FDA 510(k) Application Details - K202247

Device Classification Name	More FDA Info for this Device
510(K) Number	K202247
Device Name	V30 system, V20 system, V10 system, V-VR Hand piece
Applicant	Viora Ltd. 6 Hagavish Street Netanya 4250706 IL Other 510(k) Applications for this Company
Contact	Simona F Krant 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	08/10/2020
Decision Date	12/09/2020
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