510(k) K211123

LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel by Huizhou Foryou Medical Devices Co., Ltd. — Product Code FRO

K211123 is an FDA 510(k) premarket notification submitted by Huizhou Foryou Medical Devices Co., Ltd. for the device "LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel". The FDA issued a decision of Substantially Equivalent on April 22, 2022. 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.