510(k) K171821

2 Face / Face Evolution by Heat IN A Click — Product Code NFO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 2018
Date Received
June 19, 2017
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