# FST: Light, Surgical, Fiberoptic

- Device class: 2; regulation: 21 CFR 878.4580; FDA's rule: 510(k) required
- FDA decisions: 45
- Recalls: 11 (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)
- 2004: 1
- 2005: 1
- 2006: 2
- 2007: 1
- 2008: 2
- 2009: 3
- 2010: 5
- 2012: 3
- 2014: 1
- 2020: 1

## Most-cited predicates
- K042034: Nuvasive Maxcess Light Guide (2004), cited by 5
- K080367: Zimmer Mis Light (2008), cited by 3
- K991572: Isolux Surgical Headlight (1999), cited by 3
- K870942: MVS Fiberoptic Lightpipe (1987), cited by 2
- K901035: Fiber Optic Light Guide or Fiber Optic Cable (1990), cited by 2
- K875195: Ophthalmic Light Pipe Pick (1988), cited by 2
- K082992: Axxion Light Guide (2009), cited by 1
- K080962: Lite Wand II (2008), cited by 1
- K101496: Cablecap Model: WLF, STZ, Acm (2010), cited by 1
- K972225: Ufr Fiberoptic Cable (1998), cited by 1

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