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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 K263313
Device Name Red Light Therapy Hair Growth Cap (RB-009, RB-011, RB-012, RB-088, RB-089, RB-092)
Applicant
Shenzhen Rainbow Technology Co., Ltd.
3th Floor, # 2, Dongwangyang Industry
Huangtian Community, Hangcheng St., Bao'An District
Shenzhen,  CN 518000
Applicant Contact Terry Liu
Correspondent
Share Info (Guangzhou) Medical Consultant , Ltd.
# 1919-1920, Bldg. D3, Minjie Plz., Shuixi Rd.
Huangpu District
Guangzhou,  CN
Correspondent Contact Cassie Lee
Regulation Number890.5500
Classification Product Code
OAP  
Date Received09/21/2026
Decision Date 10/28/2026
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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