BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MateLaser Medical Diode Laser Systems (ML-DLS-30)

    K Number: K250731 · Decision Oct 16, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    16
    Applicant Total
    2
    Review Days
    219

    Basic Information

    Device Name
    MateLaser Medical Diode Laser Systems (ML-DLS-30)
    K Number
    K250731
    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
    Matelaser, Inc.
    Date Received
    March 11, 2025
    Decision Date
    October 16, 2025
    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 Matelaser, Inc.

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    K250195 MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60)