# K992540: Xenon Light Source Pes 1

- Pathway: 510(k) (Traditional)
- Applicant: Laser Optik Systeme GmbH & Co. KG
- Decided: Sep 14, 1999 after 47 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The indication for use of the Xenon Light Source PES 1 is to provide illumination for fiberoptic endoscopy to gastroenterological cavities, urological, gynecological and ENT cavities, hollow organs and canals. The PES 1 replaces current equipment in this branch. Operation is only allowed in medically used rooms in which the electrical installation meets the safety requirements of national standards (e.g. VDE 0107). The device is not intended for direct application at the heard or central nerve system.

Source page: https://510kreport.com/device/K992540
Methodology: https://510kreport.com/methodology