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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 K241881
Device Name IPL Hair Removal Device (JM-843, JM-865, JM-638)
Applicant
Shenzhen Junmei Technology Co., Ltd.
Plant 4301, Yili Science Park, #596-4, Dahe Village,
Guancheng Community, Guanhu St., Longhua District
Shenzhen,  CN 518000
Applicant Contact Zenghui Guo
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center, # 3101-90, Qia
Shenzhen,  CN 518052
Correspondent Contact Youshan Gong
Regulation Number878.4810
Classification Product Code
OHT  
Date Received06/28/2024
Decision Date 08/29/2024
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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