FDA 510(k) Application Details - K162450

Device Classification Name	Over-The-Counter Powered Light Based Laser For Acne   More FDA Info for this Device
510(K) Number	K162450
Device Name	Over-The-Counter Powered Light Based Laser For Acne
Applicant	FOREO INC. 1525 Pama Lane, Suite 200 Las Vegas, NV 89119 US Other 510(k) Applications for this Company
Contact	Davor Soldo Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	OLP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/01/2016
Decision Date	11/30/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review