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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 K253231
Device Name Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500)
Applicant
Hubei Yjt Technology Co.,Ltd
Rm. 1-4, 8f, Block 7, Guannan Fuxing Pharmacel Park
#58, Optics Valley Ave., E. Lake High-Tech Development
Wuhan,  CN 430074
Applicant Contact Jiali Xie
Correspondent
Tacro
Bldg. 12, Jindi Xiandao Blue Valley, #2 Qiannong 1st Rd.
Xiaoshan Dist.
Hangzhou,  CN
Correspondent Contact Gamma Zhang
Regulation Number890.5500
Classification Product Code
OAP  
Date Received09/29/2025
Decision Date 06/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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