Search Filters

Search Results

Found 8 results

510(k) Data Aggregation

    K Number
    K221759
    Device Name
    Cornisol
    Manufacturer
    Aurolab
    Date Cleared
    2022-10-05

    (110 days)

    Product Code
    LYX
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LYX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CORNISOL is a corneal storage solution for storage of human cornea suitable for keratoplasty for up to 14 days under refrigeration (2-8°C).
    Device Description
    Cornisol is a sterile hypothermic corneal storage medium intended for human corneal storage between 2 and 8℃ for up to 14 days. Cornisol is for single use and to be used only by physicians or highly skilled personnel such as eye bank operators. Corneas are directly placed in Cornisol medium after surgery with a storage time based on the time needed to obtain serology results of the donor but for a period of time of no more than 14 days.
    Ask a Question
    K Number
    K211786
    Device Name
    Independent Corneal Viewing Chamber (IVC-21)
    Manufacturer
    Bausch + Lomb, Incorporated
    Date Cleared
    2021-12-03

    (177 days)

    Product Code
    LYX
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LYX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Independent Viewing Chamber (IVC-21) is a sterile container that may be used for the transportation of corneal tissue preserved in Optisol GS storage media.
    Device Description
    The Independent Corneal Viewing Chamber (IVC) is a sterile container (consisting of a jar, lid, and o-ring) that may be used for transportation of corneal tissue preserved in Optisol GS storage media.
    Ask a Question
    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?
    Product Code :

    LYX

    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
    Ask a Question
    K Number
    K151061
    Device Name
    Cornea Cold
    Manufacturer
    EUROBIO
    Date Cleared
    2015-08-06

    (108 days)

    Product Code
    LYX
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LYX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hypothermic (2-8°C) human corneal storage for 14 days
    Device Description
    Cornea Cold® is a sterile hypothermic corneal storage medium intended for human corneal storage at 2-8°C, for up to 14 days. Corneas are directly placed in Cornea Cold storage medium after surgery, and stored in eye banks between +2°C for a maximum of 2 weeks. The shortest storage time is determined by the time needed to obtain serology results of the donor. It is for single use, to be used by physicians or highly skilled personnel such as bank operators. The device gets into direct contact with the patient by accumulation in the cornea graft.
    Ask a Question
    K Number
    K063304
    Device Name
    LIFE4C
    Manufacturer
    NUMEDIS, INC.
    Date Cleared
    2007-12-21

    (415 days)

    Product Code
    LYX
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LYX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LIFE4°C is indicated for storage of human corneas suitable for keratoplasty up to 14 days under refrigeration (2-8°C).
    Device Description
    Life49C is sterile, non-pyrogenic, advanced buffered corneal preservation medium which is supplemented with chondroitin sulfate (membrane stabilizer), recombinant human insulin (cell metabolism enhancer), Dextran (osmotic agent), glutathione (antioxidant, free-radical scavenger, enzyme cofactor), stabilized L-glutamine , ATP precursors, nutrient cell supplements, amino acids, vitamins, trace elements, gentamycin, streptomycin and phenol red (pH indicator).
    Ask a Question
    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?
    Product Code :

    LYX

    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.
    Ask a Question
    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?
    Product Code :

    LYX

    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.
    Ask a Question
    K Number
    K954548
    Device Name
    THE CHEN MEDIUM
    Manufacturer
    CHEN OPHTHALMIC LABORATORIES
    Date Cleared
    1996-05-20

    (231 days)

    Product Code
    LYX
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LYX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

    Page 1 of 1