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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 K190467
Device Name iHelmet Hair Growth System
Slinph Technologies Co., LTD
Room 211, Building B, 1970 Cultural and Creative Industrial
Park, Mini Street
Shenzhen,  CN 518107
Applicant Contact Zou Jian
SK Medical Device International Corp.
Suite 52, Floor 16, No. 119 Xing Guang Ying Jing, Shui Ying
Guangzhou,  CN 51006
Correspondent Contact S K
Regulation Number890.5500
Classification Product Code
Date Received02/26/2019
Decision Date 12/26/2019
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