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510(k) Data Aggregation

    K Number
    K241150
    Device Name
    MISTI Silicone Implant
    Manufacturer
    Keosan Trading Co.
    Date Cleared
    2024-07-24

    (90 days)

    Product Code
    MIB, FWP, FZE, LZK, MIC
    Regulation Number
    874.3620
    Why did this record match?
    Applicant Name (Manufacturer) :

    Keosan Trading Co.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MISTI Silicone Implant is intended for the augmentation of the nasal, malar, chin, gluteal, calf and/or pectoral contour.
    Device Description
    The MISTI Silicone Implant offers various types including Nasal, Chin, Mid-face, Forehead, Block, Temple, Gluteal, Calf and Pectoral. The Nasal, Chin, Mid-face, Forehead, Gluteal, Calf and Pectoral are used for the areas indicated in the type names. The Block type is used for various areas during plastic and reconstruction surgeries. The Temple type can be used on a juncture where four skull bones fuse together so called the temple region. It is made of implant grade silicone elastomer, and the design characteristic minimizes carving and promotes natural line.
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    K Number
    K232593
    Device Name
    FITme Customized Silicone Implant
    Manufacturer
    Keosan Trading Co.
    Date Cleared
    2023-11-22

    (89 days)

    Product Code
    FWP, 21C, KKY
    Regulation Number
    878.3550
    Why did this record match?
    Applicant Name (Manufacturer) :

    Keosan Trading Co.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FITme Customized Silicone Implant is intended for augmentation, reconstructive and cosmetic surgery of the facial regions. The FITme Customized Silicone Implant is pre-shaped to the surgeon's specification to meet the needs of a particular patient.
    Device Description
    The FITme Customized Silicone Implant is a patient-specific medical device intended for augmentation, reconstructive and cosmetic surgery of facial region, specifically the nasal contour, the malar cheek contour, and chin contour. The device is a single use implant intended for long term implantation as a space occupying device to form a contoured feature. The customized implant, FITme Customized Silicone Implant, is made of implant grade silicone elastomer, in a range of durometers as specified by the surgeon. The patient's own medical imaging (e.g., Computed Tomography (CT) scan) is translated into a digital model of the patient's skull using the software, Mimics by Materialise. At the recommendation of the surgeon, the Mimics is used either to 3D-print a skull model for the surgeon to fashion a solid implant model with commercially available plaster or to create a digital implant model as an STL file. KEOSAN TRADING Co. manufactures the customized molds from the solid implant model provided by the surgeon, or the digital implant model provided by KEOSAN TRADING Co., using plaster molds or 3D-printed molds as appropriate. The FITme Customized Silicone Implant is manufactured from the customized molds and provided to the surgeon, non-sterile.
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