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Low Power Electrosurgical Devices For Skin Lesion Destruction

FDA product code QVJ · 4 cleared devices

Class 2 General, Plastic Surgery
Regulation
21 CFR 878.4400
Review panel
SU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2023-03-02 – 2024-02-20

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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