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FDA 510(k)

EyeArt v2.2.0

K-Number: K223357 · 2023-06-16

ApplicantEyenuk, Inc.
Decision Date2023-06-16
Product CodePIB
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

EyeArt v2.2.0 is a medical device manufactured by Eyenuk, Inc.. It received FDA 510(k) clearance on 2023-06-16 under approval 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. It is manufactured by Eyenuk, Inc.. The 510(k) number is K223357.

When was EyeArt v2.2.0 approved by the FDA?

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

What company makes EyeArt v2.2.0?

EyeArt v2.2.0 is manufactured by Eyenuk, Inc..

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

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

Other Devices by Eyenuk, Inc.

K200667EyeArt

Related Devices (Code: PIB)

DEN180001IDx-DRIdx, LLC K200667EyeArtEyenuk, Inc. K203629IDx-DRDigital Diagnostics, Inc. K221183AEYE-DSAeye Health, Inc. K213037IDx-DR v2.3Digital Diagnostics, Inc. K240058AEYE-DSAeye Health, 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.

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