FDA applicant

Ellex Medical Pty, Ltd.

Adelaide, South Australia, AU13 decisions1997–20224 recalls

FDA records 13 decisions for Ellex Medical Pty, Ltd. (Adelaide, South Australia, AU) from 1997 to 2022: 13 510(k) clearances. Most are in product codes HQF (Laser, Ophthalmic) and GEX (Powered Laser Surgical Instrument). Its devices cite 4 predicates, 4 of them its own earlier devices. 4 recalls are linked to its devices.

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

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Ellex Medical Pty, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2007high 2 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2023

2007high 2 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Ellex Medical Pty, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ellex Medical Pty, Ltd.’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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Other applicant names beginning “Ellex”

FDA records each applicant name separately; these may or may not be the same firm.

Ellex, Inc. 2

Ellex Medical Pty, Ltd.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Ellex”