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510(k) Data Aggregation
K Number
K213220Device Name
Revaree Plus Vaginal Suppositories
Manufacturer
Date Cleared
2022-06-21
(265 days)
Product Code
Regulation Number
884.5300Why 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
K153372Device Name
Repagyn vaginal suppositories
Manufacturer
Date Cleared
2016-06-30
(220 days)
Product Code
Regulation Number
884.5300Why 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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