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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 K223618
Device Name IPL Hair Removal Device, Model(s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD
Applicant
Shenzhen Ulike Smart Electronics Co., Ltd.
#8, Keyuan Rd., Yuehai Sub-District,
Nanshan District
Shenzhen,  CN 518000
Applicant Contact Shane Xie
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center, # 3101-90,
Qianhai Rd.
Guangdong,  CN 518052
Correspondent Contact Riley Chen
Regulation Number878.4810
Classification Product Code
OHT  
Date Received12/05/2022
Decision Date 02/28/2023
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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