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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 K262254
Device Name Hair Growth Comb (X-GC01)
Applicant
Guangdong Ashmore Health Technology Co., Ltd.
Rm. 709, 7th Floor, Bldg. 1, # 8 Changbao E. Rd., Huakou Com
Foshan,  CN 528305
Applicant Contact Guangchao Xu
Correspondent
Shenzhen HONESTY IS GOLD Medical Devices Co., Ltd.
Rm. 1204, Plz. Bldg., # 74, Baomin First Rd.
Jiaonan Community, Xin'An Subdistrict, Bao'An District
Shenzhen,  CN 518000
Correspondent Contact Youshan Gong
Regulation Number890.5500
Classification Product Code
OAP  
Subsequent Product Code
ISA  
Date Received07/02/2026
Decision Date 09/23/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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