# Digital Therapy Device For Amblyopia
> **Product code: QQU** · Class II — Moderate Risk (510(k) clearance required) · Ophthalmic · 21 CFR 886.5500
## Classification
- **FDA Product Code:** QQU
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 886.5500
- **Review panel:** OP
- **Medical specialty:** Ophthalmic
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

A digital therapy device for amblyopia is a device that incorporates dichoptic presentations on visual displays through therapeutic algorithms to treat  amblyopia or to improve visual acuity of patients with amblyopia.

## Market data
- **Cleared 510(k) submissions:** 5
- **Registered establishments:** 2
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QQU)
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