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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 K171835
Device Name Irradiation Aesthetic Device
Applicant
Chongqing Peninsula Medical Technology Co., Ltd.
No.2-4, 2F BLK1, Biological and Biochemical Park
70-1 & 70-2# Ke Yuan 4 RD
Jiulongpo District,  CN 404100
Applicant Contact Zhang Sudi
Correspondent
Guangzhou GLOMED Biological Technology Co., Ltd.
Suite 306, Kecheng Mansion
No.121 Science Road, Guangzhou Science Park
Guangzhou,  CN 51006
Correspondent Contact Cassie Lee
Regulation Number890.5500
Classification Product Code
OAP  
Date Received06/20/2017
Decision Date 01/30/2018
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
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