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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 K243555
Device Name LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)
Applicant
Shenzhen Eyco Technology Co., Ltd.
2 /F, Bldg. 1, Jiashitai Science Park, 164# Fengtang Ave.
Fuhai St., Baoan District, Shenzhen 518103, China
Guangdong,  CN 518103
Applicant Contact Ding Martin
Correspondent
Share Info (Guangzhou) Medical Consultant , Ltd.
# 1919-1920, Bldg. D3, Minjie Plaza, Shuixi Rd.
Huangpu District, Guangzhou, China
Guangdong,  CN 510530
Correspondent Contact Lee Cassie
Regulation Number878.4810
Classification Product Code
OLP  
Subsequent Product Code
OHS  
Date Received11/18/2024
Decision Date 02/05/2025
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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