Venus Concept Announces FDA 510(k) Clearance for Venus Viva MD

The device allows medical aesthetics clinicians to treat a wider range of skin conditions. Photo credit: Venus Concept

Venus Concept Inc. announced that it has received FDA 510(k) clearance to market and sell Venus Viva MD. Venus Viva MD is a non-invasive device intended to be used by aesthetic-related physicians or dermatologists. It is a portable and versatile tabletop device that enables a wide range of treatments with two applicators. When used with the new Viva MD applicator, the Venus Viva MD device is intended for use in dermatological procedures requiring ablation and resurfacing of the skin including conditions such as acne scars, dyschromia, striae, and enlarged pores. “We are pleased to announce FDA 510(k) clearance for our Venus Viva MD device and are preparing to begin a limited launch by the end of the third quarter,” says Domenic Serafino, CEO and director of Venus concept. “The Venus Viva MD is a product we designed specifically for dermatologists and plastic surgeons in the U.S., which leverages our strong skin rejuvenation offerings in Venus Viva and Venus Versa, but offers differentiated features that allow clinicians in the traditional medical aesthetics community to treat a wider range of skin conditions. Importantly, this new product introduction is another example of our continued focus on introducing new and innovative technology solutions each year, while also identifying ways to enhance the contributions to our overall growth from the sale of utilization-based handpieces over time. We expect the U.S. commercialization of the Venus Viva MD to contribute to the company’s long-term growth profile and believe our expanded portfolio of skin rejuvenation solutions will help us further penetrate the $3.4 billion global energy-based aesthetic device market1 in the years to come.”

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