510(k) K162106

Micro-current Wrinkle Reduction Facial service, model EP-400 by Li-Tek Electronic Technology Corporation — Product Code NFO

K162106 is an FDA 510(k) premarket notification submitted by Li-Tek Electronic Technology Corporation for the device "Micro-current Wrinkle Reduction Facial service, model EP-400". The FDA issued a decision of Substantially Equivalent on Feb 3, 2017. The device falls under product code NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes), a Class II device regulated under 21 CFR 882.5890. Li-Tek Electronic Technology Corporation has 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 3, 2017
Date Received
Jul 29, 2016
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
510(k)