# K022384: Xenon Fiberoptic Light Source, Model 1300 XSBP

- Pathway: 510(k) (Traditional)
- Applicant: Isolux America
- Decided: Oct 18, 2002 after 88 days
- Product code: HET (Laparoscope, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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 III: named in the summary without a submission number

## Most influential descendants
- K061622: PS Series (2007), 0 descendants of its own
- K070287: PS Series with Fiber Light Guide and Headlight, Models PS200, PS250, PS500 (2007), 0 descendants of its own

## Indications for use
The 1300 XSBP - 300 WATT XENON Illuminator is intended for use as a high intensity right to be used with fiberoptic cables. Applications include endoscopes, surgical headlights and other tools that contain 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 vascula endoscopy. The device is also intended for use as a light source for surgical headlights used in various open surgical procedures.

Source page: https://510kreport.com/device/K022384
Methodology: https://510kreport.com/methodology