The company announced it has received a medical device license from Health Canada and CE MArk from DEKRA Certification B.V.
Venus Concept (NASDAQ:VERO) has announced that it has received a medical device license from Health Canada and CE MArk from DEKRA Certification B.V. to market Venus Epileve.
As quoted in the press release:
It is intended as a treatment for hirsutism, permanent hair reduction and pseudofolliculitis barbae in Europe, and for hair removal, permanent hair reduction, and the treatment of pseudofolliculitis barbae in Canada.
Venus Epileve represents a new product introduction that expands the Company’s diode laser hair removal offering beyond the Venus Velocity which was introduced to the medical aesthetics market in 2017. The Venus Epileve is cost-effective, fast, comfortable, and can be used on all skin types (Fitzpatrick skin types I-VI), including tanned skin. The Venus Epileve is a portable and versatile tabletop device that offers two modes of operation (SLIDE and PULSE) and a real-time cooling system aimed at ensuring patient safety and comfort. The Venus Epileve is integrated with Internet of Things (IoT) technology that collects technical information to help providers enhance business operations and improve treatment efficiency.
“The receipt of CE Mark and Health Canada Authorization for our new laser hair removal solution, the Venus Epileve, represents another example of Venus Concept’s ability to introduce new and innovative solutions designed specifically for the non-traditional aesthetics market,” said Domenic Serafino, Chief Executive Officer and Director of Venus Concept Inc. “Building on the success of the Venus Velocity, we designed the Venus Epileve as a cost-effective laser hair removal solution for customers outside of the medical aesthetics market. We are preparing for a limited launch of the Venus Epileve in Europe and Canada beginning in the second quarter of 2020 with the full launch targeted for the second half of 2020. We look forward to the commercial expansion of Venus Epileve in these markets contributing to our solid growth profile next year and we expect our expanded portfolio of laser hair removal solutions will help us further penetrate the $1.4 billion global hair removal market1 in the years to come.”