Our seals of approval, approvals and guarantee

Our devices are subject to the highest safety standards and have worldwide
Approvals, for safe operation.

U. S. Food and Drug Administration

The FDA (Food and Drug Administration) in the USA is the only official federal authority in the world that has laser and IPL devices tested for their effectiveness for permanent hair reduction at the request of the manufacturer (510(k) approval).

To be allowed to work with a device in the USA, it must have the "normal" FDA approval. Similar to the CE certification in the EU, the device is tested for safety and harmlessness. All devices on the US market have this FDA seal.

The FDA does not differentiate between lasers and IPL devices in the approval process. For simplicity, both types of devices fall under the existing category of dermatological and surgical lasers class 2 (CFR 878.4810). In official statements of the FDA, only lasers are mentioned although IPL is also included.

TÜV Süd

The road to the various markets is paved with extremely strict requirements, especially in the medical products sector: the products must meet the highest quality standards and their quality management must be designed accordingly. Here it is sensible and good to be able to consult an experienced expert. Just like TÜV SÜD. We have been testing and certifying quality management for medical devices for over 30 years and have the necessary know-how, not least thanks to the continuous training of our specialists. This is why we are among the market leaders in countries with strict regulation of medical devices and count many leading manufacturers among our customers. Our quality management certificates confirm that we comply with a whole range of international standards - most notably ISO 13485, which means that you as a manufacturer have proof that certified quality management has been applied in the manufacture of your medical devices and that it meets the highest requirements. This promotes your image as a manufacturer, strengthens the confidence of authorities, buyers and users in your products and provides clear sales arguments.

ISO 13485

Companies that develop and manufacture medical devices ensure the marketing and manufacturing processes by means of a comprehensive quality management system in accordance with ISO 13485. The basis is that for medical devices that are established on the German market, regulations and legal requirements must be observed: Medizinproduktegesetz (MPG), which together with its ordinances implements the European Directives 90/385/EEC (for active implants), 93/42/EEC (for other medical devices) and 98/79/EC (for in-vitro diagnostics) in Germany. The EN ISO 13485 standard describes the specific requirements for quality management systems in the medical device industry. Added to this is the position in EN ISO 9001 and other industry-specific conditions for medical devices.

Although ISO 13485 is an independent document, the requirements are largely identical to those of ISO 9001, which focuses on the requirement that companies/organizations must strive for continuous optimization under quality management aspects. ISO 13485 focuses on product safety. It is important to ensure that the efficiency of the implemented processes meets the product requirements.

Medical devices - seal of approval

The EN ISO 13485 standard "Medical devices: Quality management systems - Requirements for regulatory purposes" deals with the requirements that manufacturers and suppliers of medical devices must meet when developing, implementing and maintaining management systems for the medical device industry. Originally developed in the 1990s, the standard contains requirements for quality management systems that meet customer needs as well as regulatory requirements of the European Union (EU), Canada and other major markets worldwide.

EN ISO 13485 is similar in scope and purpose to ISO 9001, but contains additional requirements specific to medical devices and reformulates some of the requirements of ISO 9001. In most markets, ISO 9001 certification is therefore not an adequate substitute for EN ISO 13485 certification.

ECM – Ente Certificazione Macchine

Ente Certificazione Macchine is a well-known body authorized by the European Commission to issue EC certificates in accordance with Directive 93/42/EEC (MDD). [See the ECM accreditations on the database Nando Information System qui of the European Commission].

The CE mark The CE mark is the mandatory certification mark that every medical device must have in order to be marketed and used in the European Union. The CE mark declares that the product complies with the applicable European directives. The Medical Device Directive 93/42/EEC (MDD) lists the basic safety, efficacy and quality requirements that a medical device must meet in order to receive the CE mark and be allowed to be placed on the European market.

EU  765/2008

The CE marking indicates that the machine meets the requirements of the Machinery Directive. This also applies to all other applicable EC directives. Each machine may be provided with exactly one CE mark. The CE marking must stand on an equal footing with the manufacturer's information and be applied using the same technique.

CE stands for Communauté Européenne (European Community). The marking indicates that a product or machine complies with the relevant European directives. The CE mark, introduced in 1995, is therefore to be understood as a "passport" for machines, as it allows machines to be both marketed and operated in the EU. It is important that the CE mark should not be confused with a seal of approval or quality mark.

For further information and questions, please contact us.


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