Hope&Her Vaginal Dilators— 510(k) K222492

Substantially Equivalent

Lujena, Inc.

FDA 510(k) clearance K222492 for Hope&Her Vaginal Dilators, Substantially Equivalent on 2023-06-27. Applicant: Lujena, Inc..

Clearance details

Applicant: Lujena, Inc.
Product code: Code HDX
Advisory panel: Obstetrics/Gynecology
Date received: 2022-08-17
Decision date: 2023-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: El Cajon, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HDX

product code HDX

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.