FDA applicant

Soflex Limited

Littleton, CO3 decisions2011–20130 recalls

FDA records 3 decisions for Soflex Limited (Littleton, CO) from 2011 to 2013: 3 510(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 Soflex Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2011high 1 (2011) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Soflex Limited by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Soflex”

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

Soflex Contact Lens Industries, Ltd. 6 Soflex Isralens Contact Lens, Ltd. 1

Soflex Limited

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?

Other applicant names beginning “Soflex”