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    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    Philips Lumea IPL

    K Number: K243453 · Decision Feb 10, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    91
    Same Product Code
    161
    Applicant Total
    2
    Review Days
    95

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    Basic Information

    Device Name
    Philips Lumea IPL
    K Number
    K243453
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Philips Consumer Lifestyle B.V.
    Date Received
    November 7, 2024
    Decision Date
    February 10, 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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    Other Clearances by Philips Consumer Lifestyle B.V.

    K Number Device Name
    K253754 Philips Lumea IPL