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www.fdanews.com/articles/206293-venus-concept-gets-fdas-510k-clearance-for-its-blissmax-device

Venus Concept Gets FDA’s 510(k) Clearance for Its BlissMAX Device

January 25, 2022

Toronto-based Venus Concept has received 510(k) clearance from the FDA for its Venus BlissMAX device that combines laser fat reduction, cellulite reduction and muscle conditioning.

The noninvasive device uses laser technology to reduce unwanted fat in the abdomen and flanks in individuals with a body mass index of of 30 or less, according to the company. It also uses radio frequency and pulsed electromagnetic fields to reduce the appearance of cellulite and to stimulate healthy muscles.

The company is planning a limited commercial launch in the U.S. by the end of the first quarter of 2022.

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