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510(k) Data Aggregation

    K Number
    K172689
    Device Name
    DESCRIBE PFD Patch
    Manufacturer
    Merz North America, Inc.
    Date Cleared
    2017-11-29

    (84 days)

    Product Code
    PKO
    Regulation Number
    878.4810
    Why did this record match?
    Product Code :

    PKO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DESCRIBE PFD Patch is indicated for use as an accessory to laser tattoo removal procedures using 532, 694, 755, and 1064 nm standard Q-Switched (QS) lasers and 532, 755, 785, and 1064 nm standard picosecond lasers in Fitzpatrick Skin Type I-III patients.
    Device Description
    The DESCRIBE® PFD Patch consists of two components: a dual-layer medicalgrade silicone transparent film, and an optical clearing agent (OCA). The dual-layer silicone film is composed of a thin low-friction silicone membrane and a tacky silicone polymer layer. The low-friction silicone membrane forms the upper layer of the film. The tacky silicone polymer layer (i.e., the lower layer) contacts the patient's skin during the device's use. The OCA in the Device is sterile, high-purity perfluorodecalin (PFD), an inert, non-toxic liquid (FluoroMed, LLC).
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    K Number
    K150212
    Device Name
    DeScribe Transparent PFD Patch
    Manufacturer
    ON Light Sciences, Inc.
    Date Cleared
    2015-04-20

    (80 days)

    Product Code
    PKO
    Regulation Number
    878.4810
    Why did this record match?
    Product Code :

    PKO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Describe® Transparent PFD Patch is indicated for use as an accessory to laser tattoo removal procedures using a 755nm Q-Switched Alexandrite laser in Fitzpatrick Skin Type I-III patients.
    Device Description
    The DeScribe Patch consists of two components: a dual-layer medical-grade silicone transparent film, and an optical clearing agent (OCA). The dual-layer silicone film is composed of a thin low-friction silicone membrane and a tacky silicone polymer layer. The low-friction silicone membrane forms the upper layer of the film. The tacky silicone polymer layer (i.e., the lower layer) contacts the patient's skin during the device's use. The OCA in the Device is sterile, high-purity perfluorodecalin (PFD), an inert, non-toxic liquid.
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