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510(k) Data Aggregation

    K Number
    K232242
    Device Name
    BEAR 2 Body
    Manufacturer
    FOREO Inc.
    Date Cleared
    2024-05-13

    (290 days)

    Product Code
    NFO
    Regulation Number
    882.5890
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BEAR 2 Body

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

    The device is intended for body skin stimulation and is indicated for over-the-counter cosmetic use.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for the FOREO Inc. BEAR 2 Body device. This letter indicates that the device has been found substantially equivalent to a predicate device and is intended for over-the-counter cosmetic use.

    However, the document does not contain any of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies. The FDA clearance letter itself does not typically include such detailed technical study reports.

    Therefore, I cannot provide the requested information based on the text provided.

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