Azena Medical
Walnut Creek, CA, US
AZENA MEDICAL appears in FDA device records in Walnut Creek, CA. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Azena Medical between 2015 and 2026. The busiest year on record is 2015, with 1. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2015 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260765 | Gemini NOVA 810+980 Soft Tissue Laser | NVK | Substantially Equivalent | |
| K210350 | Gemini 2 810+980 Soft Tissue Laser | NVK | Substantially Equivalent | |
| K192617 | Gemini 810+980 Soft Tissue Laser | GEX | Substantially Equivalent | |
| K152032 | ELUMI 810 + 980 Soft Tissue Laser | GEX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3011877721 | 3011877721 | AZENA MEDICAL | 1777 Botelho Dr Ste 100, Walnut Creek, CA 94596 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain