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510(k) Data Aggregation

    K Number
    K091754
    Device Name
    LUNETTE MENSTRUAL CUP, MODELS 1 AND 2
    Manufacturer
    LUNE GROUP LTD.
    Date Cleared
    2009-11-13

    (150 days)

    Product Code
    HHE
    Regulation Number
    884.5400
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUNE GROUP LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lunette Menstrual Cup (Models 1, 2) is a receptacle placed in the vagina to collect blood and cellular debris that is extruded from the uterus via the cervix during menstruation.
    Device Description
    The Lunette™ menstrual cup is a soft, small internally worn reusable silicone menstrual cup that holds (instead of absorbing) monthly menstrual flow. It may remain in the body for up to 12 hours. It holds an ounce of fluid. It is available in two sizes: - Size 1 for light flow and women who have not had intercourse (diameter of 41 . mm, a height of 73 mm, and a volume of 25 ml) - . Size 2 for heavy flow (diameter of 45 mm, a height of 78 mm, and a volume of 30 ml) The cup remains entirely within the vagina and does not touch the cervix but the stem remains outside the body to ensure retrieval of the cup. The user's guide provides information about how to use and care for the Lunette™ menstrual cup (Attachment 5). Lunette™ menstrual cup is a re-useable internal receptacle that is placed in the vagina to collect blood and cellular debris that is extruded from the uterus via the cervix during menstruation. Lunette™ Menstrual Cup is positioned in the lower portion of the vagina. The cup does not touch the cervix or interfere with the menstrual flow through it.
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