BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    LASEmaR 1500

    K Number: K260489 · Decision May 29, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    478
    Registration Numbers
    480
    Same Product Code
    2867
    Applicant Total
    2
    Review Days
    105

    Basic Information

    Device Name
    LASEmaR 1500
    K Number
    K260489
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Eufoton S.R.L.
    Date Received
    February 13, 2026
    Decision Date
    May 29, 2026
    Product Code
    GEX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GEX Powered Laser Surgical Instrument

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    Other Clearances by Eufoton S.R.L.

    K Number Device Name
    K092860 LASEMAR 800, 1000, 1500