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510(k) Data Aggregation

    K Number
    K013940
    Device Name
    LASER SYSTEM YELLOWSTAR
    Manufacturer
    ASCLEPION-MEDITEC AG
    Date Cleared
    2002-02-26

    (89 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K932723,K942934,K883541,K903883
    Why did this record match?
    Device Name :

    LASER SYSTEM YELLOWSTAR

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

    The Laser System YellowStar intended for treatment of vascular and pigmented lesions.

    Device Description

    The Laser System YellowStar consists of a laser enclosure, fiber optic delivery system and an computer controlled treatment parameter interface.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for the ASCLEPION-MEDITEC AG Laser System YellowStar, which focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than providing performance data from a specific study.

    Specifically, the "Performance data" section states: "None. The specifications and intended uses of the laser system YellowStar are the same or very similar to those of claimed predicate devices. Because of this, performance data were not required."

    Therefore, I cannot populate the table or answer the questions regarding acceptance criteria and study details based on the provided text.

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