FDA Product Code QVJ: Low Power Electrosurgical Devices For Skin Lesion Destruction
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
Leading manufacturers include Compex, Spol, S.R.O., Gcs Co. Limited and Plasma Concepts.
FDA 510(k) Cleared Low Power Electrosurgical Devices For Skin Lesion Destruction Devices (Product Code QVJ)
About Product Code QVJ - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code QVJ since 2023, with 4 receiving FDA clearance (average review time: 335 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 4 in the prior period.
QVJ devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →