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510(k) Data Aggregation

    K Number
    K072159
    Device Name
    SMART CO2 (SMARTXIDE, SMART US20D) WITH DOT SCANNER
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING SPA
    Date Cleared
    2007-12-27

    (143 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 :

    SMART CO2 (SMARTXIDE, SMART US20D) WITH DOT SCANNER

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

    The smart CO2 (SmartXide and Smart US20D) Lasers with DOT scanner are indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

    Device Description

    The Smart CO2 lasers (SmartXide, Smart US20D) are CO2 laser, having a sealed CO2 gas tube as the lasing medium. These are lasers with a wavelength of 10.6 um. Laser activation is by a footswitch. Overall weight of the laser is 30 kg, and the size is 120 cm x 48 cm x 55 cm (H x W x D). Electrical requirement is 115VAC, 15A, 50-60 Hz, single phase.

    AI/ML Overview

    This 510(k) summary for the Smart CO2 (SmartXide, Smart US20D) Laser with DOT scanner does not contain information about acceptance criteria or a study proving the device meets them.

    Instead, the submission states:

    • Nonclinical Performance Data: None
    • Clinical Performance Data: None

    The basis for clearance is substantial equivalence to a predicate device (Lumenis UltraPulse Encore). The document argues that the Smart CO2 lasers are substantially equivalent because:

    "They are both CO2 lasers with a scanning unit as an accessory, for the identical indications for use."

    Therefore, I cannot provide the requested information regarding acceptance criteria and performance studies because they are not present in the provided text.

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