510(k) K223440

Device

Plasma Pen (Plasma MD); Plasma Pen (Plasma +)

Applicant

Plasma Concepts

510(k) number

K223440

Product code

QVJ

Decision

Substantially Equivalent (SESE)

Decision date

2023-03-02

Date received

2022-11-14

Regulation

878.4400

Classification name

Low Power Electrosurgical Devices For Skin Lesion Destruction

Medical specialty

General, Plastic Surgery

Review panel

General, Plastic Surgery

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No