# Digital Therapy Device For Convergence Insufficiency
> **Product code: SBN** · Class I — Low Risk (general controls) · Ophthalmic · 21 CFR 886.1290
## Classification
- **FDA Product Code:** SBN
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 886.1290
- **Review panel:** OP
- **Medical specialty:** Ophthalmic
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

A digital therapy device for convergence insufficiency is an electronic device that incorporates binocular presentations on visual displays to treat convergence insufficiency

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 2
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=SBN)
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