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

    Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)

    K Number: K232222 · Decision Nov 27, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    16
    Applicant Total
    2
    Review Days
    124

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    Basic Information

    Device Name
    Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)
    K Number
    K232222
    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
    Medency S.R.L.
    Date Received
    July 26, 2023
    Decision Date
    November 27, 2023
    Product Code
    NVK
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NVK Laser, Dental, Soft Tissue

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    Other Clearances by Medency S.R.L.

    K Number Device Name
    K240543 Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)