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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 K253135
Device Name LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1, HGMZ-2W-G2V1,MRD-GJXJ-G1V1.)
Applicant
Dongguan Yijiaming Technology Co., Ltd.
Rm. 301, Bldg. 1, # 1, Bikengdong 1st Lane,
Dongguan,  CN 523825
Applicant Contact Qiang Huang
Correspondent
Huide Medical Technology Service Group Co., Ltd.
Rm. 703, Bldg. 16, S. Bank Plaza
Exhibition Bay, Zhancheng Community, Fuhai St., Bao'An Dist
Shenzhen,  CN 518103
Correspondent Contact Tulin Lin
Regulation Number878.4810
Classification Product Code
OHS  
Date Received09/25/2025
Decision Date 12/23/2025
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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