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510(k) Data Aggregation
K Number
K091754Device Name
LUNETTE MENSTRUAL CUP, MODELS 1 AND 2
Manufacturer
LUNE GROUP LTD.
Date Cleared
2009-11-13
(150 days)
Product Code
HHE
Regulation Number
884.5400Why 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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