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510(k) Data Aggregation

    K Number
    K250488

    Validate with FDA (Live)

    Device Name
    Cerynë Intimate Care
    Manufacturer
    Ansella Therapeutics
    Date Cleared
    2025-12-12

    (296 days)

    Product Code
    NUC
    Regulation Number
    884.5300
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Age Range
    All
    Reference & Predicate Devices
    K122477
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Ceryne Intimate Care is a silicone-based 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 natural rubber latex, and polyisoprene condoms. This product is not compatible with polyurethane condoms.

    Device Description

    Ceryne Intimate Care is a non-sterile, silicone-based personal lubricant designed to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Its formulation consists of Dimethicone, Dimethiconol Silicone blend, 2-Octyldodecanol, Cholestrol, Span 60, Stearic Acid, Tocopheryl Acetate, Arlacel 165, Cetyl Stearyl Alcohol, Sodium Benzoate, Glycogen, L-Lactic Acid and Water. This device compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms.

    The lubricant is packaged in 15g and 30g tubes.

    AI/ML Overview

    N/A

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