510(k) K232930
- Device
- VERVE
- Applicant
- Oculomotor Technologies
- 510(k) number
- K232930
- Product code
- SBN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-06-13
- Date received
- 2023-09-20
- Regulation
- 886.1290
- Classification name
- Digital Therapy Device For Convergence Insufficiency
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Chang Yaramothu, Ph.D.
- Address
- 155 Village Blvd., Suite 130 Princeton NJ US 08540 08540
FDA Registration Numbers#
- 1424785
- 3023810198