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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 K241998
Device Name Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S RE, UI20S PW, UI20S GP,UI20 WH, UI20 GR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20WG, UI20S WH, UI20S GR, UI20S BS, UI20S MP)
Applicant
Shenzhen Ulike Smart Electronics Co., Ltd.
810,Bldg. 1,Xunmei Science & Technology Plaza,# 8 Keyuan Rd.
Science Park Community, Yuehai Sub-District,Nanshan District
Shenzhen,  CN 518000
Applicant Contact Yang Blue
Correspondent
Shenzhen Ulike Smart Electronics Co., Ltd.
810,Bldg. 1,Xunmei Science & Technology Plaza,# 8 Keyuan Rd.
Science Park Community, Yuehai Sub-District,Nanshan District
Shenzhen,  CN 518000
Correspondent Contact Yang Blue
Regulation Number878.4810
Classification Product Code
OHT  
Date Received07/09/2024
Decision Date 12/13/2024
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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