SBN — Digital Therapy Device For Convergence Insufficiency Class I
FDA product code SBN covers "Digital Therapy Device For Convergence Insufficiency", a Class I medical device regulated under 21 CFR 886.1290. Submissions are reviewed by the Ophthalmic panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SBN
- Device Class
- Class I
- Regulation Number
- 886.1290
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Definition
A digital therapy device for convergence insufficiency is an electronic device that incorporates binocular presentations on visual displays to treat convergence insufficiency
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K232930 | oculomotor technologies | VERVE | June 13, 2024 |