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510(k) Data Aggregation

    K Number
    K240616
    Device Name
    FAQ™ (102)
    Manufacturer
    Foreo Inc.
    Date Cleared
    2024-07-15

    (132 days)

    Product Code
    PAY,NFO,OHS
    Regulation Number
    878.4420
    Type
    Traditional
    Panel
    Physical Medicine (PM)
    Reference & Predicate Devices
    K190479
    Why did this record match?
    Reference Devices :

    K190479

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    FAQ™ 102 devices are over-the-counter home use devices intended for facial and neck skin stimulation, and non-invasive treatments of mild to moderate facial wrinkles for adult women with all skin tones.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a device named FAQ™ (102), stating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory requirements, classifications, and indications for use but does not detail performance studies or acceptance criteria.

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