FDA 510(k) Application Details - K153634

Device Classification Name	More FDA Info for this Device
510(K) Number	K153634
Device Name	Wireless Earlens Light Driven Hearing Aid
Applicant	EARLENS CORPORATION 4045-A CAMPBELL AVENUE MENLO PARK, CA 94025 US Other 510(k) Applications for this Company
Contact	Deborah Arthur Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PLK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/18/2015
Decision Date	04/06/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review