510(k) K240485

LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use) by Huizhou Foryou Medical Devices Co., Ltd. — Product Code FRO

K240485 is an FDA 510(k) premarket notification submitted by Huizhou Foryou Medical Devices Co., Ltd. for the device "LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use)". The FDA issued a decision of Substantially Equivalent on October 7, 2024. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Huizhou Foryou Medical Devices Co., Ltd. has at least 10 other 510(k) clearances on record.