FDA applicant

Gelflex

Perth, AU2 decisions2001–20030 recalls

FDA records 2 decisions for Gelflex (Perth, AU) from 2001 to 2003: 2 510(k) clearances. All are in product code LPL (Lenses, Soft Contact, Daily Wear). 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’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gelflex since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Gelflex”

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

Gelflex Laboratories 4

Gelflex

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Gelflex”