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Dornier Diode Laser Family

FDA 510(k)

Class II (US FDA 510(k))

510(k) K021724

by Dornier MedTech America, Inc.

Identifiers

510(k) Number
K021724 FDA 510(k)
FDA Product Code
GEX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4810 FDA 510(k)
Regulation Number
878.4810 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Dornier Diode Laser family, including the Medilas D Fibertom, Medilas D Skinpulse, and Medilas D Skinpulse S, consists of diode laser systems designed for surgical and minimally invasive procedures. These systems utilize a 940 nm wavelength to perform various clinical applications.

This device family is supplied by Dornier MedTech America, Inc. and has received FDA 510k clearance. The systems are categorized under product code GEX for use in general and plastic surgery settings.

Frequently asked questions

What clinical applications are the Dornier Diode Laser systems designed for?

These diode laser systems are designed for use in general and plastic surgery settings. They utilize a 940 nm wavelength to perform various surgical and minimally invasive clinical procedures.

Which models are included in the Dornier Diode Laser family?

The device family includes the Medilas D Fibertom, the Medilas D Skinpulse, and the Medilas D Skinpulse S laser systems.

What is the regulatory status of the Dornier Diode Laser family?

The Dornier Diode Laser family has received FDA 510k clearance. This indicates that the systems have been determined to be substantially equivalent to legally marketed predicate devices.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Lasers & Fibers — Dornier MedTech Americas, Dornier MedTech - A Leading Urological Medical Device Company, Home - Lindauer DORNIER GmbH, Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D ..., Dornier Medilas D MultiBeam Overview | PDF | Laser | Optical Fiber

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Dornier MedTech America, Inc.

Sources (1)

  • FDA 510(k) K021724 24 fields · synced Oct 6, 2026