 153d
Cleared Oct 23, 2026
OxyPure (olifilcon A) Spherical Biweekly Silicone Hydrogel Soft Contact Lens
K253875 · LPL
Visco Vision, Inc.
Ophthalmic · 323d
Cleared Oct 16, 2026
Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft...
K262941 · LPL
Bausch & Lomb, Inc.
Ophthalmic · 56d
Cleared Oct 15, 2026
MICOR 700 System (N/A)
K262097 · HQC
Carl Zeiss Meditec Cataract Technologies
Ophthalmic · 115d
Cleared Sep 18, 2026
SLIT LAMP SL-D4 (Type: LED)
K262637 · HJO
Topcon Corporation
Ophthalmic · 51d
Cleared Sep 17, 2026
Miru 1day UpSide (midafilcon A)
K262495 · LPL
Menicon Co, Ltd.
Ophthalmic · 59d
Cleared Sep 11, 2026
KOWA FM-600
K261255 · MYC
Kowa Company, Ltd. Chofu Factory
Ophthalmic · 148d
Cleared CT Sep 11, 2026
ANTERION
K261019 · OBO
Heidelberg Engineering GmbH
Ophthalmic · 168d
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