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

FDA 510(k) K223440 · Plasma Concepts

Substantially Equivalent

510(k) numberK223440

Submission

Device name
Plasma Pen (Plasma MD); Plasma Pen (Plasma +)
Applicant
Plasma Concepts
Woburn, MA, US
Received
November 14, 2022
Decision date
March 2, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
QVJ – Low Power Electrosurgical Devices For Skin Lesion Destruction
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4400
Specialty
General, Plastic Surgery

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

Other 510(k)s with product code QVJ

510(k)DeviceApplicantDecision
K233760Mjolnir Pro. (Multi–electrode plasma)QVJ · Traditional Shenzhen Leaflife Technology Co., Ltd.02/20/2024SE
K220493Plaxpot Multi PlasmaQVJ · Traditional Gcs Co. Limited10/27/2023SE
K213247JETT PLASMA Medical IIQVJ · Traditional Compex, Spol, S.R.O.03/14/2023SE

Questions and answers

When was Plasma Pen (Plasma MD); Plasma Pen (Plasma +) cleared by the FDA?

Plasma Pen (Plasma MD); Plasma Pen (Plasma +) (K223440) received a 510(k) decision of Substantially Equivalent on March 2, 2023, 108 days after the submission was received.

What is the product code of K223440?

The FDA product code is QVJ – Low Power Electrosurgical Devices For Skin Lesion Destruction, a Class II (moderate risk) device regulated under 21 CFR 878.4400.