Dermatological device developer Kleresca said yesterday it won CE Mark approval in the European Union for its biophotonic dermatological technology platform.
The Kleresca biophotonic system uses fluorescent light energy to stimulate biological processes and repair mechanisms in the skin, the company said.
Kleresca said that hte clearance will allow it to “consolidate its business on the European market as an independent company and paves the way for future market actirivites in the US, Australia and Canada.” The company added that it expects to apply the Medical Deisng Single Audit Program on top of the CE Mark before the year ends.
“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,” GM Mikkel Schoedt said in a prepared statement.
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