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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 K162782
Device Name iHelmet Hair Growth System
Applicant
Slinph Technologies Co., Ltd.
Rm. 211, Bldg. B, 1970 Cultural And Creative Park,
Mini St.
Shenzhen,  CN 518107
Applicant Contact Zou Jian
Correspondent
Guangzhou Glomed Biological Technology Co., Ltd.
Suite 306, Kecheng Mansion, # 121 Science Rd., Guangzhou
Science Park
Guangzhou,  CN 510663
Correspondent Contact Cecilia Ceng
Regulation Number890.5500
Classification Product Code
OAP  
Date Received10/03/2016
Decision Date 04/04/2017
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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