# QQU: Digital Therapy Device For Amblyopia

- Device class: 2; regulation: 21 CFR 886.5500; FDA's rule: 510(k) required
- FDA decisions: 5
- 510(k) review time 2021–2025: median 145 days (middle half 135–177)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2021: 1
- 2022: 2
- 2024: 1
- 2025: 1

## Most-cited predicates
- DEN210005: Luminopia One (2021), cited by 2
- K221659: Luminopia One (2022), cited by 1
- K233720: Luminopia (2024), cited by 1

Source page: https://510kreport.com/product-code/QQU
Data by year (CSV): https://510kreport.com/product-code/QQU.csv