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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 K233114
Device Name LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)
Applicant
Shenzhen Idea Light Limited
3rd Floor, Block B, Shengdelan Industry Park,
Longhua District, Shenzhen City, Guangdong Province, China.
Shenzhen,  CN 518000
Applicant Contact Liu Nicole
Correspondent
Share Info (Guangzhou) Medical Consultant , Ltd.
# 1919-1920, Bldg. D3, Minjie Plaza, Shuixi Rd.,
Huangpu District, Guangzhou, China
Guangzhou,  CN
Correspondent Contact Lee Cassie
Regulation Number878.4810
Classification Product Code
OHS  
Subsequent Product Code
OLP  
Date Received09/27/2023
Decision Date 01/12/2024
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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