# K093386: Chromalume Turbo Light Source with Xtremebeam Fiber Optic Headlampfst Model FST

- Pathway: 510(k) (Traditional)
- Applicant: Bfw, Inc.
- Decided: Jan 28, 2010 after 90 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: 2 generations back to K991572 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071218: Proxenon 350, Model 902XX, Welch Allyn, Inc. (2007) Summary page 1.

## Indications for use
The ChromaLUME Turbo Light Source is designed for use with fiber optic headlight systems to supply high intensity light through the fiber optic cable for illumination of a surgical field. The ChromaLUME Turbo Light Source will accommodate fiber optic cables from Wolf, Storz, Olympus and ACMI/BFW products. The XtremeBeam Fiber Optic Headlamp is a passive luminary which is illuminated by the fiber optic light to provide supplemental light for surgical procedures.

Source page: https://510kreport.com/device/K093386
Methodology: https://510kreport.com/methodology