510(k) K223909

R2GATE Lite TM by Megagen Implant Co., Ltd. — Product Code LLZ

K223909 is an FDA 510(k) premarket notification submitted by Megagen Implant Co., Ltd. for the device "R2GATE Lite TM". The FDA issued a decision of Substantially Equivalent on October 20, 2023. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Megagen Implant Co., Ltd. has at least 10 other 510(k) clearances on record.