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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 K250683
Device Name Resolve Fundus Camera
Applicant
Optain Health, Inc.
373 Park Ave. S.
New York,  NY  10016
Applicant Contact Emilia Gonzalez
Correspondent
Oconnell Regulatory Consultants, Inc.
44 Oak St.
Stoneham,  MA  02180
Correspondent Contact Maureen OConnell
Regulation Number886.1120
Classification Product Code
HKI  
Date Received03/06/2025
Decision Date 04/30/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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