# K031994: Linvatec 300W Xenon Light Source

- Pathway: 510(k) (Traditional)
- Applicant: Linvatec Corp.
- Decided: Aug 21, 2003 after 55 days
- Product code: GCT (Light Source, Endoscope, Xenon Arc)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K962595 (1996). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962595: Karl Storz Xenon 300 Light Source for Non-Flash Applications, KARL STORZ Endoscopy-America, Inc. (1996) Summary page 2.
- K021717: Endoscopic Light Source, Model XL300/L5, World of Medicine Lemke GmbH (2002) Summary page 2.

## Most influential descendants
- K093125: Alphaxenon Light 180 W and 300 W (2010), 0 descendants of its own
- K070376: Conmed Linvatec 300W Xenon Light Source (2007), 0 descendants of its own

## Recalls of this device
- Aug 1, 2005 · Not classified · Z-1531-05: Through the complaint handling system, the company has determine there are performance issued involving the LS7500, 300 Watt Xenon Light Source. The performance issues result in a low light output tha

## Indications for use
The Linvatec 300W Xenon Light Source is intended to be used with an endoscope to provide illumination during endoscopic procedures.

Source page: https://510kreport.com/device/K031994
Methodology: https://510kreport.com/methodology