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510(k) Data Aggregation

    K Number
    K063636
    Device Name
    ZILOS-TK
    Manufacturer
    HAMILTON THORNE BIOSCIENCES
    Date Cleared
    2007-04-24

    (138 days)

    Product Code
    MRX
    Regulation Number
    884.6200
    Why did this record match?
    Applicant Name (Manufacturer) :

    HAMILTON THORNE BIOSCIENCES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This system is intended to be used to drill a small tangential hole in or to thin the zona pellucida of the embryo in selected in vitro fertilization (IVF) patients with otherwise poor prognosis for successful pregnancy outcome, such as advanced maternal age, prior failed IVF procedures, cryopreserved embryos, or abnormal zona pellucida morphology, and in IVF patients undergoing PGD to avoid genetic disease or aneuploidy.
    Device Description
    The ZILOS-tk uses an infra-red [IR] laser beam [of wavelength in the range 1450 < 1 < 1480 nm] to locally heat a small spot on the embryo zona pellucida. The IR beam is projected through the microscope objective in a direction opposite to the image light, so that it focuses on the embryo. This epi-irradiating IR beam is confocal with the visible beam, and the user adjusts the line-up of the target to treat the exact region of the zona desired. The beam power is typically 300 mW and the beam is pulsed on for typically 500 usec or less, with a 40x objective. The thermal effect of the beam is to liquefy the zona pellucida in a small region surrounding the focal point, and thereby provide access to the embryo itself. The hole drilled in this manner can be used either to aid hatching or for biopsy cell extraction. The assembled ZILOS-tk laser system is the same length as a microscope objective and can be fitted on to the turret of any inverted microscope. It can be controlled by a desktop or laptop computer.
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    K Number
    K050768
    Device Name
    ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4
    Manufacturer
    HAMILTON THORNE BIOSCIENCES
    Date Cleared
    2005-04-28

    (34 days)

    Product Code
    MRX
    Regulation Number
    884.6200
    Why did this record match?
    Applicant Name (Manufacturer) :

    HAMILTON THORNE BIOSCIENCES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hamilton Thorne ZILOS-tk is to be used to drill a small tangential hole in or to thin the zona pellucida of the embryo in selected in vitro fertilization (IVF) patients with otherwise poor prognosis for successful pregnancy outcome, such as: Advanced maternal age Prior failed IVF Cryopreserved embryos Abnormal zona pellucida morphology
    Device Description
    The Hamilton Thorne Zona Infrared Laser Optical System [ZILOS-tkTM] 1480 nm Diode Laser for Laser Assisted Hatching [LAH].
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    K Number
    DEN040009
    Device Name
    HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK)
    Manufacturer
    HAMILTON THORNE BIOSCIENCES
    Date Cleared
    2004-11-04

    (71 days)

    Product Code
    MRX
    Regulation Number
    884.6200
    Why did this record match?
    Applicant Name (Manufacturer) :

    HAMILTON THORNE BIOSCIENCES

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

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