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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
Slinph Technologies Co., Ltd
Room 211, Building B,
1970 Cultural and Creative Industrial Park, Minzhi Street
Longhua, Shenzhen,  CN 518110
Applicant Contact Jian Zou
Guangzhou GLOMED Biological Technology Co., Ltd.
2231, Building 1, Rui Feng Center, Kaichung Road,
Huangpu District
Guangzhou,  CN 51006
Correspondent Contact Cassie Lee
Regulation Number890.5500
Classification Product Code
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