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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 K252804
Device Name Ice Cooling IPL Hair Removal Device (UI20S BK, UI20S BS, UI20S DB, UI20S GP, UI20S GR, UI20S MP, UI20S PW, UI20S RE, UI20S WH, UI20WG;UI20 BK, UI20 BL, UI20 BR, UI20 BS, UI20 DB, UI20 GP, UI20 GR, UI20 MP, UI20 PN, UI20 PW, UI20 RE, UI20 WH; UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB,UI06 PR, UI06 OG,UI06RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY, UI06 IG; UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU; UI04 MK, UI04 BN, UI04 BU, UI04 CB, UI04 GY, UI04 LG, UI04 DG, UI04 PL,
Applicant
Shenzhen Ulike Smart Electronics Co., Ltd.
810, Bldg. 1,Xunmei Science & Technology Plaza,#8 Keyuan Rd.
Science Park Community, Yuehai Sub-District, Nanshan Dist
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 Dist
Shenzhen,  CN 518000
Correspondent Contact Yang Blue
Regulation Number878.4810
Classification Product Code
OHT  
Date Received09/03/2025
Decision Date 10/01/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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