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510(k) Data Aggregation

    K Number
    K093144
    Device Name
    LOUSEBUSTER
    Manufacturer
    LARADA SCIENCES
    Date Cleared
    2009-12-16

    (72 days)

    Product Code
    LJL
    Regulation Number
    880.5960
    Why did this record match?
    Applicant Name (Manufacturer) :

    LARADA SCIENCES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LouseBuster™ is intended for use to kill or remove lice and lice eggs in the head hair of adults and children 4 years of age and older.
    Device Description
    The LouseBuster (LB) is a portable, electrically powered, reusable, device that can be used to direct controlled, heated airflow to kill Lice on the hair and scalp of patients with head lice infestations. The device consists of an applicator, a flexible delivery hose, and a base unit comprising heating and air movement elements with associated safety monitoring and temperature control circuitry. The mechanical and electrical components of the device are protected in a molded, non-metallic housing. A detachable delivery hose provides a pathway for channeling the flowing, heated air created in the base unit to the single-use, disposable applicator. The single-use applicator is attached to the hose by the user before initiating LB treatment. During treatments, the applicator is manually positioned by the user to systematically direct heated air to kill or remove lice present in the scalp and hair roots of an infested individual.
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    K Number
    K083206
    Device Name
    LOUSEBUSTER
    Manufacturer
    LARADA SCIENCES
    Date Cleared
    2009-03-10

    (130 days)

    Product Code
    LJL
    Regulation Number
    880.5960
    Why did this record match?
    Applicant Name (Manufacturer) :

    LARADA SCIENCES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LouseBuster™ is intended for use to kill or remove lice and lice eggs in the head hair of adults and children 4 years of age and older.
    Device Description
    The LouseBuster (LB) is a portable, electrically powered, reusable, prescription-use device that can be used to direct controlled, heated airflow to kill Lice on the hair and scalp of patients with head lice infestations. The device consists of an applicator, a flexible delivery hose, and a base unit comprising heating and air movement elements with associated safety monitoring and temperature control circuitry. The mechanical and electrical components of the device are protected in a molded, non-metallic housing. A detachable delivery hose provides a pathway for channeling the flowing, heated air created in the base unit to the single-use, disposable applicator. The single-use applicator is attached to the hose by the user before initiating LB treatment. During treatments, the applicator is manually positioned by the user to systematically direct heated air to kill or remove lice present in the scalp and hair roots of an infested individual.
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