Low Power Electrosurgical Devices For Skin Lesion Destruction

QVJ · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4400

Classification

FDA Product Code: QVJ
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 878.4400
Review panel: SU
Medical specialty: General, Plastic Surgery
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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

Market data

Cleared 510(k) submissions: 4
Registered establishments: 4

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown