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Mcl 29 Dermablate Erbium Laser System

by Aesculap-Meditec GmbH

510(k) K964128

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberK964128 Date17 Mar 1997ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
GEX
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 MCL 29 Dermablate Er:YAG Laser System is a floor-standing laser device classified as an Erbium:Yttrium Aluminum Garnet (Er:YAG) laser (Device Type: GEX). It emits laser energy at a wavelength of 2.94 micrometers, enabling precise tissue ablation for dermatological and surgical applications, including site preparation in hair transplantation procedures.

This system is intended for use in clinical settings by licensed professionals, operating as a surgical laser instrument. It is supplied as a reusable medical device, with no indication of sterility requirements in the provided data. The device is authorised under an FDA 510(k) clearance (K964128) and falls under the advisory committee for General and Plastic Surgery. No MRI safety or single-use specifications are noted.

Other devices from Aesculap-Meditec GmbH

Questions

AI-generated answers, 19 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 types of medical procedures is the MCL 29 Dermablate Er:YAG Laser System primarily used for in clinical settings?

    The MCL 29 Dermablate Er:YAG Laser System is designed for dermatological and surgical applications, particularly for precise tissue ablation. Clinically, it is commonly used for site preparation in hair transplantation procedures, as well as other dermatological treatments requiring controlled removal of tissue layers.

  • Is the MCL 29 Dermablate Er:YAG Laser System intended for single-use or can it be reused in a clinical environment?

    The MCL 29 Dermablate Er:YAG Laser System is explicitly described as a reusable medical device. Since it is not labeled as single-use, it must be properly cleaned, maintained, and processed according to clinical protocols to ensure safety and functionality between uses.

  • What wavelength does the MCL 29 Dermablate Er:YAG Laser System emit, and how does this affect its clinical applications?

    The device emits laser energy at a wavelength of 2.94 micrometers, which is characteristic of Erbium:Yttrium Aluminum Garnet (Er:YAG) lasers. This wavelength allows for precise and controlled tissue ablation, making it particularly effective for dermatological procedures where minimal thermal damage to surrounding tissue is desired.

  • How is the MCL 29 Dermablate Er:YAG Laser System authorized for use in the United States?

    The MCL 29 Dermablate Er:YAG Laser System holds an FDA 510(k) clearance (K964128), which means it has been determined to be substantially equivalent to a legally marketed device already on the market. The clearance was granted under the General and Plastic Surgery advisory committee, indicating its intended use aligns with surgical and dermatological procedures.