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510(k) Data Aggregation

    K Number
    K230473
    Device Name
    IPL Hair Removal Device Models: MLY-T069
    Manufacturer
    Miley Technology(Hebei) Co., Ltd.
    Date Cleared
    2023-06-15

    (113 days)

    Product Code
    OHT
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The IPL Hair Removal Device is an over-the-counter device used to remove excess hairs for adults, suitable for home or medical institution use. The device is used for adults with Fitzpatrick skin types I-IV.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies related to the IPL Hair Removal Device.

    The text is a 510(k) clearance letter from the FDA, confirming that the device is substantially equivalent to legally marketed predicate devices. It outlines regulatory requirements and provides contact information but does not contain the specific study results or performance data you are requesting.

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