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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 K253874
Device Name LED Therapy Light (COB1400, HP1800PRO)
Applicant
Shenzhen Hanhua Opto Co., Ltd.
Bldg. A, Yishida Baoyicheng Science And Technology Park
Dahe Community, Guanlan St., Longhua District
Shenzhen,  CN 518000
Applicant Contact Taishan Wu
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 Code
ILY  
Date Received12/04/2025
Decision Date 03/03/2026
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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