# GCT: Light Source, Endoscope, Xenon Arc

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) exempt
- FDA decisions: 47
- Recalls: 1 (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)
- 1997: 1
- 1998: 4
- 1999: 2
- 2001: 1
- 2002: 2
- 2003: 3
- 2004: 1
- 2007: 1
- 2008: 1
- 2010: 1

## Most-cited predicates
- K021717: Endoscopic Light Source, Model XL300/L5 (2002), cited by 4
- K983628: Xenon Light Source Auto Lip 5123, Model 2123.011 (1998), cited by 3
- K934559: Karl Storz Xenon Light Source Model 201320-20 (1994), cited by 3
- K031994: Linvatec 300W Xenon Light Source (2003), cited by 2
- K952696: Xenon Light Source Model 5121 (1995), cited by 2
- K944607: Model 5135 Auto LP/Flash (1994), cited by 2
- K954561: Xenon Noppva (1995), cited by 2
- K944821: MODEL 5151 (1994), cited by 2
- K933868: Angiolaz Video Endoscopic System Model CAMLUM1 and Accessories (1993), cited by 1
- K971057: Cogenlight Technologies XLS Illuminator System (1997), cited by 1

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