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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 K202631
Device Name iHelmet Laser Comb
Applicant
Slinph Technologies Co., Ltd.
Rm. 211, Bldg. B,
1970 Cultural And Creative Industrial Park, Minzhi St.
Longhua, Shenzhen,  CN 518110
Applicant Contact Jian Zou
Correspondent
Guangzhou GLOMED Biological Technology Co., Ltd.
2231, Bldg. 1, Rui Feng Center, Kaichung Rd.,
Huangpu District
Guangzhou,  CN 51006
Correspondent Contact Cassie Lee
Regulation Number890.5500
Classification Product Code
OAP  
Date Received09/11/2020
Decision Date 12/08/2020
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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