FDA 510(k) Application Details - K243716

Device Classification Name	More FDA Info for this Device
510(K) Number	K243716
Device Name	Zionic Pro Max (Radiofrequency)
Applicant	TermoSalud S.L. Ataulfo Friera Tarfe 8 Gijon 33211 ES Other 510(k) Applications for this Company
Contact	Cristina Cifuentes 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	12/02/2024
Decision Date	05/28/2025
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