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510(k) Data Aggregation

    K Number
    K971468
    Device Name
    SCAR HEAL
    Manufacturer
    SPECIALTY SYSTEMS, INC.
    Date Cleared
    1997-06-10

    (49 days)

    Product Code
    MDA
    Regulation Number
    878.4025
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPECIALTY SYSTEMS, INC.

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

    Hypertuophie Scars
    Keloid Scars

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided document, I cannot fulfill your request. The document is a 510(k) summary letter from the FDA regarding the "Scar Esthetique/Rejuvaskin" device. It primarily discusses the regulatory classification and substantial equivalence determination for the device, allowing it to be marketed.

    However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or details about any MRMC or standalone studies. It is a regulatory approval letter, not a scientific study report.

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