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510(k) Data Aggregation

    K Number
    K992146
    Device Name
    SCARAID SILICONE GEL SHEETING
    Manufacturer
    BIODERMIS CORP.
    Date Cleared
    1999-07-30

    (36 days)

    Product Code
    MDA
    Regulation Number
    878.4025
    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

    Scaraid is intended for the management of hypertrophic and keloid scars and it is not intended to be used on open wounds.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called "ScarAid Silicone Gel Sheeting". It does not contain information about acceptance criteria or a study proving the device meets those criteria, as it is a regulatory document addressing the substantial equivalence of the device to a predicate device already on the market.

    Therefore, I cannot extract the requested information from the provided text. The document confirms that the device is deemed "substantially equivalent" for the management of hypertrophic and keloid scars but does not detail performance metrics, study designs, or ground truth establishment.

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