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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 K261407
Device Name XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422, XPRE434, XPRE451, XPRE455, XPRE457, XPRE448, XPRE335, XPRE350, XPRE420, XPRE436, XPRE339, XPRE445)
Applicant
Dongguan Miqiang Technology Co., Ltd.
# 6, Gongye 1st Rd., Hengjiangsha Village, Changping Town
Dongguan,  CN 523573
Applicant Contact Charles (Chengyu) Shen
Correspondent
Manton Business and Technology Services
37 Winding Ridge
Oakland,  NJ  07436
Correspondent Contact Charles (Chengyu) Shen
Regulation Number878.4810
Classification Product Code
OHS  
Subsequent Product Code
OLP  
Date Received04/29/2026
Decision Date 07/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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