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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diabetic Retinopathy Detection Device
510(k) Number K240058
Device Name AEYE-DS
Applicant
AEYE Health Inc.
200 Park Ave (17th Floor)
New York,  NY  10166
Applicant Contact Zack Dvey-Aharon
Correspondent
A. Stein - Regulatory Affairs Consulting Ltd.
18 Hata'as Str.
Kfar Saba,  IL 4442518
Correspondent Contact Ahava Stein
Regulation Number886.1100
Classification Product Code
PIB  
Date Received01/08/2024
Decision Date 04/23/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Clinical Trials NCT05857943
Reviewed by Third Party No
Combination Product No
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