FDA.reportPublic FDA data

510(k) K213247

Device
JETT PLASMA Medical II
Applicant
Compex, Spol, S.R.O.
510(k) number
K213247
Product code
QVJ
Decision
Substantially Equivalent (SESE)
Decision date
2023-03-14
Date received
2021-09-30
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
Statement
Third party reviewed
No

Applicant Contact#

Contact
Eva Hamplova
Address
Palackeho Trida 924/105 Brno CZ 61200 61200

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K220493Plaxpot Multi PlasmaGcs Co. Limited2023-10-27
K223440Plasma Pen (Plasma MD); Plasma Pen (Plasma +)Plasma Concepts2023-03-02