# K971057: Cogenlight Technologies XLS Illuminator System

- Pathway: 510(k) (Traditional)
- Applicant: Cogent Light Technologies, Inc.
- Decided: Mar 28, 1997 after 4 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Cogent Light Technologies Illuminator System: named in the summary without a submission number

## Most influential descendants
- K993314: Synthes Light Guide (1999), 0 descendants of its own

## Indications for use
Both devices are intended for the same use, that of providing visible light for the illumination of surgical headlights and various rigid or flexible endoscopes that contain fiber bundles for illumination. Applications for both systems include, but are not limited to, externally illuminated endoscopes used in arthroscopy, bronchoscopy, gynecology, laparoscopy, obstetrics, oto-rhino-laryngoscopy, urology, and vascular endoscopy.

Source page: https://510kreport.com/device/K971057
Methodology: https://510kreport.com/methodology