1927nm 鈷激光系統 (PZ-DJG75-01, PZ-DJG75-02)

1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02) is the device name listed in this FDA 510(k) record. The listed applicant is Zhengzhou PZ Laser Slim Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-10-23 under 510(k) number K252732. 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.