# Azena Medical, LLC

- Location (FDA's records): Walnut Creek, CA
- FDA decisions: 4 (2015–2026): 4 510(k) clearances
- Product codes: GEX (2), NVK (2)
- Predicates its devices cite: 5 (3 its own); citations of its devices by later devices: 5 (3 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
- Quicklase Limited: 1 (https://510kreport.com/company/quicklase)
- Biolase, Inc.: 1 (https://510kreport.com/company/biolase)

## Firms that cite its devices most
- Biolase, Inc.: 1 (https://510kreport.com/company/biolase)
- Medency S.R.L.: 1 (https://510kreport.com/company/medency)

## Its most-cited devices
- K152032: ELUMI 810 + 980 Soft Tissue Laser (2015), cited by 3
- K192617: Gemini 810+980 Soft Tissue Laser (2020), cited by 1
- K210350: Gemini 2 810+980 Soft Tissue Laser (2021), cited by 1

## Recent decisions
- K260765: Gemini NOVA 810+980 Soft Tissue Laser (Mar 10, 2026)
- K210350: Gemini 2 810+980 Soft Tissue Laser (Nov 18, 2021)
- K192617: Gemini 810+980 Soft Tissue Laser (Feb 20, 2020)
- K152032: ELUMI 810 + 980 Soft Tissue Laser (Sep 16, 2015)

Source page: https://510kreport.com/company/azena-medical