510(k) K220198

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

K220198 is an FDA 510(k) premarket notification submitted by Ya-Man, Ltd. for the device "Medi Lift PLUS". The FDA issued a decision of Substantially Equivalent on June 28, 2023. 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
June 28, 2023
Date Received
January 24, 2022
Clearance Type
Traditional
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