Medical Device Manufacturer · US , Walnut Creek , CA

Azena Medical, LLC - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2015

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Azena Medical, LLC Dental ✕

2 devices

1-2 of 2

Cleared Mar 10, 2026

Gemini NOVA 810+980 Soft Tissue Laser

Cleared Nov 18, 2021

Gemini 2 810+980 Soft Tissue Laser

Data Source

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

Last updated: Apr 27, 2026