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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 K213447
Device Name LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210.
Shenzhen CosBeauty Technology Co., Ltd.
UnitA-3F, Qiao De Industrial Park,
Tian Liao Guang Ming District
Shenzhen,  CN 518000
Applicant Contact Ares Zou
Feiying Drug & Medical Consulting Technical Service Group
Rm 2401 Zhenye International Business Center, No. 3101-90
Qianhai Road,
Shenzhen,  CN 518052
Correspondent Contact Tracy Che
Regulation Number890.5500
Classification Product Code
Date Received10/25/2021
Decision Date 01/19/2022
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