# PLH: Orthodontic Led Accessory

- Device class: 2; regulation: 21 CFR 872.5470; FDA's rule: 510(k) required
- FDA decisions: 2
- 510(k) review time 2021–2025: median 70 days (middle half 70–70)
- 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)
- 2015: 1
- 2023: 1

## Most-cited predicates
- K143120: OrthoPulse (2015), cited by 2

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