510(k) Report

FDA applicant

The See Clear Company, Inc.

Golden, CO1 decision2011–20111 recall

FDA records 1 decision for The See Clear Company, Inc. (Golden, CO) in 2011: 1 510(k) clearance. All are in product code LPL (Lenses, Soft Contact, Daily Wear). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 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 The See Clear Company, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2011: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2017

2017: 1
2011high 1 (2017) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — The See Clear Company, Inc. by year, 2011–2026Sources: 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 Wear1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K111345See Clear Soft Contact Lens, See Clear Color Soft Contact Lens, Fierce Soft Contact LensThe See Clear Company, Inc. · 20111 recall

The one decision as The See Clear Company, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K111345Color contact lenses labeled under the following brands: Diamond, Fierce, Ambition…Jan 6, 2017Class II