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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 K240360
Device Name Wrinkle Treatment Device (JM2)
Applicant
Shenzhen Qianyu Technology Co., Ltd.
Rm. 601, Han'S Technology Center, #9988, Shennan Ave.
Maling Community,Yuehai St., Nanshan District
Shenzhen City,  CN 518000
Applicant Contact Guoyang Li
Correspondent
Shenzhen Qianyu Technology Co., Ltd.
Rm. 601, Han'S Technology Center, #9988, Shennan Ave.
Maling Community,Yuehai St., Nanshan District
Shenzhen City,  CN 518000
Correspondent Contact Guoyang Li
Regulation Number878.4810
Classification Product Code
OHS  
Date Received02/06/2024
Decision Date 04/05/2024
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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