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510(k) Data Aggregation

    K Number
    K231794
    Device Name
    Elegant™ Advanced CompHort
    Manufacturer
    Date Cleared
    2023-12-22

    (185 days)

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

    Viramal Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Elegant™ Advanced CompHort is 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 compatible with polyurethane condoms. This product is not compatible with natural rubber latex and polyisoprene condoms.
    Device Description
    Elegant™ Advanced CompHort is a line extension to the "Elegant™" range to extend claims. It is a non-sterile, water-based, pearly white, non-irritating, non-greasy, hormone-free, paraben-free, fragrance-free, moisturizing creams for vaginal dryness. It is a personal lubricant that provides lubrication, and it is intended for ongoing use and is not exclusively for use during intimate sexual activity. The formulation of Elegant™ Advanced CompHort contains purified water, polycarbophil, carbomer homopolymer type B, labrafac, emulfree P, sorbic acid and sodium hydroxide. Elegant™ Advanced CompHort is packaged in an aluminium tube and applied using a reusable plastic applicator marked to deliver 3ml of product. Elegant™ Advanced CompHort is to be sold as an over-the-counter (OTC) product.
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    K Number
    K201612
    Device Name
    Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5
    Manufacturer
    Date Cleared
    2021-09-02

    (444 days)

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

    Viramal Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Elegant™ 2 in 1 Vaginal Moisturizer/ Elegant™ Advanced 5 is 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 compatible with polyurethane condoms. This product is not compatible with natural rubber latex and polyisoprene condoms.
    Device Description
    The subject device is a non-sterile, water-based, personal lubricant that provides lubrication during intimate sexual activity. The formulation contains purified water, polycarbophil, carbomer homopolymer type B, labrafac, emulfree P, sorbic acid and sodium hydroxide. Elegant™ 2 in 1 Vaginal Moisturizer is packaged in an aluminium tube and applied using a reusable plastic applicator marked to deliver 2ml of product. Elegant™ Advanced 5, is packaged in an aluminium tube and applied using a reusable plastic applicator marked to deliver 3ml of product. Elegant™ 2 in 1 Vaginal Moisturizer and Elegant™ Advanced 5 are personal lubricants for over-the-counter (OTC) use.
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