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510(k) Data Aggregation

    K Number
    K211362
    Device Name
    SCAR 3
    Date Cleared
    2021-08-25

    (114 days)

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

    EL. En Electronic Engineering SPA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SCAR 3 scanner, when used with DEKA Smartxide family lasers (K180193), is indicated for ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery. The SCAR 3 scanner, when used with DEKA Smartxide family lasers (K180193), is indicated for use in the performance of specific applications in dermatology and plastic surgery as follows: -The ablation, vaporization, excision, incision, and coagulation of soft tissue in the performance of laser burn debridement -Laser skin resurfacing (ablation and/or vaporization) for treatment of: · Wrinkles, rhytids, and furrows (including fine lines and texture irregularities) -Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: - Acne scars - · Surgical scars
    Device Description
    The SCAR 3 scanning unit is an optional scanner that can be connected to the Deka SmartXide family lasers (K180193). The SCAR 3 is composed of the following components: - HiScan SCAR 3 head - HiScan SCAR 3 cable Laser emission parameters are selected through the GUI of the DEKA laser device to whom the scanner is connected. Shape and size of the scanning area may also be selected by using the three keys on the scanning head.
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