Clinical Trials Exempted | Regis Group Assists in the Launch of a 2-in-1 IPL & RF Therapy Device

Regis Group successfully assisted a Class III Intense Pulsed Light (IPL) and Radio Frequency (RF) Therapy Device in obtaining NMPA registration approval through the Equivalent Device Clinical Evaluation (CER) pathway.

The product is an intelligent skin rejuvenation platform integrating IPL and multi-frequency RF technologies on a single platform. It covers three major dimensions—skin tone, skin texture, and skin age—providing beauty seekers with an intelligent, one-stop skin rejuvenation solution.

During the registration process, the Regis Group team selected multiple clinically commonly used competitor products as equivalent devices to match the 2-in-1 function of the applied product. We thoroughly collected various clinical and non-clinical data and clearly demonstrated the basis for all parameters. Ultimately, the product passed the NMPA review and successfully obtained market approval.