FDA product code SBN: Digital Therapy Device For Convergence Insufficiency
SBN is the FDA product code for digital therapy device for convergence insufficiency. It is a Class I device, regulated under 21 CFR 886.1290 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under SBN, 1 in the last five years. The average 510(k) review took 267 days (median 267); 267 days on average over the last three years.
Definition
A digital therapy device for convergence insufficiency is an electronic device that incorporates binocular presentations on visual displays to treat convergence insufficiency
Classification
| Field | Value |
|---|---|
| Device name | Digital Therapy Device For Convergence Insufficiency |
| Device class | Class I |
| Regulation | 21 CFR 886.1290 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
510(k) clearances per year for SBN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 267 |
Compare with all 510(k) review times · Search every SBN clearance
Top SBN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Oculomotor Technologies | 1 | 2024-06-13 |
Most recent SBN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K232930 | Oculomotor Technologies | VERVE | 2024-06-13 | 267 |
Recalls for SBN devices
openFDA lists no recalls for product code SBN.
Frequently asked questions
What is FDA product code SBN?
SBN is the FDA product code for digital therapy device for convergence insufficiency. It is a Class I device, regulated under 21 CFR 886.1290 and reviewed by the Ophthalmic panel.
What device class is SBN?
Class I, regulation 21 CFR 886.1290. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code SBN?
Across 1 cleared submissions the average was 267 days from receipt to decision (median 267).
Which companies have the most SBN clearances?
Oculomotor Technologies (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SBN
- Run a recall and safety report across every SBN manufacturer
- Watch product code SBN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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