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510(k) Data Aggregation

    K Number
    K222598
    Date Cleared
    2022-11-17

    (80 days)

    Product Code
    Regulation Number
    878.4810
    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 home or medical institution use.

    Device Description

    Not Found

    AI/ML Overview

    The provided text describes an FDA 510(k) clearance for an IPL Hair Removal Device. It does not contain any information about acceptance criteria or a study that proves the device meets such criteria.

    The document is a clearance letter and an Indications for Use statement, which confirm the device's substantial equivalence to predicate devices and state its intended use as an over-the-counter hair removal device for home or medical institution use.

    Therefore, I cannot provide the requested information as it is not present in the given text.

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