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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 K240016
Device Name IPL Hair Removal Device (YT01,YT02,YT03,YT04)
Applicant
Shenzhen Jianrong Biomedical Electronics Co., Ltd.
Floor 4, Bldg. 3, Haoer Jiashitai Industrial Park, #164
Fengtang Ave., Zhancheng Community, Fuhai St., Bao'An D
Shenzhen,  CN 518103
Applicant Contact Bruce Liu
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center, # 3101-90,
Qianhai Rd.
Shenzhen,  CN 518100
Correspondent Contact Yvonne Liu
Regulation Number878.4810
Classification Product Code
OHT  
Date Received01/02/2024
Decision Date 07/10/2024
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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