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

    Hand-held IPL device(JOVS Graphene Hair Removal Device)

    K Number: K214113 · Decision Mar 28, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    91
    Same Product Code
    161
    Applicant Total
    6
    Review Days
    88

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    Basic Information

    Device Name
    Hand-held IPL device(JOVS Graphene Hair Removal Device)
    K Number
    K214113
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Qianyu Technology Co., Ltd.
    Date Received
    December 30, 2021
    Decision Date
    March 28, 2022
    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

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

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    Other Clearances by Shenzhen Qianyu Technology Co., Ltd.

    K Number Device Name
    K250227 JOVS Electric Stimulation Beauty Device (JE2)
    K244020 Wrinkle Treatment Device (JM1, JM2B)
    K240360 Wrinkle Treatment Device (JM2)
    K231800 IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9
    K220645 Hand-held IPL device (JOVS Hair Removal Device)