510(k) K233525

MF SC Facial Toning System by Micro Current Technology, Inc. — Product Code NFO

K233525 is an FDA 510(k) premarket notification submitted by Micro Current Technology, Inc. for the device "MF SC Facial Toning System". The FDA issued a decision of Substantially Equivalent on November 24, 2023. The device falls under product code NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes), a Class II device regulated under 21 CFR 882.5890. Micro Current Technology, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 2023
Date Received
November 1, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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