510(k) Report

FDA applicant

Polydev, Ltd.

Collon, IE3 decisions2016–20170 recalls

FDA records 3 decisions for Polydev, Ltd. (Collon, IE) from 2016 to 2017: 3 510(k) clearances. All are in product code LPL (Lenses, Soft Contact, Daily Wear). Since 2016 its 510(k)s took a median of 90 days from receipt to decision, against 112 for FDA’s reviews in the same codes and years. 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 Polydev, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2016: 22017: 1
2016high 2 (2016) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Polydev, Ltd. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LPLLenses, Soft Contact, Daily Wear3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 90 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 112 days; 3 of its 3 were faster than that.

What has FDA decided for it lately?

  • K171157PolyDev Soft Contact LensesPolydev, Ltd. · 2017
  • K161931Toricolors (hioxifilcon D) Soft Contact LensesPolydev, Ltd. · 2016
  • K160977PolyDev Soft Contact LensesPolydev, Ltd. · 2016

All 3 as Polydev, Ltd. →