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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 K232356
Device Name Laser Cap, Model: Hat-01
Applicant
Hubei Yjt Technology Co.,Ltd
Rm.1-4 ,8f,Block7,Guannan Fuxing Pharmaceutical Park,#62
Optical Valley Ave.
Wuhan,  CN 430000
Applicant Contact Jiali Xie
Correspondent
Shenzhen Tacro Medical Technology Services Co., Ltd.
Suite 405, Bldg. A Nanfeng, #4093 Liuxian Blvd., Nanshan
Dist.
Shenzhen,  CN 510000
Correspondent Contact Gamma Zhang
Regulation Number890.5500
Classification Product Code
OAP  
Date Received08/07/2023
Decision Date 10/24/2023
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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