BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    DMS-1000C DERMOABRADER

    K Number: K963204 · Decision Dec 9, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    153
    Registration Numbers
    153
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    116

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    Basic Information

    Device Name
    DMS-1000C DERMOABRADER
    K Number
    K963204
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4820
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Aesthetic Lasers, Inc.
    Date Received
    August 15, 1996
    Decision Date
    December 9, 1996
    Product Code
    GFE
    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
    GFE Brush, Dermabrasion, Powered

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