meddevicedb.com FDA Device Reference

Mjolnir Pro. (Multi–electrode plasma)

K233760 Class II Traditional
Decision Date
2024-02-20
Sponsor / Applicant
Shenzhen Leaflife Technology Co., Ltd.

Technical Specification

510(k) Submission ID K233760
Product Code QVJ
Medical Specialty / Panel General, Plastic Surgery
Regulation Citation 21 CFR 878.4400
Decision Date 2024-02-20
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

Mjolnir Pro. (Multi–electrode plasma) received FDA 510(k) clearance under submission number K233760, sponsored by Shenzhen Leaflife Technology Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2024-02-20.

Classification & Regulation

This clearance is catalogued under FDA product code QVJ and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.