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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 K232056
Device Name IPL Hair Removal Device, Model(s): PB1, PB2, PB3, PB4, TM002
Applicant
Dongguan Lide Electric Appliance Co., Ltd.
Floor 4, Bldg. 2, #11 Yinhe Fifth Rd., Qiaotou Town
Dongguan,  CN 523528
Applicant Contact Xiang Guojun
Correspondent
Feiying Drug & Medical Consulting 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 Received07/11/2023
Decision Date 10/06/2023
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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