SkinRex has been issued a FDA warning letter, concerning its marketing of Cavi-Lipo without approval or clearance.
Korean cosmetic medical device company SkinRex Co. is in hot water with the FDA after the federal watchdog agency issued a warning letter over the marketing of its Cavi-Lipo device.
Seoul-based Skinrex is focused on skincare and weight issues. The company, founded in 2002, is led by Se-Yeong Choi and markets 3 products.
The Cavi-Lipo is an ultrasound cavitation system that uses ultrasound waves to dissolve cellulite and treat adipose areas. The device was launched in Japan in 2008 and won CE Mark approval in Europe in 2010, according to the SkinRex website.