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

    IPL Hair Removal Device (I6 S1, I6 D1, I6 M1)

    K Number: K252618 · Decision Nov 14, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    91
    Same Product Code
    161
    Applicant Total
    1
    Review Days
    87

    Basic Information

    Device Name
    IPL Hair Removal Device (I6 S1, I6 D1, I6 M1)
    K Number
    K252618
    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
    Alovea Healthcare Co. , Ltd.
    Date Received
    August 19, 2025
    Decision Date
    November 14, 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

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