510(k) K232930

VERVE by Oculomotor Technologies — Product Code SBN

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 13, 2024
Date Received: September 20, 2023
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Digital Therapy Device For Convergence Insufficiency
Device Class: Class I
Regulation Number: 886.1290
Review Panel: OP
Submission Type

A digital therapy device for convergence insufficiency is an electronic device that incorporates binocular presentations on visual displays to treat convergence insufficiency