美國450 二極雷射設備

US 450 Diode Laser Equipment is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Globalipl Development Co., Ltd.. It received FDA 510(k) clearance on 2022-12-09 under 510(k) number K222916. 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.