K232930 is an FDA 510(k) clearance for the VERVE. This device is classified as a Digital Therapy Device For Convergence Insufficiency (Class I - General Controls, product code SBN).
Submitted by Oculomotor Technologies (Princeton, US). The FDA issued a Cleared decision on June 13, 2024, 267 days after receiving the submission on September 20, 2023.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1290. A Digital Therapy Device For Convergence Insufficiency Is An Electronic Device That Incorporates Binocular Presentations On Visual Displays To Treat Convergence Insufficiency.
| 510(k) Number | K232930 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 20, 2023 |
| Decision Date | June 13, 2024 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | SBN - Digital Therapy Device For Convergence Insufficiency |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1290 |
| Definition | A Digital Therapy Device For Convergence Insufficiency Is An Electronic Device That Incorporates Binocular Presentations On Visual Displays To Treat Convergence Insufficiency |