# K081477: Luxtec MLX Light Source

- Pathway: 510(k) (Traditional)
- Applicant: Integra Luxtec, Inc.
- Decided: Jun 18, 2008 after 22 days
- Product code: FCW (Light Source, Fiberoptic, Routine)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 4 (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
- Oct 14, 2011 · Not classified · Z-0357-2012: A loose screw may result in shifting of components and improper function of the turret or actuator assembly.
- Oct 14, 2011 · Not classified · Z-0358-2012: A loose screw may result in shifting of components and improper function of the turret or actuator assembly.
- Oct 14, 2011 · Not classified · Z-0356-2012: A loose screw may result in shifting of components and improper function of the turret or actuator assembly.
- Mar 7, 2011 · Not classified · Z-2060-2011: Malfunction of the MLX Control Board may cause loss of manual control and Lamp shut down.

## Indications for use
The Integra LUxtec MLX Light Source is designed to supply high intensity white light through a fiber optic cable for illumination of a surgical field during a surgical and/or medical procedure. The Integra Luxtec MLX Light Source should, never be used in ocular surgery or in a surgical procedure requiring direct illumination of the eye.

Source page: https://510kreport.com/device/K081477
Methodology: https://510kreport.com/methodology