Bare: 808

Bare: 808 is a medical device manufactured by Luvo Medical Technologies, Inc.. It received FDA 510(k) clearance on 2020-03-10 under approval number K193446. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.