# Lujena, Inc.

- Location (FDA's records): El Cajon, CA
- FDA decisions: 2 (2023–2024): 2 510(k) clearances
- Product codes: HDX (2)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Owen Mumford USA, Inc.: 1 (https://510kreport.com/company/owen-mumford-usa)

## Recent decisions
- K233689: Hope&Her Vaginal Dilators (May 2, 2024)
- K222492: Hope&Her Vaginal Dilators (Jun 27, 2023)

Source page: https://510kreport.com/company/lujena