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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Low Power Electrosurgical Devices For Skin Lesion Destruction
510(k) Number K233760
Device Name Mjolnir Pro. (Multi–electrode plasma)
Applicant
Shenzhen Leaflife Technology Co., Ltd
4F, Bldg. C, JMD Industrial Park, No.39 Qingfeng Blvd.,
Baolong Industrial Area, Longgang District
Shenzhen,  CN 518116
Applicant Contact Qiang Cheng
Correspondent
Shenzhen Leaflife Technology Co., Ltd
4F, Bldg. C, JMD Industrial Park, No.39 Qingfeng Blvd.,
Baolong Industrial Area, Longgang District
Shenzhen,  CN 518116
Correspondent Contact Qiang Cheng
Regulation Number878.4400
Classification Product Code
QVJ  
Date Received11/24/2023
Decision Date 02/20/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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