QVJ

Low Power Electrosurgical Devices For Skin Lesion Destruction

Product code
QVJ
Device name
Low Power Electrosurgical Devices For Skin Lesion Destruction
Device class
Class 2
21 CFR
21 CFR 878.4400
Medical specialty
General, Plastic Surgery
Marketing pathway
510(K)
510(k) clearances (last 3 years)
4

FDA classification definition

For the removal and destruction of skin lesions in general dermatological procedures, also referred to as Plasma Pen Devices, which generates electrical arc in the ambient air between an electrical probe tip and the skin and cause intended tissue damage for the removal and destruction of skin lesions

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2024-02-20.

NumberDecision dateApplicantDevice nameSummary
K2337602024-02-20Shenzhen Leaflife Technology Co., Ltd.Mjolnir Pro. (Multi–electrode plasma)PDF
K2204932023-10-27Gcs Co. LimitedPlaxpot Multi PlasmaPDF

2 summaries are archived here for direct download.

Official FDA classification page: QVJ
Classification and pathway per current FDA publications. Data from openFDA (CC0).