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510(k) Data Aggregation

    K Number
    K971009
    Device Name
    SCAR CARE
    Manufacturer
    TARGET HEALTH, INC.
    Date Cleared
    1997-07-29

    (131 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

    For the management of hypertrophic or keloid scars.

    SCAR CARE™ is intended for use in the management of hypertrophic and keloid scars.

    Device Description

    SCAR CARE™ is a device composed of an outer shell consisting of medical grade silicone sheets adherent to each other with a sealed internal component filled with medical grade silicone oil. It is a soft, semi-transparent rubbery device.

    AI/ML Overview

    This document is a 510(k) summary for the SCAR CARE™ device and does not contain information about acceptance criteria or a study proving the device meets said criteria.

    The provided text focuses on:

    • The FDA's 510(k) clearance letter for SCAR CARE™.
    • General information about the regulatory process for medical devices.
    • A 510(k) summary for SCAR CARE™ detailing its trade name, common name, predicate device (TopiGel™ Gel Sheeting), description, and intended use.

    Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets them, as it is not present in the given text.

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