# K980044: Xenon 300MX

- Pathway: 510(k) (Traditional)
- Applicant: Perkinelmer Optoelectronics
- Decided: Apr 3, 1998 after 87 days
- Product code: FSS (Light, Surgical, Floor Standing)
- Device class: 2
- Regulation: 21 CFR 878.4580
- 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) Karl Storz Cold Light Fountain Xenon 300: named in the summary without a submission number
- (no number) Maxenon: named in the summary without a submission number
- (no number) Brite Lite II: named in the summary without a submission number

## Most influential descendants
- K984124: Aesculap Xenon Light Source (1999), 0 descendants of its own

## Indications for use
The Xenon 300mx Illuminator is intended for use as a high intensity light to be used with Fiberoptic cables. Applications include endoscopes, surgical headlamps, and other lighted tools that contained Fiberoptic bundles. Illumination from this device is intended to be used for observation of body cavities, hollow organs, and other surgical sites. Specific areas of application include arthroscopy, laproscopy, gynecology, broncoscopy, urology, and vascular endoscopy. The device is also intended for use as a light source for surgical headlights used in various open surgical procedures. These indications are identical to those listed in the Cogent 510(k) number K971057.

Source page: https://510kreport.com/device/K980044
Methodology: https://510kreport.com/methodology