FDA 510(k) Application Details - K242553

Device Classification Name	More FDA Info for this Device
510(K) Number	K242553
Device Name	MIRARI« Cold Plasma System ( GV-M2-01)
Applicant	General Vibronics, Inc. 1615 East Warner Road Suite #4 Tempe, AZ 85284 US Other 510(k) Applications for this Company
Contact	Huan Truong Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PBX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/27/2024
Decision Date	11/21/2024
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