# K071218: Proxenon 350, Model 902XX

- Pathway: 510(k) (Traditional)
- Applicant: Welch Allyn, Inc.
- Decided: Jun 14, 2007 after 43 days
- Product code: FST (Light, Surgical, Fiberoptic)
- 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
Longest line of descent: 1 generation back to K991572 (1999). 1 ancestor in all.
1 later device descends from it; 1 cites 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)
- K991572: Isolux Surgical Headlight, Isolux America (1999) Summary page 1.

## Most influential descendants
- K093386: Chromalume Turbo Light Source with Xtremebeam Fiber Optic Headlampfst Model FST (2010), 0 descendants of its own

## Indications for use
The ProXenon 350 Light Source is designed for use with fiber optic, headlight systems. It will accept fiber optic light guides for Wolf, Storz, Olympus and ACMI instrumentation. Accessory Headlight is a passive luminaire that is illuminated by fiber optic light and utilized to provide supplemental light for surgical and medical procedures.

Source page: https://510kreport.com/device/K071218
Methodology: https://510kreport.com/methodology