Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Hope&Her Vaginal Dilators

K-Number: K233689 · 2024-05-02

ApplicantLujena, Inc.
Decision Date2024-05-02
Product CodeHDX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Hope&Her Vaginal Dilators is a medical device manufactured by Lujena, Inc.. It received FDA 510(k) clearance on 2024-05-02 under approval number K233689. The device is classified under product code HDX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hope&Her Vaginal Dilators?

Hope&Her Vaginal Dilators is a medical device that received FDA 510(k) clearance on 2024-05-02. It is manufactured by Lujena, Inc.. The 510(k) number is K233689.

When was Hope&Her Vaginal Dilators approved by the FDA?

Hope&Her Vaginal Dilators received FDA 510(k) clearance on 2024-05-02, under approval number K233689.

What company makes Hope&Her Vaginal Dilators?

Hope&Her Vaginal Dilators is manufactured by Lujena, Inc..

What is the FDA product code for Hope&Her Vaginal Dilators?

The FDA product code for Hope&Her Vaginal Dilators is HDX.

Other Devices by Lujena, Inc.

K222492Hope&Her Vaginal Dilators

Related Devices (Code: HDX)

K211959Milli Vaginal DilatorMaterna Medical K222492Hope&Her Vaginal DilatorsLujena, Inc. K231430Intimate Rose Vaginal DilatorsPlus EV Holdings Dba Intimate Rose K220035Milli Vaginal DilatorMaterna Medical K241748Intimate Rose Vaginal DilatorsPlus EV Holdings Dba Intimate Rose

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑