FDA 510(k) Application Details - K231238

Device Classification Name	More FDA Info for this Device
510(K) Number	K231238
Device Name	Ultravision2Ö System
Applicant	Alesi Surgical Ltd 128 Blye Hill Landing Newbury, NH 03255 US Other 510(k) Applications for this Company
Contact	Michele Lucey Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PQM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/28/2023
Decision Date	10/31/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review