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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name light based over the counter wrinkle reduction
510(k) Number K200983
Device Name Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine
Applicant
Ningbo Hesi Electric Co., Ltd
No.818-23-156 Qiming Rd, Yinzhou, Ningbo City Zhejiistrict,
Ningbo, Zhejiang,
Ningbo,  CN 315000
Applicant Contact Ma LuLu
Correspondent
Guangzhou GLOOMED Biological Technology Co., Ltd.
2231, Building 1, Rui Feng Center, Kaichuang Road,
Huangpu District, Guangzh
Guangzhou,  CN 511495
Correspondent Contact Cassie Lee
Regulation Number878.4810
Classification Product Code
OHS  
Subsequent Product Codes
ILY   OLP  
Date Received04/14/2020
Decision Date 07/14/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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