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

    DeScribe Transparent PFD Patch

    K Number: K150212 · Decision Apr 20, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    80

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    Basic Information

    Device Name
    DeScribe Transparent PFD Patch
    K Number
    K150212
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    On Light Sciences, Inc.
    Date Received
    January 30, 2015
    Decision Date
    April 20, 2015
    Product Code
    PKO
    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
    PKO Transparent Patch For Use In Treatment Of Tattoos

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (PKO), ordered by most recent decision date.

    DESCRIBE PFD Patch

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
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