Every Derma Rays device meets the most rigorous international safety and quality standards. Our certifications are not just checkboxes — they are proof of our commitment to clinicians and patients worldwide.
← Back to AboutDemonstrates conformity with EU health, safety, and environmental protection standards. Required for marketing medical devices across all EU member states.
Our SupraTitan platform received FDA 510(k) clearance for laser-based aesthetic treatments, confirming safety and effectiveness for the US market.
ISO 13485 certification confirms our quality management system meets the highest international standards for medical device design, development, and production.
GMP certification guarantees that all Derma Rays devices are consistently produced and controlled to quality standards appropriate for their intended use.