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510(k) Data Aggregation

    K Number
    K110243
    Device Name
    MEDART DIODE LASER SYSTEM & ACCESSORIES
    Manufacturer
    MEDART A/S
    Date Cleared
    2011-06-28

    (152 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K081015
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MedArt 720 Diode Laser System & Accessories is a prescription only device intended for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters.

    The MedArt 720 Diode Laser System & Accessories is generally indicated for incision, excision, vaporization, ablation, hemostasis, or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, and cardiothoracic surgery and ophthalmology.

    The MedArt 720 Diode Laser System & Accessories is specifically indicated for laser assisted lipolysis

    Device Description

    The MedArt® 720 laser unit is a Class 4 laser that emits invisible laser radiation. The unit is fed by a diode laser module providing continuous or pulsed wave laser beam operating at a wavelength of 980 nm that is primarily absorbed in melanin, haemoglobin and dark tissue. A limited amount of light is absorbed by water enabling fast increase in irradiated areas leading to effective heating of tissue at low power outputs.

    AI/ML Overview

    The provided text doesn't contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for the MedArt® 720 Diode Laser System & Accessories, outlining its intended use, technological characteristics compared to a predicate device, and the FDA's clearance letter.

    Therefore, I cannot provide the requested information, including:

    1. A table of acceptance criteria and the reported device performance
    2. Sample size used for the test set and the data provenance
    3. Number of experts used to establish the ground truth and their qualifications
    4. Adjudication method for the test set
    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human reader improvement with AI assistance
    6. If a standalone performance study was done
    7. The type of ground truth used
    8. The sample size for the training set
    9. How the ground truth for the training set was established
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