FDA 510(k) Application Details - K230755

Device Classification Name	More FDA Info for this Device
510(K) Number	K230755
Device Name	NuEra Tight RF Model OptiStream
Applicant	BIOS s.r.l. Via Guido Rossa 10/12 Vimodrone 20055 IT Other 510(k) Applications for this Company
Contact	Martina De Iturbe 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	03/17/2023
Decision Date	10/30/2023
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