# FSR: Light, Headband, Surgical

- Device class: 2; regulation: 21 CFR 886.4335; FDA's rule: 510(k) exempt
- FDA decisions: 4
- 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)
- 2000: 1
- 2003: 2
- 2011: 1

## Most-cited predicates
- K031548: Led Headlight (2003), cited by 1

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