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

    ClearLink Controlled Phototherapy Equipment

    K Number: K182215 · Decision Oct 29, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    271
    Applicant Total
    2
    Review Days
    75

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    Basic Information

    Device Name
    ClearLink Controlled Phototherapy Equipment
    K Number
    K182215
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4630
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Daavlin Distributing Company
    Date Received
    August 15, 2018
    Decision Date
    October 29, 2018
    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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    Other Clearances by Daavlin Distributing Company

    K Number Device Name
    K153749 3 Series Phototherapy Unit