FDA applicant

Gelflex Laboratories

Perth, Western, Wa, AU4 decisions1996–20180 recalls

FDA records 4 decisions for Gelflex Laboratories (Perth, Western, Wa, AU) from 1996 to 2018: 4 510(k) clearances. All are in product code LPL (Lenses, Soft Contact, Daily Wear). Its devices cite 3 predicates, 0 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, ophthalmic panel, where it files most

How often FDA has decided Gelflex Laboratories’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2007high 1 (2018) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Other applicant names beginning “Gelflex”

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

Gelflex 2

Gelflex Laboratories

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Gelflex”