FDA 510(k) Application Details - K181568

Device Classification Name	Light Based Over-The-Counter Hair Removal   More FDA Info for this Device
510(K) Number	K181568
Device Name	Light Based Over-The-Counter Hair Removal
Applicant	Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt 4th Floor of Building #1, No.228, Jiaosong Road Taiwanese Investment Zone Zhangzhou CN Other 510(k) Applications for this Company
Contact	Bruce Wu 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	06/14/2018
Decision Date	09/11/2018
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