FDA 510(k) Application Details - K200803

Device Classification Name	Stimulator, Transcutaneous Electrical, Aesthetic Purposes   More FDA Info for this Device
510(K) Number	K200803
Device Name	Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Applicant	FOREO, Inc. 1525 E. Pama Lane Las Vegas, NV 89119 US Other 510(k) Applications for this Company
Contact	Laura HoShue Other 510(k) Applications for this Contact
Regulation Number	882.5890   More FDA Info for this Regulation Number
Classification Product Code	NFO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/27/2020
Decision Date	07/31/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review