BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)

    K Number: K251984 · Decision Jul 24, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    91
    Same Product Code
    161
    Applicant Total
    23
    Review Days
    27

    Basic Information

    Device Name
    Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)
    K Number
    K251984
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Ulike Smart Electronics Co., Ltd.
    Date Received
    June 27, 2025
    Decision Date
    July 24, 2025
    Product Code
    OHT
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OHT Light Based Over-The-Counter Hair Removal

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (OHT), ordered by most recent decision date.

    Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)

    FDA 510(k)
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    IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B510G, FL-B510P, FL-B510M, FL-B511G, FL-B511P, FL-B511M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371, SL-B371-2, SL-B371-1, SL-B352, SL-B352-1, SL-B352-2, SL-B330-F)

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    Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017 Pro, DT017, DT025 Pro, DT025)

    FDA 510(k)
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    Other Clearances by Shenzhen Ulike Smart Electronics Co., Ltd.

    K Number Device Name
    K261325 Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)
    K260742 Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK)
    K260511 Ulike Reglow Light Therapy Device (UM10)
    K252804 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,
    K251825 Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)
    K250942 Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK)
    K250938 Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01 WG, MI01 WH, MI01 BK;UI04S PP, UI04S BU, UI04S WH, UI04S PN)
    K243749 Jmoon Conductive Gel
    K250194 Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH)
    K243393 JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)
    Search all 23 clearances from Shenzhen Ulike Smart Electronics Co., Ltd. →