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510(k) Data Aggregation

    K Number
    K062524
    Device Name
    OCTAX LASER SHOT SYSTEM
    Manufacturer
    MINITUBE OF AMERICA, INC
    Date Cleared
    2006-12-15

    (109 days)

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

    MINITUBE OF AMERICA, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OCTAX Laser Shot™ is a laser system for microsurgery on a cellular level, which works on a semiconductor basis. It is intended to be used to ablate a small tangential hole in the zona pellucida (assisted hatching) to be performed immediately prior to transfer on day 2 or day 3 in selected in vitro fertilization (IVF) patients with otherwise poor prognosis for successful pregnancy outcome, such as those with advanced maternal age, prior failed IVF, cyropreserved embryos, or abnormal zona pellucida characteristics. For safety reasons, the system should only be used if more than one embryo is available for transfer.
    Device Description
    The OCTAX Laser Shot™ laser device is a microscope based micromanipulation tool for use in ART in In Vitro Fertilization laboratories. The device uses a 1.48 um infrared diode laser and has been supplemented with a miniature digital video camera and computer software allowing precise laser control, image storage and database and analysis functions.
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    K Number
    K050197
    Device Name
    MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045
    Manufacturer
    MINITUBE OF AMERICA, INC
    Date Cleared
    2006-10-06

    (617 days)

    Product Code
    MQG
    Regulation Number
    884.6120
    Why did this record match?
    Applicant Name (Manufacturer) :

    MINITUBE OF AMERICA, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Minitube SC-2000 + 2045 temperature control unit is indicated maintaining the temperature of biological material like gametes and embryos at a certain temperature which is essential to rover multiple applications in reproductive medicine, biology and other areas.
    Device Description
    The Minitube Temperature Control Unit SC-2000 & SC-2045 is a temperature control unit. The only distinguishing feature between the SC-2000 and the SC-2045 is that the inserts on the warming plates of the SC-2045 are at a 45 degree angle from a level horizontal plane, whereas the SC-2000 inserts are vertical to that plane.
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