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510(k) Data Aggregation
K Number
K201922Device Name
Trophikos Vaginal Moisturizer
Manufacturer
Date Cleared
2021-01-14
(188 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
Trophikos, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Trophikos Vaginal Moisturizer is a personal lubricant, for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and to supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms.
Device Description
Trophikos Vaginal Moisturizer is a water-based, non-sterile personal lubricant, and provides lubrication during intimate sexual activity. This device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists of water, glycerin, Simmondsia Chinensis (Jojoba) seed oil, cetyl alcohol, dimethicone, tetrahexyldecyl ascorbate, Leuconostoc/radish root ferment filtrate, sodium hyaluronate, palmitoyl tripeptide-5, acetyl tetrapeptide-2, hydrogenated lecithin, ubiquinone, tocopheryl acetate, caprylyl glycol, tocopherol, citric acid, potassium sorbate, squalane, glyceryl stearate, polyacrylate crosspolymer-6, and tbutyl alcohol. Trophikos Vaginal Moisturizer is packaged in 30 mL airless bottles made of styrene-acrylonitrile, with a piston made of polyethylene, and an aluminum base. Trophikos Vaginal Moisturizer is a personal lubricant with over-the-counter (OTC) use.
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