스플렌더 X (알렉스, 알렉스2, Nd:YAG, 알렉스+Nd:YAG)

Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) is the device name listed in this FDA 510(k) record. The listed applicant is Bios S.R.L.. It received FDA 510(k) clearance on 2024-12-30 under 510(k) number K243445. 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.