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510(k) Data Aggregation

    K Number
    K240378
    Device Name
    FAQ™ 201, FAQ™ 202
    Manufacturer
    Foreo Inc.
    Date Cleared
    2024-04-19

    (72 days)

    Product Code
    OHS,OLP
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FAQ™ 201, FAQ™ 202

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

    FAO™ 201 and 202 devices are intended to use LED light for the treatment of wrinkles and mild to moderate acne.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for the Faq™ 201 and Faq™ 202 devices. This type of document determines substantial equivalence to a predicate device and includes the Indications for Use. However, it does not include detailed information about acceptance criteria, study methodologies, sample sizes, ground truth establishment, or multi-reader multi-case studies as requested in the prompt.

    Therefore, I cannot extract the requested information from the provided text. The document focuses on regulatory clearance based on substantial equivalence, not on the specific performance study details that would define and prove acceptance criteria.

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