# FCW: Light Source, Fiberoptic, Routine

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) exempt
- FDA decisions: 31
- Recalls: 4 (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)
- 1999: 2
- 2000: 1
- 2001: 1
- 2003: 1
- 2008: 2
- 2009: 1
- 2010: 1
- 2012: 2
- 2013: 1
- 2014: 1

## Most-cited predicates
- K082813: Stryker Led Lightsource (2008), cited by 6
- K093792: Led Light Source (2010), cited by 4
- K091968: Karl Storz Led Nova 100 Cold Light Fountain, Models 2016020, 20161020C (2009), cited by 2
- K951647: Welch Allyn HI - Lux Illuminator (1995), cited by 2
- K121724: Endolight Led 1.1 Endolightled 1.2 (2012), cited by 1
- K012265: Metal Halide Light Source, Models MV-9088-T, MV-9088 (2001), cited by 1
- K890716: Luxtec Aco Series 4000 Light Source (1989), cited by 1
- K123956: Power Led 175 (2013), cited by 1
- K123359: OVS1 Video System (2012), cited by 1
- K905376: Storz S6000 Light Source (1991), cited by 1

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