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510(k) K220493

Device
Plaxpot Multi Plasma
Applicant
Gcs Co. Limited
510(k) number
K220493
Product code
QVJ
Decision
Substantially Equivalent (SESE)
Decision date
2023-10-27
Date received
2022-02-22
Regulation
878.4400
Classification name
Low Power Electrosurgical Devices For Skin Lesion Destruction
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Su Kyung Park
Address
#1008, 555, Dunchon-Daero, Jungwon-Gu, Seongnam-Si, Gyeonggi-Do Seongnam KR 13215 13215

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QVJ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.2024-02-20
K213247JETT PLASMA Medical IICompex, Spol, S.R.O.2023-03-14
K223440Plasma Pen (Plasma MD); Plasma Pen (Plasma +)Plasma Concepts2023-03-02