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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 K261601
Device Name LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)
Applicant
Shenzhen Chuangtong Yigou Technology Co., Ltd.
Rm. 2218, Rongchuang Zhihui Bldg. A
Shangfen Community, Minzhi St., Longhua District
Shenzhen,  CN
Applicant Contact Kingway Hong
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center, # 3101-90, Qia
Shenzhen,  CN 518052
Correspondent Contact Candice Qiu
Regulation Number878.4810
Classification Product Code
OHS  
Subsequent Product Codes
ILY   OLP  
Date Received05/14/2026
Decision Date 08/07/2026
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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