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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 K241857
Device Name LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)
Applicant
Dongguan Boyuan Intelligent Technology Co.,Ltd
Rm. 801, Bldg. 3, #3 Kuiqiao Rd., Puxin Lake, Tangxia
Dongguan,  CN 523719
Applicant Contact Le Li
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center, # 3101-90
Qianhai Rd.
Shenzhen,  CN 518052
Correspondent Contact Jilan Luo
Regulation Number878.4810
Classification Product Code
OHS  
Subsequent Product Codes
ILY   OLP  
Date Received06/27/2024
Decision Date 10/11/2024
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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