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Found 8 results
510(k) Data Aggregation
K Number
K221759Device Name
Cornisol
Manufacturer
Aurolab
Date Cleared
2022-10-05
(110 days)
Product Code
LYX
Regulation Number
N/AWhy 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.
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K Number
K211786Device Name
Independent Corneal Viewing Chamber (IVC-21)
Manufacturer
Bausch + Lomb, Incorporated
Date Cleared
2021-12-03
(177 days)
Product Code
LYX
Regulation Number
N/AWhy 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.
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K Number
K162013Device Name
Eusol-C
Manufacturer
AL.CHI.MI.A. S.r.l.
Date Cleared
2016-09-15
(56 days)
Product Code
LYX
Regulation Number
N/AWhy 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
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K Number
K151061Device Name
Cornea Cold
Manufacturer
EUROBIO
Date Cleared
2015-08-06
(108 days)
Product Code
LYX
Regulation Number
N/AWhy 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.
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K Number
K063304Device Name
LIFE4C
Manufacturer
NUMEDIS, INC.
Date Cleared
2007-12-21
(415 days)
Product Code
LYX
Regulation Number
N/AWhy 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).
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K Number
K063617Device Name
EUSOL-C
Manufacturer
AL.CHI.MI.A
Date Cleared
2007-02-08
(65 days)
Product Code
LYX
Regulation Number
N/AWhy 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.
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K Number
K032422Device Name
EUSOL-C
Manufacturer
AL.CHI.MI.A
Date Cleared
2003-12-15
(132 days)
Product Code
LYX
Regulation Number
N/AWhy 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.
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K Number
K954548Device Name
THE CHEN MEDIUM
Manufacturer
CHEN OPHTHALMIC LABORATORIES
Date Cleared
1996-05-20
(231 days)
Product Code
LYX
Regulation Number
N/AWhy did this record match?
Product Code :
LYX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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