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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 K222477
Device Name Hair Growth Device
Applicant
Dongguan Lescolton Medical Equipment Co., Ltd.
402, Bldg. 1, #3, Xinxing 3rd Rd., Jiaoshe, Dongkeng
Town
Dongguan,  CN 523443
Applicant Contact Qixiang Liu
Correspondent
Guangzhou Junyi Information Technology Co., Ltd.
Rm. 304, Bldg. A, # 62 Nanyun 2nd Rd., Science Town
Huangpu District, Guangzhou City,  CN 510663
Correspondent Contact Shanfeng Jiang
Regulation Number890.5500
Classification Product Code
OAP  
Date Received08/16/2022
Decision Date 11/18/2022
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
Predetermined Change
Control Plan Authorized		 No
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