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AEYE-DS

by Aeye Health, Inc. 510(k)

Active United States

510(k) K221183

Overview

AEYE-DS is a diabetic retinopathy detection device. It is classified as a Class II medical device under regulation number 886.1100 and is intended for use in ophthalmic applications.

The device received FDA 510(k) clearance (K221183) as substantially equivalent through a traditional review process. It is manufactured by Aeye Health, Inc. and is authorized for marketing in the United States.

AI-generated from registry data, 28 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK221183 Date10 Nov 2022ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
PIB
Device Class
Class II
Regulation
21 CFR Part 886.1100
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Other devices from Aeye Health Inc.

Questions

  • What is the AEYE-DS device used for?

    The AEYE-DS is intended for diabetic retinopathy detection in ophthalmic applications, as specified in its FDA 510(k) clearance documentation.

  • How was the AEYE-DS cleared for marketing in the United States?

    The AEYE-DS received FDA 510(k) clearance (K221183) through a traditional review process, being found substantially equivalent to a predicate device.

  • What regulatory classification does the AEYE-DS have?

    The AEYE-DS is classified as a Class II medical device under regulation number 886.1100, as stated in its device specifications and clearance documentation.