What is FDA product code QVJ?

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

General & Plastic Surgery › SurgicalLow Power Electrosurgical Devices For Skin Lesion Destruction

Plaxpot Multi Plasma

Name: Plaxpot Multi Plasma
Brand: Plaxpot Multi Plasma

The Plaxpot Multi Plasma removes and destroys skin lesions and coagulates tissue using a plasma arc. Its handheld body contains a battery and electrode tip, with a separate charging cradle…

Registry build 21.09.26

The Plaxpot Multi Plasma removes and destroys skin lesions and coagulates tissue using a plasma arc. Its handheld body contains a battery and electrode tip, with a separate charging cradle and power adapter.

After the operator selects a mode and presses the shot button, the device releases a high-voltage alternating-current pulse. This ionises the air in the gap between the tip and skin to form the plasma arc, allowing treatment without direct electrode contact with tissue.

Power and Activation

The internal battery supplies power during use. Treatment output follows the selected setting and is activated by the shot control, while the cradle and adapter recharge the device.

1manufacturer

1catalogue number

1510(k) clearance

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code QVJ
Manufacturer	City	Province	Registered as	Device types
Shenzhen Leaflife Technology Co., Ltd.	Shenzhen	Guangdong	Manufacturer	5

Record

Regulatory record for Plaxpot Multi Plasma
Listed by	GCS Co., Ltd., South Korea
FDA product code	QVJ
Device type	Low Power Electrosurgical Devices For Skin Lesion Destruction
Device class	Class 2
Regulation	21 CFR 878.4400
Establishment	Manufacturer
510(k)	K220493
Record published	2024-11-14

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Plaxpot Multi Plasma
Catalogue number	Size	Status
GPX-2000		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
PlasmaMD	Med Pen Concepts LLC	2
Plasma+	Med Pen Concepts LLC	2
Mjolnir Pro.	Shenzhen Leaflife Technology Co., Ltd.	1
Jett	Compex, spol. s r.o.	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K220493	2023-10-27

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.