# K093125: Alphaxenon Light 180 W and 300 W

- Pathway: 510(k) (Abbreviated)
- Applicant: Gimmi GmbH
- Decided: Jan 27, 2010 after 117 days
- Product code: GCT (Light Source, Endoscope, Xenon Arc)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K962595 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031994: Linvatec 300W Xenon Light Source, Linvatec Corp. (2003) Summary page 1.
- K962595: Karl Storz Xenon 300 Light Source for Non-Flash Applications, KARL STORZ Endoscopy-America, Inc. (1996) Summary page 1.
- K021717: Endoscopic Light Source, Model XL300/L5, World of Medicine Lemke GmbH (2002) Summary page 1.

## Indications for use
AlphaXenon Light 300W and 180W light source is used with an endoscope to provide illumination during endoscopic procedures.

Source page: https://510kreport.com/device/K093125
Methodology: https://510kreport.com/methodology