QVJ

4 FDA 510(k) clearances · Product code

FDA profile

Official device name

Low Power Electrosurgical Devices For Skin Lesion Destruction

Device class

Class II (moderate risk)

Regulation

21 CFR 878.4400

Medical specialty

General, Plastic Surgery

FDA 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

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