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Kleresca® Receives CE Mark Approval for the Next Generation Biophotonic System in Dermatology


Kleresca® Receives CE Mark Approval for the Next Generation Biophotonic System in Dermatology

PR Newswire

COPENHAGEN, Denmark, August 16, 2018 /PRNewswire/ -- Kleresca®, a medical technology company focused on the development and commercialisation of a unique biophotonic technology in dermatology, today announced they have received CE mark approval for their technology platform.  

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.

"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", said Mr. Mikkel Schoedt, General Manager of Kleresca®.

Until end of June this year, Kleresca® operated under the CE mark of one of its founding fathers, LEO Pharma.  

Today's CE mark approval enables Kleresca® to consolidate its business on the European market as an independent company and paves the way for future market activities in the US, Australia and Canada as the company expects to apply the Medical Device Single Audit Program (MDSAP) on top of the CE Mark before the end of this year. At the same time, the company has also been successfully certified towards ISO 13485:2016.

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. 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.

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.

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