JOULE 1064nm System and Accessories

JOULE 1064nm System and Accessories is a medical device manufactured by Sciton, Inc. It received FDA 510(k) clearance on 2025-12-19 under approval number K251077. 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.