# K013511: Xenalight Models # AX9125 (100-120V~); # AX9225 (220-240V~)

- Pathway: 510(k) (Traditional)
- Applicant: Aculux, Inc.
- Decided: Feb 1, 2002 after 102 days
- Product code: FSW (Light, Surgical, Endoscopic)
- 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.
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.

## Indications for use
The XenaLight™ Fiberoptic Illuminator, also known as a lightsource, is attached to a fiberoptic cable transmitting the light to a fiberoptic headlamp, retractor, endoscopic instrument, etc, providing light to the surgical operating field. This light is utilized in many different surgical procedures requiring additional light when overhead lighting is not sufficient. The fiberoptic cable and/or headlamps are an accessory to the XenaLight™ Fiberoptic Illuminator to transmit the light from the lightsource.

Source page: https://510kreport.com/device/K013511
Methodology: https://510kreport.com/methodology