SBN
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Digital Therapy Device For Convergence Insufficiency
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1290
- Medical specialty
- Ophthalmic
- FDA definition
- A digital therapy device for convergence insufficiency is an electronic device that incorporates binocular presentations on visual displays to treat convergence insufficiency
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| VERVE (K232930) | Oculomotor Technologies | 2024-06-13 |
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