BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇪 Sweden

    FREE SUN PRO DESIGN 3000 AND 3800

    K Number: K925171 · Decision Dec 29, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    271
    Applicant Total
    1
    Review Days
    76

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    Basic Information

    Device Name
    FREE SUN PRO DESIGN 3000 AND 3800
    K Number
    K925171
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4630
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Free Sun Prod. AB
    Date Received
    October 14, 1992
    Decision Date
    December 29, 1992
    Product Code
    FTC
    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
    FTC Light, Ultraviolet, Dermatological

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