FDA 510(k)

EyeArt v2.2.0

K-Number: K223357 · 2023-06-16

Decision Date2023-06-16

Product CodePIB

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

EyeArt v2.2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Eyenuk, Inc.. It received FDA 510(k) clearance on 2023-06-16 under 510(k) number K223357. The device is classified under product code PIB. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EyeArt v2.2.0?

EyeArt v2.2.0 is a medical device that received FDA 510(k) clearance on 2023-06-16. The listed applicant is Eyenuk, Inc.. The 510(k) number is K223357.

When did EyeArt v2.2.0 receive FDA 510(k) clearance?

EyeArt v2.2.0 received FDA 510(k) clearance on 2023-06-16, under 510(k) number K223357.

Who is the listed applicant for EyeArt v2.2.0?

The FDA 510(k) record lists Eyenuk, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EyeArt v2.2.0?

The FDA product code for EyeArt v2.2.0 is PIB.

Other records listing Eyenuk, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K200667EyeArt

Related Devices (Code: PIB)

K253704iPredict-DRiHealthscreen, Inc.K240058AEYE-DSAeye Health, Inc.K221183AEYE-DSAeye Health, Inc.K213037IDx-DR v2.3Digital Diagnostics, Inc.K203629IDx-DRDigital Diagnostics, Inc.K200667EyeArtEyenuk, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.