Medical Device Manufacturer · US , El Cajon , CA

Lujena, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2023

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Lujena, Inc. Obstetrics & Gynecology ✕

2 devices

1-2 of 2

Cleared May 02, 2024

Hope&Her Vaginal Dilators

Obstetrics & Gynecology · 167d

Cleared Jun 27, 2023

Hope&Her Vaginal Dilators

Obstetrics & Gynecology · 314d

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: May 11, 2026