Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Azena Medical, LLC · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260765 | Gemini NOVA 810+980 Soft Tissue Laser | Azena Medical, LLC | 2026-03-10 | 1 | 0 |
| K210350 | Gemini 2 810+980 Soft Tissue Laser | Azena Medical, LLC | 2021-11-18 | 283 | 0 |
| K192617 | Gemini 810+980 Soft Tissue Laser | Azena Medical, LLC | 2020-02-20 | 150 | 0 |
| K152032 | ELUMI 810 + 980 Soft Tissue Laser | Azena Medical, LLC | 2015-09-16 | 56 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda