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    K Number
    K243453
    Device Name
    Philips Lumea IPL
    Manufacturer
    Philips Consumer Lifestyle B.V.
    Date Cleared
    2025-02-10

    (95 days)

    Product Code
    OHT, GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Philips Consumer Lifestyle B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Philips Lumea IPL is indicated for the removal of unwanted hair for a single user. It is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
    Device Description
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