510(k) K250642

LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.) by Huizhou Foryou Medical Devices Co., Ltd. — Product Code FRO

K250642 is an FDA 510(k) premarket notification submitted by Huizhou Foryou Medical Devices Co., Ltd. for the device "LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)". The FDA issued a decision of Substantially Equivalent on November 19, 2025. 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.