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

    DERMA-LASE RUBY LASER - MODEL DLR-1

    K Number: K913256 · Decision Jan 22, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    476
    Registration Numbers
    479
    Same Product Code
    2793
    Applicant Total
    5
    Review Days
    190

    Basic Information

    Device Name
    DERMA-LASE RUBY LASER - MODEL DLR-1
    K Number
    K913256
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    DERMA-LASE CO.
    Date Received
    July 16, 1991
    Decision Date
    January 22, 1992
    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 DERMA-LASE CO.

    K Number Device Name
    K932156 MULTILINE; DLY-1
    K930975 DERMA-LASE DLA-1 LASER
    K930793 MULTILINE; DLY-1
    K924647 DLR-1 DERMA-LASE RUBY LASER/DLR-1/DERMA-LASE SYST