For Kleresca, the CE mark approval is the foundation for future expansion in both Europe, US, Canada and Australia. It confirms that the product meets the requirements of the European Medical Device Directive.

Kleresca general manager Mikkel Schoedt said: “The CE mark approval is a significant accomplishment for Kleresca as it is based on a quality management system that we have tailored to our business from scratch securing a high degree of flexibility and agility in our day to day work while still being compliant.

“This degree of flexibility is important for us to be able to continue growing in a rapidly changing market.”

To date, Kleresca has built a strong partner structure counting more than 250 skin clinics in key markets leveraging gentle, non-invasive skin treatments with high efficacy and safety currently indicated for therapeutic (acne) and aesthetic (skin rejuvenation) purposes.

The Kleresca biophotonic system uses fluorescent light energy to stimulate the skin’s own biological processes and repair mechanisms. It has been available on the market since 2014.

With the new CE-mark, the technology has furthermore been secured for treatment of rosacea as well as a pre-post treatment as an add on treatment to other dermatological procedures like IPL and laser treatments.

Source: Company Press Release