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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Over-The-Counter Powered Light Based Laser For Acne
510(k) Number K242068
Device Name LED Light Therapy Mask (RT01)
Applicant
Ningbo Dechang Electrical Machinery Made Co.,Ltd
#18 Yongxing E. Rd. ,Dongjiao Industrial District
Yuyao,  CN 315400
Applicant Contact Yinling Liu
Correspondent
Shenzhen Reanny Medical Devices Management Consulting Co., Ltd.
Rm. 1509, Jingting Bldg., Dongzhou Community, Guangming St.,
Shenzhen,  CN 518107
Correspondent Contact Reanny Wang
Regulation Number878.4810
Classification Product Code
OLP  
Subsequent Product Code
OHS  
Date Received07/15/2024
Decision Date 04/04/2025
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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