FDA 510(k) Application Details - K240868

Device Classification Name	More FDA Info for this Device
510(K) Number	K240868
Device Name	Ultravision2Ö IonPencil
Applicant	Alesi Surgical Limited Cardiff Medicentre, Heath Park, Cardiff, CF14 4UJ Cardiff GB Other 510(k) Applications for this Company
Contact	Pravin Patel 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	03/29/2024
Decision Date	08/12/2024
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