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MedioStar Next

FDA 510(k)

Class II (US FDA 510(k))

510(k) K111851

by Asclepion Laser Technologies GmbH

Identifiers

510(k) Number
K111851 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 MedioStar Next is a laser device classified under product code GEX, which corresponds to general and plastic surgery applications. It is a diode laser system designed for professional use in aesthetic procedures, specifically laser epilation (hair removal).

The device received FDA 510(k) clearance (K111851) on July 8, 2011, and was found substantially equivalent to a predicate device. It is manufactured by Asclepion Laser Technologies GmbH in Jena, Germany, and is supplied as a reusable medical equipment system requiring user training and adherence to operational guidelines outlined in its user manual.

Frequently asked questions

What is the MedioStar Next used for?

The MedioStar Next is a diode laser system designed for professional use in aesthetic procedures, specifically laser epilation (hair removal). It is classified under product code GEX, which corresponds to general and plastic surgery applications, and is intended for hair removal treatments performed by trained users.

Is the MedioStar Next a single-use or reusable device?

The MedioStar Next is supplied as a reusable medical equipment system. It is not intended for single use and requires proper maintenance, user training, and adherence to operational guidelines outlined in its user manual to ensure safe and effective repeated use.

What regulatory clearance does the MedioStar Next have?

The MedioStar Next received FDA 510(k) clearance (K111851) on July 8, 2011, and was found substantially equivalent to a predicate device. This clearance permits its marketing for the intended use in laser epilation under the product code GEX for general and plastic surgery applications.

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: MeDioStar - High-Power diode technology for professional laser epilation, MeDioStar_EN - ASCLEPION, ASCLEPION MEDIOSTAR NEXT USER MANUAL Pdf Download, MeDioStar DE - High-Power diode technology for professional laser epilation, Asclepion | Laser technology for Aesthetic Medicine & Surgery

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Asclepion Laser Technologies GmbH

Sources (1)

  • FDA 510(k) K111851 24 fields · synced Sep 25, 2026