# FCT: Headlight, Fiberoptic Focusing

- Device class: 2; regulation: 21 CFR 886.4335; FDA's rule: 510(k) exempt
- FDA decisions: 6
- 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)
- 1978: 1
- 1980: 2
- 1988: 1
- 1992: 1
- 1996: 1

## Most-cited predicates

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