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Luxtec Mlx Light Source

by Integra Luxtec, Inc.

510(k) K081477

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK081477 Date18 Jun 2008ClearedStatusActive

Recalls

4 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-0358-2012 FDA Unclassified (pre-2012) initiated 14 Oct 2011
    • Terminated Z-0356-2012 FDA Unclassified (pre-2012) initiated 14 Oct 2011
    • Terminated Z-0357-2012 FDA Unclassified (pre-2012) initiated 14 Oct 2011

    A loose screw may result in shifting of components and improper function of the turret or actuator assembly.

    • Terminated Z-2060-2011 FDA Unclassified (pre-2012) initiated 7 Mar 2011

    Malfunction of the MLX Control Board may cause loss of manual control and Lamp shut down.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FCW
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Luxtec MLX Light Source is a fiberoptic light source designed to provide high-intensity white light for the illumination of a surgical field. It functions as a xenon light source that delivers cool white, infrared-filtered light through a fiber optic cable.

This device is intended for use in clinical settings such as gastroenterology and urology. It has received FDA 510(k) clearance.

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the Luxtec MLX Light Source?

    The Luxtec MLX Light Source is a xenon-based fiberoptic device designed to provide high-intensity, cool white, infrared-filtered light for illuminating surgical fields.

  • In which clinical specialties is this device used?

    This light source is intended for use in clinical settings specifically within the fields of gastroenterology and urology.

  • How does the Luxtec MLX deliver light to the surgical site?

    The device operates by delivering light through a fiber optic cable to ensure the surgical field is properly illuminated during procedures.

  • What is the regulatory status of the Luxtec MLX Light Source?

    The Luxtec MLX Light Source has received FDA 510(k) clearance, which indicates it has been determined to be substantially equivalent to other legally marketed devices.