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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 K202390
Device Name Aduro Light Beauty Mask
Applicant
Shenzhen Kaiyan Medical CO , Ltd.
40a Fuxin Rd. Fuyong Subdistrict Baoan District,
Shenzhen,  CN 518101
Applicant Contact Alain Dijkstra
Correspondent
Guangzhou GLOMED Biological Technology Co., Ltd.
2231, Bldg. 1, Rui Feng Center, Kaichuang Rd.
Huangpu District
Guangzhou,  CN 510006
Correspondent Contact Cassie Lee
Regulation Number878.4810
Classification Product Code
OHS  
Subsequent Product Codes
ILY   OLP  
Date Received08/21/2020
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
Predetermined Change
Control Plan Authorized		 No
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