# K991572: Isolux Surgical Headlight

- Pathway: 510(k) (Traditional)
- Applicant: Isolux America
- Decided: Jul 8, 1999 after 64 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
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K071218: Proxenon 350, Model 902XX (2007), 1 descendant of its own
- K093386: Chromalume Turbo Light Source with Xtremebeam Fiber Optic Headlampfst Model FST (2010), 0 descendants of its own
- 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 ISOLUX America's Surgical Headlight is indicated for illumination purposes from an illuminator to a headlight to aid in providing illumination to body cavities during examinations or surgical procedures,

Source page: https://510kreport.com/device/K991572
Methodology: https://510kreport.com/methodology