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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 Hair Removal
510(k) Number K243017
Device Name IPL Hair Removal Device (NV-TM10A, NV-TM10C, NV-TM10D)
Applicant
Foshan Newface Electronic Technology Co., Ltd.
Floor 4--5, #13, Hengsan Rd., Shabu Industrial, Shachong,
Lishui Town Nanhai District
Foshan,  CN 528244
Applicant Contact Jiazhen Peng
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center, # 3101-90, Qia
Shenzhen,  CN 518052
Correspondent Contact Riley Chen
Regulation Number878.4810
Classification Product Code
OHT  
Date Received09/27/2024
Decision Date 05/06/2025
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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