510(k) Report

FDA applicant

Tollot Pty.Ltd.(Aaxis Pacific)

Littleton, CO1 decision2005–20050 recalls

FDA records 1 decision for Tollot Pty.Ltd.(Aaxis Pacific) (Littleton, CO) in 2005: 1 510(k) clearance. All are in product code LXQ (Cup, Eye). No recall is linked to its devices.

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

How often FDA has decided Tollot Pty.Ltd.(Aaxis Pacific)’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Tollot Pty.Ltd.(Aaxis Pacific) since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Tollot Pty.Ltd.(Aaxis Pacific) by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LXQCup, Eye1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K051414Eye Cup, Sterile 1 and Non SterileTollot Pty.Ltd.(Aaxis Pacific) · 20051cites it

What has FDA decided for it lately?

  • K051414Eye Cup, Sterile 1 and Non SterileTollot Pty.Ltd.(Aaxis Pacific) · 2005

The one decision as Tollot Pty.Ltd.(Aaxis Pacific) →