FDA 510(k) Application Details - K223440

Device Classification Name	More FDA Info for this Device
510(K) Number	K223440
Device Name	Plasma Pen (Plasma MD); Plasma Pen (Plasma +)
Applicant	Plasma Concepts 800 W Cummings Park Woburn, MA 01801 US Other 510(k) Applications for this Company
Contact	Brendan Aarons Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QVJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/14/2022
Decision Date	03/02/2023
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