510(k) K250618

Medi Lift Essential Eye Mask by Ya-Man, Ltd. — Product Code NFO

K250618 is an FDA 510(k) premarket notification submitted by Ya-Man, Ltd. for the device "Medi Lift Essential Eye Mask". The FDA issued a decision of Substantially Equivalent on October 29, 2025. The device falls under product code NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes), a Class II device regulated under 21 CFR 882.5890. Ya-Man, Ltd. has at least 5 other 510(k) clearances on record.