FDA 510(k) Application Details - K153164

Device Classification Name	More FDA Info for this Device
510(K) Number	K153164
Device Name	LunulaLaser
Applicant	ERCHONIA MEDICAL, INC. 2021 COMMERCE DR. MCKINNEY, TX 75069 US Other 510(k) Applications for this Company
Contact	STEVE SHANKS Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/02/2015
Decision Date	06/03/2016
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