FDA Medical Device

FDA Medical Device Certification is issued by the U.S. Food and Drug Administration (FDA) and confirms that our red light therapy lamps comply with U.S. medical device regulations, supporting legal market access and customer confidence.

Electrical Testing Laboratories

ETL certification, or the ETL Listed Mark, is a product safety certification that indicates a product meets North American safety standards. ETL stands for Electrical Testing Laboratories, and the certification is issued by Intertek, an international certification organization.

MDSAP Medical System

ISO 13485 & MDSAP: ILUXRED complies with ISO 13485 & MDSAP, an internationally recognized standard for quality management systems specific to the medical device industry.

Federal Communications  Commission's

FCC certification is a mandatory requirement in the United States that ensures electronic devices meet the Federal Communications Commission’s (FCC) standards for radio frequency interference and electromagnetic compatibility. It’s a mark of approval that indicates a product operates within specified parameters and doesn’t interfere with other electronic devices.

CE certification

applies to the European Union and the European Economic Area (EEA) market. It indicates that red light therapy products comply with EU regulations on safety, health, and environmental protection, and is a mandatory requirement for legal market access and sales within the EU.

UKCA Medical Device

The UKCA medical certificate is issued by a notified body (Approved Bodies) recognized by the British government, proving that the medical device product complies with the UK Medical Device Regulations.

Standards Association of Australia

Shenzhen ILUXRED Light products comply with Australian/New Zealand electrical safety standards + certification by an Australian accredited body