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

Mjolnir Pro.

Name: Mjolnir Pro.
Brand: Mjolnir Pro.

Catalogue number LE-EPSMC, listed by Shenzhen Leaflife Technology Co., Ltd., China, under Low Power Electrosurgical Devices For Skin Lesion Destruction. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

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 Mjolnir Pro.
Listed by	Shenzhen Leaflife Technology Co., Ltd., China
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, Exporter
Record published	2024-09-09

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Label carries	serial number

Catalogue Numbers

Catalogue numbers for Mjolnir Pro.
Catalogue number	Size	Status
LE-EPSMC		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
Plaxpot Multi Plasma	GCS Co., Ltd.	1
Jett	Compex, spol. s r.o.	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K233760	2024-02-20

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.