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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 K250171
Device Name IPL Hair Removal Device (BE965A, BE965B, BE965C)
Applicant
Shenzhen Yang WO Electronic Co., Ltd.
101# 3bldg, The Third Industry, Shangshi Jia Village
Shijia Community, Matian St., Guangming District
Shenzhen,  CN 518106
Applicant Contact Ken Wang
Correspondent
Feiying Drug & Medical Consultting Technical Service Group
Rm.2401 Zhenye International Business Center,
# 3101-90 Qianhai Rd.
Shenzhen,  CN 518052
Correspondent Contact Riley Chen
Regulation Number878.4810
Classification Product Code
OHT  
Date Received01/21/2025
Decision Date 03/19/2025
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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