What authoritative certifications do Sunsred’s red light therapy masks have? Which international standards do they meet?

Sunsred regards safety and compliance as the highest principles; our products have obtained authoritative "passports" for major global markets!

Our red light therapy masks possess a comprehensive range of international certifications and strict compliance standards:

Global Authoritative Certifications:

FDA 510K: Obtained the US Food and Drug Administration's 510K Premarket Notification clearance, which is a key qualification for entering the US medical market.

CE, FCC, RoHS: Passed the EU CE safety certification, US FCC electromagnetic compatibility certification, and RoHS environmental certification, ensuring products meet the regulatory requirements of major global markets.

Rigorous Testing Standards:

EN 62471: Passed photobiological safety testing.

EN 55014 / 60601-1-2: Compliant with electromagnetic compatibility standards.

IEC 60601-1: Meets general standards for safety of medical electrical equipment.

Excellence in Quality Management Systems:

ISO 9001 & ISO 13485: Certified by international quality management systems and medical device quality management systems.

ISO 10993-1: Compliant with biological evaluation standards for medical devices.

Need compliant market access documents? Contact the sales team to get complete certification reports! www.sunsred.com