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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 K223357
Device Name EyeArt v2.2.0
Applicant
Eyenuk, Inc.
5850 Canoga Ave, Suite 250
Los Angeles,  CA  91367
Applicant Contact Kaushal Solanki
Correspondent
Eyenuk, Inc.
5850 Canoga Ave, Suite 250
Los Angeles,  CA  91367
Correspondent Contact Kaushal Solanki
Regulation Number886.1100
Classification Product Code
PIB  
Subsequent Product Codes
HKI   MYC  
Date Received11/02/2022
Decision Date 06/16/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Clinical Trials NCT03112005
NCT04984200
Reviewed by Third Party No
Combination Product No
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