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

PlasmaMD · Low Power Electrosurgical Devices for Skin Lesion Destruction → General & Plastic Surgery

Name: PlasmaMD
Brand: PlasmaMD

1manufacturer

2catalogue numbers in this listing

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 PlasmaMD
Listed by	Med Pen Concepts LLC
FDA product code	QVJ
Device type	Low Power Electrosurgical Devices For Skin Lesion Destruction
Device class	Class 2
Regulation	21 CFR 878.4400
510(k)	K223440
Record published	2024-01-10

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date, serial number
Storage	Storage environment temperature 5 to 40 °C
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for PlasmaMD
Catalogue number	Size	Status
PlasmaMD		In distribution
PlasmaMD		In distribution

Same Product Code

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

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.

PlasmaMD

Who Else Makes It

Record

Specifications

Catalogue Numbers

Same Product Code

Where China Actually Supplies