Data / Medical devices / United States / Azena Medical
Azena Medical: FDA-registered device maker in Walnut Creek, CA, United States, 4 510(k) clearances
Azena Medical is registered with the FDA (registration 3011877721) in Walnut Creek, CA, United States. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated March 10, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011877721
- Address
- 1777 Botelho Dr Ste 100, Walnut Creek, CA, United States, 94596
- Owner or operator
- Azena Medical (10051175)
- Roles
- Manufacturer, Specification developer
- First device listed
- February 11, 2016
- Registered through
- 2026
- Brand names listed
- Gemini 810+980 Soft Tissue Laser, Gemini Diode Laser, Gemini EVO, Gemini NOVA
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Laser, Dental, Soft Tissue | NVK | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 10, 2026 | K260765 | Gemini NOVA 810+980 Soft Tissue Laser | NVK | Substantially Equivalent | Azena Medical, LLC | accessdata.fda.gov |
| November 18, 2021 | K210350 | Gemini 2 810+980 Soft Tissue Laser | NVK | Substantially Equivalent | Azena Medical, LLC | accessdata.fda.gov |
| February 20, 2020 | K192617 | Gemini 810+980 Soft Tissue Laser | GEX | Substantially Equivalent | Azena Medical, LLC | accessdata.fda.gov |
| September 16, 2015 | K152032 | ELUMI 810 + 980 Soft Tissue Laser | GEX | Substantially Equivalent | Azena Medical, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Laser Surgical Instrument
- All makers of Laser, Dental, Soft Tissue
- All makers of Lamp, Infrared, Therapeutic Heating
Updated March 10, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.