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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name laser, comb, hair
510(k) Number K210169
Device Name Hair Growth Device
Dongguan Lescolton Intelligent Electrical Appliance Co., Ltd
401, Building 1, #3, Xinxing 3rd Road, jiaoshe, Dongkeng
Dongguan,  CN 523586
Applicant Contact Liu Jianwen
Guangzhou Junyi Information Technology Co., Ltd.
Room 304, Building A, No. 62 Nanyun 2nd Road, Science Town
Huangpu District, Guangzhou City,  CN 510663
Correspondent Contact Jinghua Zhou
Regulation Number890.5500
Classification Product Code
Date Received01/22/2021
Decision Date 04/16/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No