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510(k) K233760

Device
Mjolnir Pro. (Multi?electrode plasma)
Applicant
Shenzhen Leaflife Technology Co., Ltd.
510(k) number
K233760
Product code
QVJ
Decision
Substantially Equivalent (SESE)
Decision date
2024-02-20
Date received
2023-11-24
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
Qiang Cheng
Address
4f, Bldg. C, Jmd Industrial Park, #39 Qingfeng Blvd., Baolong Industrial Area, Longgang District Shenzhen CN 518116 518116

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
K220493Plaxpot Multi PlasmaGcs Co. Limited2023-10-27
K213247JETT PLASMA Medical IICompex, Spol, S.R.O.2023-03-14
K223440Plasma Pen (Plasma MD); Plasma Pen (Plasma +)Plasma Concepts2023-03-02