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510(k) Data Aggregation

    K Number
    K082043
    Device Name
    CARRIAZO-PENDULAR MICROKERATOME
    Manufacturer
    SCHWIND EYE-TECH-SOLUTIONS GMBH & CO. KG
    Date Cleared
    2008-08-01

    (14 days)

    Product Code
    HNO
    Regulation Number
    886.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    **SCHWIND EYE-TECH-SOLUTIONS GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Carriazo-Pendular Microkeratome is indicated for shaving the cornea prior to lamellar (partial thickness) transplant or to create a flap in the cornea.
    Device Description
    The Carriazo-Pendular is an AC powered microkeratome. Cutting head and blade are designed in a convex form similar to the cornea itself. Due to the unique pendulum motion of the Carriazo-Pendular, the cornea becomes more applanated in the center than in the periphery. This technology provides a homogeneous and predictable flap thickness and smooth cutting edges. The Carriazo-Pendular consists of: Carriazo-Pendular console, Cutting heads, Suction rings, Foot switches, Monitoring software.
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    K Number
    K032910
    Device Name
    CARRIAZO PENDULAR
    Manufacturer
    SCHWIND EYE-TECH-SOLUTIONS GMBH & CO. KG
    Date Cleared
    2004-08-30

    (343 days)

    Product Code
    HNO
    Regulation Number
    886.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    **SCHWIND EYE-TECH-SOLUTIONS GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Carriazo Pendular Microkeratome is indicated for shaving the cornea prior to lamellar (partial thickness) transplant or to create a flap in the cornea.
    Device Description
    The Carriazo Pendular Microkeratome is a Keratome (microkeratome). Selected differences in specifications between the Carriazo-Pendular (CP) Microkeratome and its predicates include head/ring coupling (the CP couples automatically; predicates use manual coupling); the CP vacuum is adjustable to 675 mm Hg; the predicates are constant at 625 mm Hg); the CP has a double-headed vacuum pump and the predicates single-headed vacuum pumps; the CP electronically detects and signals a cable break; the predicates lack this feature); shape of the blade (CP is curved: the predicates are straight); the CP has a ball-shaped cutting head; the predicates are straight; at the stop in final position - the CP is automatic; the predicates are not; the CP has right and left eye rings, the predicates do not; and the CP head is guided by two separate mains; the predicates by a single pivot on the ring only and the head can move up and down during the cut which can result in micro-scattering on the stromal bed).
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