DeviceClearance

Product code QVJ— General, Plastic Surgery

JETT PLASMA Medical II

Classification name
Low Power Electrosurgical Devices For Skin Lesion Destruction
Device class
Class 2
Regulation
21 CFR 878.4400
Advisory panel
General, Plastic Surgery
Total cleared
4
First cleared
Most recent

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”

— U.S. Food and Drug Administration, device classification record for product code QVJ under 21 CFR 878.4400, via openFDA

Market context for product code QVJ

FDA has cleared 4 devices under product code QVJ between 2023 and 2024, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QVJ

Recent clearances under product code QVJ

Data sourced from openFDA. This site is unofficial and independent of the FDA.