510(k) K232930
K232930 is an FDA 510(k) premarket notification submitted by Oculomotor Technologies for the device "VERVE". The FDA issued a decision of Substantially Equivalent on June 13, 2024. The device falls under product code SBN (Digital Therapy Device For Convergence Insufficiency), a Class I device regulated under 21 CFR 886.1290.
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