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    K Number
    K253754

    Validate with FDA (Live)

    Device Name
    Philips Lumea IPL
    Manufacturer
    Philips Consumer Lifestyle B.V.
    Date Cleared
    2025-12-23

    (28 days)

    Product Code
    OHT
    Regulation Number
    878.4810
    Type
    Special
    Panel
    General & Plastic Surgery
    Age Range
    18 - 65
    Reference & Predicate Devices
    K243453
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    Philips Lumea IPL is an Intense Pulsed Light (IPL) device intended for removal of unwanted hair. The device is to be used by persons in the age range of 18-65 years with fair up to medium brown skin tones, and naturally dark blond, brown, dark brown and black hair.

    The Philips Lumea IPL applies spectrally adjusted light to the user skin, which is absorbed by the melanin and after some applications hair sheds naturally and growth is delayed or inhibited.

    The Philips Lumea IPL is an Over-the-counter hand-held device powered by a wall mount adapter. It is provided in a non-sterile state and intended to be used by single person for multiple uses in homecare environment.

    AI/ML Overview

    N/A

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