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

    SUNTECH MODELS 3001 ALLSTAR & 3401 GALAXY

    K Number: K850660 · Decision Mar 1, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    271
    Applicant Total
    1
    Review Days
    9

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    Basic Information

    Device Name
    SUNTECH MODELS 3001 ALLSTAR & 3401 GALAXY
    K Number
    K850660
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4630
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Suntech USA, Inc.
    Date Received
    February 20, 1985
    Decision Date
    March 1, 1985
    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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