FDA 510(k) Application Details - K161089

Device Classification Name	Light Based Over-The-Counter Hair Removal   More FDA Info for this Device
510(K) Number	K161089
Device Name	Light Based Over-The-Counter Hair Removal
Applicant	EL GLOBAL TRADE LTD 8 TZORAN ST, P.O. BOX 8242 NETANYA 4250604 IL Other 510(k) Applications for this Company
Contact	YAEL LIEBES-PEER Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	OHT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/18/2016
Decision Date	07/08/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review