510(k) K242856

LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer) by Huizhou Foryou Medical Devices Co., Ltd. — Product Code FRO

K242856 is an FDA 510(k) premarket notification submitted by Huizhou Foryou Medical Devices Co., Ltd. for the device "LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer)". The FDA issued a decision of Substantially Equivalent on November 13, 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.