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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Vacuum, Radio Frequency Induced Heat
510(k) Number K250916
Device Name WinForth (LM-E470KA)
Applicant
Shenzhen Leaflife Technology Co., Ltd.
4f, Bldg.C ,Jmd Industrial Park, #39 Qingfeng Blvd.
Bao Long Industrial Area, Long Gang Dist.
Shenzhen,  CN 518116
Applicant Contact Cheng Qiang
Correspondent
Aestheticcert Compliance, LLC
11/F, Block A, Gaoke Innovation Centre, Guangqiao Rd.
Guangming District
Shenzhen,  CN 518000
Correspondent Contact Asher Zeng
Regulation Number878.4400
Classification Product Code
PBX  
Date Received03/27/2025
Decision Date 08/14/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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