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510(k) Data Aggregation
K Number
K150883Device Name
HyaloGYN Vaginal Hydrating Gel
Manufacturer
FIDIA FARMACEUTICI SPA
Date Cleared
2015-09-01
(152 days)
Product Code
NUC
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
FIDIA FARMACEUTICI SPA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HyaloGYN® 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 polyisoprene condoms.
Device Description
HyaloGYN is a line extension to add a formulation of HyaloGYN not made with parabens. It is a nonsterile, colorless, odorless, transparent, aqueous, hydrating gel that contains "Hydeal-D®" (a partial benzyl ester of hyaluronic acid), propylene glycol, a carbomer, preservatives and sodium hydroxide (to balance the pH). The hyaluronic acid is manufactured using a bacterial fermentation process.
HyaloGYN is a non-hormonal vaginal moisturizer intended to hydrate the vaginal epithelium because of the strong hydrating properties of its hyaluronic acid derivative component. The carbomer and propylene glycol combine with the hyaluronic acid derivative to enable HyaloGYN to achieve its thick, viscous gel form, and the mucoadhesive properties to allow it to adhere to the vaginal mucosa, enhancing the residence time, thus hydrating this tissue. It is provided in an aluminum tube and packaged together with single-use applicators in a cardboard box. HyaloGYN has a shelf life of 3 years.
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K Number
K094039Device Name
HYALO GYN
Manufacturer
FIDIA FARMACEUTICI SPA
Date Cleared
2010-05-07
(128 days)
Product Code
NUC
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
FIDIA FARMACEUTICI SPA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HYALO GYN is a personal lubricant, for penile and/or 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 condoms: lubricated/non-lubricated latex, lubricated polyurethane, lubricated natural skin.
Device Description
HYALO GYN is a colorless, odorless, transparent, aqueous, hydrating gel that contains "Hydeal-D®" (a partial benzyl ester of hyaluronic acid), propylene glycol, a carbomer, preservatives (methyl-p-hydroxybenzoate and propyl-p-hydroxybenzoate), and sodium hydroxide (to balance the pH). The hyaluronic acid is manufactured using a bacterial fermentation process. HYALO GYN is intended for use as a personal lubricant. HYALO GYN is compatible with latex condoms: lubricated/non-lubricated latex, lubricated polyurethane, lubricated natural skin. HYALO GYN has a pH of 5.5-6.5 and a shelf life of 3 years.
HYALO GYN acts as a moisturizer and lubricant because of the strong hydrating properties of its hyaluronic acid derivative component. The carbomer and propylene glycol, combined with the hyaluronic acid derivative, enable HYALO GYN to achieve its thick, viscous gel form, and the mucoadhesive properties of the product allow it to adhere to the vaginal mucosa, enhancing the residence time, thus hydrating and protecting this tissue.
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