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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Ophthalmic, Ac-Powered
510(k) Number K250770
Device Name Optina-4C (MHRC-C1N)
Applicant
Optina Diagnostics, Inc.
8200 Blvd. Decarie
Montreal,  CA H4P 2P5
Applicant Contact Sarah Lemaire
Correspondent
Optina Diagnostics, Inc.
8200 Blvd. Decarie
Montreal,  CA H4P 2P5
Correspondent Contact Sarah Lemaire
Regulation Number886.1120
Classification Product Code
HKI  
Date Received03/13/2025
Decision Date 09/04/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Clinical Trials NCT05903651
NCT06057493
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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