Alix Lasers® Safety and Certifications
Alix Lasers® equipment adheres to the highest safety standards and has received global approvals for safe operation.
TÜV Süd Certification for All Diode Lasers
TÜV SÜD has been testing and certifying quality management systems for medical devices for over 30 years. This makes TÜV SÜD a market leader in countries with strict medical device regulations. Our products are certified to meet international standards, primarily ISO 13485.
ISO 13485 Standard
The international EN ISO 13485 standard is essential for market entry in many countries. It focuses on product safety and the effectiveness of implemented processes.
ECM – Ente Certificazione Macchine
ECM is authorized by the European Commission to issue EC certificates according to Directive 93/42/EEC (MDD). The CE Mark is mandatory for marketing and usage in the European Union.
EU Regulation 765/2008
The CE marking indicates compliance with the Machinery Directive and all other applicable EC directives. It serves as a passport for machines to be marketed and operated in the EU.
FDA 510 K
Food and Drug Administration (FDA) approval is required for distributing medical devices in the United States. Our quality management system complies with FDA regulation QSR 21CFR820.