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510(k) Data Aggregation

    K Number
    K213220
    Device Name
    Revaree Plus Vaginal Suppositories
    Manufacturer
    Date Cleared
    2022-06-21

    (265 days)

    Product Code
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Farma-Derma S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Revaree plus vaginal suppositories are a personal lubricant, for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
    Device Description
    Farma-Derma's Revaree plus vaginal suppositories is a non-sterile solid preparation personal lubricant containing hyaluronic acid, sweet almond oil, and glycerides. It is presented in the form of vaginal suppositories, 2 g in weight. Each vaginal suppository is individually packed in a polyvinyl chloride (PVC)/polyethylene (PE) blister. The device is available for sale in a pack containing 10 vaginal suppositories (two blisters of 5 vaginal suppositories each) while the sample pack contains 3 vaginal suppositories (one blister). Due to its shape the device can be easily introduced into the vaginal cavity by finger. When the vaginal suppository is in contact with the vaginal mucosa, it melts due to body temperature and becomes a viscous mass which remains in contact with the vaginal mucosa, creating a moist environment to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication.
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    K Number
    K153372
    Device Name
    Repagyn vaginal suppositories
    Manufacturer
    Date Cleared
    2016-06-30

    (220 days)

    Product Code
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    FARMA-DERMA S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Repagyn is a personal lubricant, for vaginal application, intended to moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
    Device Description
    The Farma-Derma Repagyn Vaginal Suppositories are a non-sterile hyaluronic acid and glycerides based semi-solid preparation presented in the form of vaginal suppositories of 2 g in weight individually packed in a polyvinyl chloride (PVC)/polyethylene (PE) blister. The device is available for sale in a pack containing 10 vaginal suppositories (two blisters of 5 vaginal suppositories each) while the sample pack contains 3 vaginal suppositories (one blister). Due to its specific shape the device can be introduced into the vaginal cavity using a finger. Repagyn Vaginal Suppositories are a Hyaluronic acid (HA) based product; the HA is mixed in with semi-synthetic glycerides that represent the major quantity of material used in the formulation. When the vaginal suppository is in contact with the vaginal mucosa it melts due to body temperature and becomes a viscous mass which remains in contact with the vaginal mucosa. It acts similarly to other vaginal creams or gels for topical application with Hyaluronic acid based formulations.
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