# K061690: Surgical Headlight

- Pathway: 510(k) (Traditional)
- Applicant: Gulf Medical Fiberoptics
- Decided: Sep 15, 2006 after 92 days
- Product code: FST (Light, Surgical, Fiberoptic)
- Device class: 2
- Regulation: 21 CFR 878.4580
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- May 13, 2011 · Not classified · Z-0831-2012: Gulf Medical Fiberoptics, Inc. recalled their Surgical Headlight because the cleaning instructions for the exterior surfaces of the headlight , headgear and fiber cable with 70% isopropyl alcohol had 

## Indications for use
The use for this particular device is to be worn on the surgeons head and to illuminate the body cavity during examinations or surgical procedures. This product is shipped to the end user non-sterile.

Source page: https://510kreport.com/device/K061690
Methodology: https://510kreport.com/methodology