Low Power Electrosurgical Devices for Skin Lesion Destruction

What Is It?

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

How Is QVJ Classified?

Low Power Electrosurgical Devices For Skin Lesion Destruction is FDA product code QVJ, Class 2, 21 CFR 878.4400.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 1 clearance under this code; the FDA took 88 days from receipt to decision.