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MateLaser Medical Diode Laser Systems ML-DLS-30

by Matelaser, Inc.

510(k) K250731

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK250731 Date16 Oct 2025ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

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  • Withdrawn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
NVK
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

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

The MateLaser Medical Diode Laser Systems ML-DLS-30 is a medical diode laser device designed for soft tissue applications. It features a user interface that allows operators to configure treatment parameters, including wavelength selection at 445nm, 660nm, or 970nm, as well as power settings, duty cycle, frequency, and treatment time.

This device has received FDA 510(k) clearance under K250731. It is classified as a Class 2 device under regulation number 878.4810 and is intended for use in general and plastic surgery settings.

Other devices from Matelaser, Inc.

Questions

AI-generated answers, 26 Sep 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 intended use of the MateLaser ML-DLS-30?

    The MateLaser ML-DLS-30 is designed for soft tissue applications within general and plastic surgery settings. It is a medical diode laser system that allows clinicians to perform procedures by configuring specific treatment parameters.

  • Which wavelengths are available on this diode laser system?

    This device offers versatility by allowing operators to select from three specific wavelengths: 445nm, 660nm, or 970nm, depending on the requirements of the soft tissue procedure.

  • What regulatory information is associated with this device?

    The MateLaser ML-DLS-30 has received FDA 510(k) clearance under K250731. It is classified as a Class 2 device under regulation number 878.4810, which pertains to laser surgical instruments for use in general and plastic surgery.

  • What parameters can be adjusted by the operator?

    The device features a user interface that enables the operator to customize treatment settings including wavelength selection, power output, duty cycle, frequency, and total treatment time to suit the clinical application.