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510(k) Data Aggregation

    K Number
    K972872
    Device Name
    DERMA K LASER SYSTEM
    Manufacturer
    ESC MEDICAL SYSTEMS LTD.
    Date Cleared
    1997-10-28

    (85 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K965015,K964253
    Why did this record match?
    Device Name :

    DERMA K LASER SYSTEM

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

    The Derma™ K laser system is intended for incision, excision, ablation, vaporization and hemostasis of soft tissuc.

    Device Description

    The Derma™ K is a surgical laser system that produces laser (infrared) energy at wavelengths of 2.94 and 10.6 microns which is directed to soft tissue through an articulated arm system with removable handpieces.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria.

    The document is a 510(k) summary for the Derma™ K laser system, issued in 1997. It describes the device, its intended use, and its technological characteristics in comparison to predicate devices, to establish substantial equivalence.

    Specifically, under section 9, "Clinical and Non-clinical Performance Data," the document states: "None submitted." This indicates that no performance data, clinical or non-clinical, was provided as part of this submission for the Derma™ K laser system. Therefore, details regarding acceptance criteria, sample sizes, ground truth establishment, expert adjudication, or MRMC studies are absent.

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