510(k) Report

FDA applicant

Bescon Co., Ltd.

Grand Junction, CO2 decisions2001–20012 recalls

FDA records 2 decisions for Bescon Co., Ltd. (Grand Junction, CO) in 2001: 2 510(k) clearances. All are in product code LPL (Lenses, Soft Contact, Daily Wear). 2 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 Bescon Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bescon Co., Ltd. since 2007.

Recalls per year

2in 2011

2011: 2
2007high 2 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Bescon Co., Ltd. by year, 2007–2026Sources: 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 Wear2decisions

What has FDA decided for it lately?

  • K001962S45 (Ocufilcon a) Spherical, Aspherical, Toric and Multifocal Soft Contact Lens for Daily Wear (Clear and…Bescon Co., Ltd. · 2001
  • K002099S38 (Polymacon) Spherical, Aspherical, Toric and Multifocal Soft Contact Lens for Daily Wear (Clear and…Bescon Co., Ltd. · 20012 recalls

All 2 as Bescon Co., Ltd. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K002099Neulook Deluxe is packaged in a pink soft plastic box with white, black, and rainbow…Dec 5, 2011
  • K002099Neulook Fancy FX is packaged in a small glass bottle with a orange, white, and yellow…Dec 5, 2011