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FDA 510(k)

Hope&Her Vaginal Dilators

K-Number: K222492 · 2023-06-27

ApplicantLujena, Inc.
Decision Date2023-06-27
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 2023-06-27 under approval number K222492. 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 2023-06-27. It is manufactured by Lujena, Inc.. The 510(k) number is K222492.

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

Hope&Her Vaginal Dilators received FDA 510(k) clearance on 2023-06-27, under approval number K222492.

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.

K233689Hope&Her Vaginal Dilators

Related Devices (Code: HDX)

K211959Milli Vaginal DilatorMaterna Medical K231430Intimate Rose Vaginal DilatorsPlus EV Holdings Dba Intimate Rose K220035Milli Vaginal DilatorMaterna Medical K241748Intimate Rose Vaginal DilatorsPlus EV Holdings Dba Intimate Rose K233689Hope&Her Vaginal DilatorsLujena, Inc.

Official Source

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