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510(k) Data Aggregation

    K Number
    K172439
    Device Name
    Siberian Fit
    Manufacturer
    Vydence
    Date Cleared
    2018-02-14

    (187 days)

    Product Code
    GEX
    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 Siberian Fit is intended to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections.

    Device Description

    Not Found

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a medical device called "Siberian Fit." However, it does not contain any information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, ground truth establishment, or any details related to AI or comparative effectiveness studies.

    The document is a clearance letter from the FDA, stating that the device is substantially equivalent to legally marketed predicate devices for its stated indications for use. It covers regulatory aspects like device classification, general controls, and compliance requirements.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

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