510(k) K244048

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

K244048 is an FDA 510(k) premarket notification submitted by Ya-Man, Ltd. for the device "Medi Lift Mask". The FDA issued a decision of Substantially Equivalent on January 16, 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.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 2025
Date Received
December 31, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type