EyeArt v2.2.0

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K223357

Identifiers

510(k) Number: K223357 FDA 510(k)
FDA Product Code: PIB FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 886.1100 FDA 510(k)
Regulation Number: 886.1100 FDA 510(k)
Advisory Committee: Ophthalmic FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

EyeArt v2.2.0 is a Diabetic Retinopathy Detection Device, classified under 21 CFR 886.1100 as a Class II medical device. It employs artificial intelligence to automatically analyze retinal images and identify signs of diabetic retinopathy in adult patients, supporting early detection of vision-threatening conditions.

This software-based device is intended for use in ophthalmic settings and operates as a non-invasive, autonomous diagnostic tool. Supplied as a digital platform, it requires compatible imaging equipment for retinal image capture and is not intended for direct patient contact. The device holds FDA 510(k) clearance (K223357) and complies with the Medical Device Directive (MDD), ensuring regulatory adherence for clinical deployment.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: AI-Powered Eye Screening & Diagnostic Solutions | Eyenuk, Eyenuk | FDA-Cleared Autonomous AI Screening for Diabetic Retinopathy, EyeArt: AI-based Diabetic Retinopathy Detection software, EyeArt v2.2.0 (K223357) — FDA 510 (k) | Innolitics

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K223357	Class II	Active

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Manufacturer

Manufacturer: Eyenuk, Inc.

Sources (2)

FDA 510(k) K223357 24 fields · synced Sep 18, 2026
EUDAMED 1 fields · synced May 19, 2026