BioPhotas, the manufacturer of aesthetic device company Celluma, has received certification with the European Council Medical Device Regulation 2017/745 for low level light therapy devices.
According to the company, BioPhotas is the first low-level light therapy device manufacturer to be certified to the new MDR standards, which is designed to guarantee clinical safety through a stringent regulation process.
Patrick Johnson, chief
executive officer of BioPhotas said, “This certification represents a major
milestone for BioPhotas and means that in addition to its legacy products, the
Celluma RESTORE for hair restoration will be available in the European Union
and other countries that rely on certification to the MDR. Demonstrating
compliance to the MDR requirements has been a daunting task for medical device
manufacturers around the world, and after a multi-year effort, we are proud to
say our products comply with the most rigorous regulatory requirements around the
world.”
