No, we use technology that is used with other 510k exempt products. Within the EU, the intended use of Luminousred LED Lights does not intend to cure, diagnose or treat any disease but uses certain wavelengths and mixtures of light that interact with the Mitochondria to potentially increase physical and mental resilience. Which can have the following effects, among others: optimized sleep, enhanced mental and physical performance, improved relaxation, recovery, and skin complexion.