FDA 510(k) Application Details - K220493

Device Classification Name	More FDA Info for this Device
510(K) Number	K220493
Device Name	Plaxpot Multi Plasma
Applicant	GCS Co. Limited #1008, 555, Dunchon-daero, Jungwon-gu, Seongnam-si, Gyeonggi-do Seongnam 13215 KR Other 510(k) Applications for this Company
Contact	Su Kyung Park 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	02/22/2022
Decision Date	10/27/2023
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