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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Digital Therapy Device For Convergence Insufficiency
510(k) Number K232930
Device Name VERVE
Applicant
OculoMotor Technologies
155 Village Blvd, Suite 130
Princeton,  NJ  08540
Applicant Contact Chang Yaramothu, Ph.D.
Correspondent
Rqm+
2251 San Diego Ave., Suite B-257
San Diego,  CA  92110
Correspondent Contact Allison Komiyama, Ph.D., RAC
Regulation Number886.1290
Classification Product Code
SBN  
Date Received09/20/2023
Decision Date 06/13/2024
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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