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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light Based Over The Counter Wrinkle Reduction
510(k) Number K244020
Device Name Wrinkle Treatment Device (JM1, JM2B)
Applicant
Shenzhen Qianyu Technology Co., Ltd.
Rm. 601, Han’S Technology Center. #9988, Shennan Ave.,
Maling Community, Yuehai St., Nanshan District
Shenzhen,  CN 518000
Applicant Contact Guoyang Li
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center, # 3101-90, Qia
Shenzhen,  CN 518052
Correspondent Contact Riley Chen
Regulation Number878.4810
Classification Product Code
OHS  
Date Received12/27/2024
Decision Date 05/01/2025
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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