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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 K213789
Device Name Intelligence LaserComb
Yibin Yingtong Intelligent Technology Co.,Ltd.
3F, Building 1, Area A, Intelligent Terminal Industrial Park
Yibin Economic Development Zone
Yibin,  CN 644000
Applicant Contact Pengcheng Pan
SGS-CSTC Standards Technical Services Co., Ltd.
198 Kezhu Road, Scientech Park Guangzhou Economic &
Technology Development District
Guangzhou,  CN 510000
Correspondent Contact Iris Fung
Regulation Number890.5500
Classification Product Code
Date Received12/06/2021
Decision Date 06/24/2022
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