510(k) K171821

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

K171821 is an FDA 510(k) premarket notification submitted by Heat IN A Click for the device "2 Face / Face Evolution". The FDA issued a decision of Substantially Equivalent on April 26, 2018. The device falls under product code NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes), a Class II device regulated under 21 CFR 882.5890. Heat IN A Click has at least 7 other 510(k) clearances on record.

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