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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 K243978
Device Name LED Facial Mask
Applicant
Shenzhen Sunsred Technology Co.,Ltd
201, # 22, Shijing Rd., Fumin Community, Fucheng St.
Longhua District
Shenzhen,  CN
Applicant Contact Xiufeng Cai
Correspondent
Registrar Corp.
Rm. 502, Bldg. A, Phase I, Qianhai Economic And Trade Center
# 151 Free Trade W. St., Nanshan Sub-District,Qianhai
Shenzhen,  CN 518066
Correspondent Contact Jun Da Huang
Regulation Number878.4810
Classification Product Code
OHS  
Subsequent Product Codes
ILY   OLP  
Date Received12/23/2024
Decision Date 06/20/2025
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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