FDA 510(k)

Hope&Her Vaginal Dilators

K-Number: K222492 · 2023-06-27

Decision Date2023-06-27

Product CodeHDX

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Hope&Her Vaginal Dilators is the device name listed in this FDA 510(k) record. The listed applicant is Lujena, Inc.. It received FDA 510(k) clearance on 2023-06-27 under 510(k) 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. The listed applicant is Lujena, Inc.. The 510(k) number is K222492.

When did Hope&Her Vaginal Dilators receive FDA 510(k) clearance?

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

Who is the listed applicant for Hope&Her Vaginal Dilators?

The FDA 510(k) record lists Lujena, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Lujena, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233689Hope&Her Vaginal Dilators

Related Devices (Code: HDX)

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

Official Source

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