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510(k) Data Aggregation

    K Number
    K982827
    Device Name
    DERMA K ER:YAG/CO2 LASER
    Manufacturer
    ESC MEDICAL SYSTEMS, INC.
    Date Cleared
    1998-09-14

    (34 days)

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

    DERMA K ER:YAG/CO2 LASER

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

    The Derma™ K Laser System is intended for incision, ablation, vaporization, and hemostasis of soft tissue.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria for a device, nor does it describe a study proving a device meets such criteria.

    The text is a medical device clearance letter from the FDA (K982827 for the "Modified Derma™ Laser System"). It states that the device is "substantially equivalent" to legally marketed predicate devices and outlines general regulatory obligations. It defines the "Indications For Use" for the "Derma™ K Laser System" as "incision, ablation, vaporization, and hemostasis of soft tissue," but it does not provide details on performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the given input.

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