510(k) Report

FDA applicant

Azena Medical, LLC

Walnut Creek, CA4 decisions2015–20260 recalls

FDA records 4 decisions for Azena Medical, LLC (Walnut Creek, CA) from 2015 to 2026: 4 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and NVK (Laser, Dental, Soft Tissue). Its devices cite 5 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Azena Medical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2015: 12020: 12021: 12026 (partial year): 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Azena Medical, LLC by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Azena Medical, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GEXPowered Laser Surgical Instrument2decisions
  • NVKLaser, Dental, Soft Tissue2decisions

Whose devices does it build on?

Its devices cite 5 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K152032ELUMI 810 + 980 Soft Tissue LaserAzena Medical, LLC · 20153cite it
  • K192617Gemini 810+980 Soft Tissue LaserAzena Medical, LLC · 20201cites it
  • K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC · 20211cites it

What has FDA decided for it lately?

  • K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC · 2026
  • K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC · 2021
  • K192617Gemini 810+980 Soft Tissue LaserAzena Medical, LLC · 2020
  • K152032ELUMI 810 + 980 Soft Tissue LaserAzena Medical, LLC · 2015

All 4 as Azena Medical, LLC →