Clearance Summary
Medi Lift Essential Eye Mask received FDA 510(k) clearance under submission number K250618, sponsored by Ya-Man, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2025-10-29.
- Submission: K250618
- Applicant / Sponsor: Ya-Man, Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2025-10-29
Classification & Regulation
This clearance is catalogued under FDA product code NFO and 21 CFR 882.5890, within the Neurology review panel as a Class II device.