K222492 is an FDA 510(k) clearance for the Hope&Her Vaginal Dilators. This device is classified as a Dilator, Vaginal (Class II - Special Controls, product code HDX).
Submitted by Lujena, Inc. (El Cajon, US). The FDA issued a Cleared decision on June 27, 2023, 314 days after receiving the submission on August 17, 2022.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.3900.
| 510(k) Number | K222492 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 17, 2022 |
| Decision Date | June 27, 2023 |
| Days to Decision | 314 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HDX - Dilator, Vaginal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.3900 |