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510(k) Data Aggregation

    K Number
    DEN200063
    Device Name
    Kerasave
    Manufacturer
    AL.CHI.MI.A. S.r.l
    Date Cleared
    2022-05-02

    (578 days)

    Product Code
    QCW
    Regulation Number
    886.4320
    Why did this record match?
    Applicant Name (Manufacturer) :

    AL.CHI.MI.A

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Kerasave is indicated for storage of human corneas at 2-8°C for up to 14 days. It is intended for prescription (Rx) use by physicians or highly skilled personnel, such as Eye Bank operators.
    Device Description
    Kerasave is made of a buffered corneal storage medium, which provides basic nutrients for cell maintenance during storage of donor corneas at 2-8°C for up to 14 days, at physiological pH. The device also includes antimicrobial agents. The antibiotics are dissolved in the solution and an antifungal agent is formulated as a tablet for stability reason and constitutes integral part of the device; it shall be dissolved in the medium prior to use.
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    K Number
    K162013
    Device Name
    Eusol-C
    Manufacturer
    AL.CHI.MI.A. S.r.l.
    Date Cleared
    2016-09-15

    (56 days)

    Product Code
    LYX
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    AL.CHI.MI.A

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Eusol-C is indicated when it is desired to store explanted corneas for up to 14 days. It is intended for use by physicians or highly skilled personnel, such as Eye Bank operators.
    Device Description
    Not Found
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    K Number
    K063617
    Device Name
    EUSOL-C
    Manufacturer
    AL.CHI.MI.A
    Date Cleared
    2007-02-08

    (65 days)

    Product Code
    LYX
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    AL.CHI.MI.A

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Eusol-C is sterile medium for hypothermic corneal storage intended for corneal storage at 4℃ for up to 14 days, to be used by physicians or highly skilled personnel. Eusol-C is indicated when it is desired to store explanted corneas for up to 14 days. It is intended for use by physicians or highly skilled personnel, such as Eye Bank operators.
    Device Description
    Eusol-C is sterile medium for hypothermic corneal storage intended for corneal storage at 4°C for up to 14 days, to be used by physicians or highly skilled personnel, such as Eye Bank operators. EUSOL-C can be stored at 2-25°C until ready for use. Based on stability studies, peak temperatures up to 42°C do not affect EUSOL-C parameters and performances.
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    K Number
    K032422
    Device Name
    EUSOL-C
    Manufacturer
    AL.CHI.MI.A
    Date Cleared
    2003-12-15

    (132 days)

    Product Code
    LYX
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    AL.CHI.MI.A

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Eusol-C is indicated for corneal storage for up to 14 days. Eusol-C is indicated for the storage of donor corneas for up to 14 days.
    Device Description
    Eusol-C is sterile medium for hypothermic corneal storage intended for corneal storage at 4℃ for up to 14 days.
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