FDA 510(k) Application Details - K243811

Device Classification Name	More FDA Info for this Device
510(K) Number	K243811
Device Name	Erchonia Zerona« VZ8
Applicant	Erchonia Corporation 112 Southchase Blvd Fountain Inn, SC 29644 US Other 510(k) Applications for this Company
Contact	Travis Sammons 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	12/11/2024
Decision Date	01/10/2025
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	Y
Expedited Review