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510(k) Data Aggregation

    K Number
    K120573
    Device Name
    MEDART 620
    Manufacturer
    Date Cleared
    2012-06-13

    (107 days)

    Product Code
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDART A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Dermatology, Plastic & General Surgery The CO2 laser, model MedArt 620, is intended to be used by physicians in the performance of the following specialties: The ablation and coagulation of soft tissue in dermatology, plastic and general surgery in the performance of: - Skin resurfacing I - Treatment of wrinkles and rhytids . - Treatment of furrows I - Soft tissue ablation .
    Device Description
    Not Found
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    K Number
    K110243
    Device Name
    MEDART DIODE LASER SYSTEM & ACCESSORIES
    Manufacturer
    Date Cleared
    2011-06-28

    (152 days)

    Product Code
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDART A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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.
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    K Number
    K083123
    Device Name
    MEDART MODEL 610 CO2 LASER SYSTEM & ACCESSORIES
    Manufacturer
    Date Cleared
    2009-11-24

    (398 days)

    Product Code
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDART A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Dermatology, Plastic & General Surgery The CO2 laser, model MedArt 610, is intended to be used by physicians in the performatice of the following specialities: The ablation and coagulation of soft tissue in dermatology, plastic and general surgery in the performance of: - Skin Resurfacing . - . Treatment of wrinkles and rhytids - Treatment of furrows . - Soft tissuc ablation .
    Device Description
    The MedArt 610 system comprises the following major parts: - A laser console containing a CO2 laser module capable of providing a laser beam having a wave-. length of 10,600 nm. - A scanner that is intended to manipulate and place a pulsed beam received from the laser console in . a pre-specified pattern on the skin being treated. - An optical fiber providing a beam path from the laser to the scanner. .
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