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
217–240 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Sep 08, 2022
BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens
K220143 · LPL
Shenzhen Dashicheng Optical...
Ophthalmic · 233d
Cleared CT Sep 07, 2022
EyeCTester
K203594 · QTW
Neuro-Eye Diagnostic Systems, LLC
Ophthalmic · 637d
Cleared Sep 02, 2022
Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for...
K213983 · LPL
Yung Sheng Optical Co., Ltd.
Ophthalmic · 256d
Cleared Aug 29, 2022
Non-Mydriatic Retinal Camera NW500
K221111 · HKI
Topcon Corporation
Ophthalmic · 136d
Cleared Aug 24, 2022
miCOR System Lens Fragmentation System
K222236 · HQC
Carl Zeiss Meditec Cataract...
Ophthalmic · 29d
Cleared Aug 15, 2022
FORUM
K213527 · NFJ
Carl Zeiss Meditec, AG
Ophthalmic · 284d
Cleared CT Aug 12, 2022
Visibly Digital Acuity Product
K220090 · QTO
Visibly, Inc.
Ophthalmic · 213d
Cleared Aug 10, 2022
UniVit HE, UniVit UHS
K212763 · HQE
Visioncare Devices, LLC
Ophthalmic · 344d
Cleared Aug 05, 2022
TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)
K220045 · LPL
Dk Medivision Co., Ltd.
Ophthalmic · 212d
Cleared CT Aug 02, 2022
iStent infinite Trabecular Micro-Bypass System, Model iS3
K220032 · KYF
Glaukos Corporation
Ophthalmic · 209d
Cleared Jul 15, 2022
Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems
K220877 · HQF
Lumenis Be, Inc.
Ophthalmic · 112d
Cleared Jun 24, 2022
EZYPOR
K212741 · HPZ
Fci (France Chirurgie...
Ophthalmic · 298d
Cleared Jun 23, 2022
ZEPTO Precision Capsulotomy System
K221188 · PUL
Centricity Vision, Inc.
Ophthalmic · 59d
Cleared Jun 17, 2022
IDx-DR v2.3
K213037 · PIB
Digital Diagnostics, Inc.
Ophthalmic · 269d
Cleared Jun 14, 2022
EVA NEXUS Ophthalmic Surgical System
K213467 · HQC
D.O.R.C. Dutch Ophthalmic Research...
Ophthalmic · 229d
Cleared Jun 09, 2022
ALLY Adaptive Cataract Treatment System
K220259 · OOE
Lensar, Inc.
Ophthalmic · 129d
Cleared Jun 08, 2022
TrabEx Pro
K213173 · MRH
Microsurgical Technologies, Inc.
Ophthalmic · 253d
Cleared Jun 03, 2022
SOFT PLUG Extended Duration 180 Tapered Canalicular Plug
K213988 · LZU
Oasis Medical, Inc.
Ophthalmic · 165d
Cleared May 17, 2022
CATALYS Precision Laser system
K220516 · OOE
Amo Manufacturing USA, LLC
Ophthalmic · 83d
Cleared May 13, 2022
Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens
K213119 · LPL
Innova Vision, Inc.
Ophthalmic · 228d
Cleared May 12, 2022
Capsulo
K220430 · HQF
Quantel Medical
Ophthalmic · 86d
Cleared May 04, 2022
Vista Ophthalmics Vitrectomy Probe
K220030 · MLZ
Vista Ophthalmics, LLC
Ophthalmic · 119d
Not Cleared May 02, 2022
Kerasave
DEN200063 · QCW
Al.Chi.Mi.A. S.R.L
Ophthalmic · 578d
Cleared Apr 28, 2022
RetinAI Discovery
K211715 · NFJ
Retinai Medical AG
Ophthalmic · 329d