FDA 510(k) Application Details - K192544

Device Classification Name	More FDA Info for this Device
510(K) Number	K192544
Device Name	Erchonia Emerald
Applicant	Erchonia Corporation 650 Atlantis Road Melbourne, FL 32904 US Other 510(k) Applications for this Company
Contact	Steven Shanks Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OLI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/16/2019
Decision Date	01/13/2020
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