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Revaree Plus Vaginal Suppositories
Farma-Derma S.R.L.
Summary: Revaree Plus Vaginal Suppositories are used for vaginal health. Cleared by FDA via 510k pathway. Key evidence includes studies on vaginal progesterone use.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K213220 ↗
Decision Date ?
June 21, 2022
Product Code ?
NUC
Device Class ?
Class 2
Evidence ?
0 studies
Revaree Plus Vaginal Suppositories were cleared by the FDA through the 510k pathway on June 21, 2022. Manufactured by Farma-Derma S.R.L., they are classified as Class 2 under product code NUC.
What It Is
Revaree Plus Vaginal Suppositories are designed to support vaginal health by delivering active ingredients directly to the vaginal mucosa. They are intended for use in managing symptoms related to vaginal atrophy.
FDA-Cleared Indications
- Management of symptoms associated with vaginal atrophy.
- Delivery of the product's active ingredients directly to the vaginal mucosa.
Clinical Applications
- Use in patients with vaginal atrophy.
- Relief of vaginal dryness associated with vaginal atrophy.
- Relief of vaginal irritation associated with vaginal atrophy.
- Use in post-menopausal patients experiencing symptoms of vaginal atrophy.
Evidence Summary
The literature includes 11 studies, with types ranging from randomized controlled trials to case series. The studies span from 2015 to 2024, providing a broad overview of clinical applications.
Reported Outcomes
Published studies report varied outcomes, including the efficacy of vaginal progesterone in supporting luteal phase in IVF cycles. However, specific outcomes related to Revaree Plus are not detailed in the provided evidence.
Safety Profile
Reported complications include common adverse effects associated with vaginal suppositories, such as local irritation. No severe adverse events were highlighted in the provided studies.
Evidence Limitations
The evidence lacks specific studies directly evaluating Revaree Plus. Further research is needed to establish direct efficacy and safety outcomes for this specific device.
Practical Considerations
- This is a vaginal suppository, not an intravascular or implantable device.
- Use the product according to its labeling and clinician instructions, including instructions for insertion, frequency, storage and hygiene.
- Patients with unexplained vaginal bleeding, active vaginal infection, significant pain or an allergy to an ingredient should consult a clinician before use.
- MRI compatibility is not generally applicable because the product is not an implanted or metallic device; any applicator or packaging should be handled according to its labeling.
- Persistent, worsening or new symptoms should be evaluated to confirm the diagnosis and exclude infection, dermatologic disease or other causes.
Frequently Asked Questions
What are the clinical indications for Revaree Plus Vaginal Suppositories?
Revaree Plus is indicated for managing symptoms of vaginal atrophy, such as dryness and irritation, particularly in post-menopausal women.
What outcomes have been reported in clinical studies?
Studies report efficacy in the use of vaginal progesterone for luteal phase support in IVF cycles, but specific outcomes for Revaree Plus are not detailed.
What complications have been reported?
Safety data indicate common adverse effects like local irritation, with no severe complications reported in the studies provided.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.