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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 K192552
Device Name Irradiation Cosmetic 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.
2231, Building 1, Rui Feng Center, Kaichuang Road,
Huangpu District
Guangzhou,  CN 51006
Correspondent Contact Cassie Lee
Regulation Number890.5500
Classification Product Code
OAP  
Date Received09/17/2019
Decision Date 04/17/2020
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
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