FDAnews Device Daily Bulletin

A medical device alleged to melt cellulite should be removed from the market immediately because it poses a significant safety risk and was never cleared by the FDA, patient advocacy group Public Citizen says in a July 18 letter to the FDA. According to the group, RevecoMED petitioned the FDA for 510(k) approval of the LipoTron device in 2007 and 2009, but was denied clearance both times due to insufficient information in the company’s 510(k) submission. Despite being turned down, LipoTron remained on the market, the letter states, adding the product poses a significant burn risk.
Devices & Diagnostics Letter