510(k) Report

FDA applicant

Mi Gwang Contact Lens Co., Ltd.

Grand Junction, CO1 decision2006–20061 recall

FDA records 1 decision for Mi Gwang Contact Lens Co., Ltd. (Grand Junction, CO) in 2006: 1 510(k) clearance. All are in product code LPL (Lenses, Soft Contact, Daily Wear). 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 Mi Gwang Contact Lens Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mi Gwang Contact Lens Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Mi Gwang Contact Lens Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Mi Gwang Contact Lens Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • LPLLenses, Soft Contact, Daily Wear1decision

Who builds on its devices?

Later devices cite its devices 5 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K051477Migwang Comfort 38 (Polymacon) Spherical and Toric Soft Contact Lens for Daily Wear (Clear, Tinted and…Mi Gwang Contact Lens Co., Ltd. · 20065cite it

What has FDA decided for it lately?

  • K051477Migwang Comfort 38 (Polymacon) Spherical and Toric Soft Contact Lens for Daily Wear (Clear, Tinted and…Mi Gwang Contact Lens Co., Ltd. · 20061 recall

The one decision as Mi Gwang Contact Lens Co., Ltd. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K051477Soft Cosmetic Contact Lenses sold under the brand names: Circle Lens, Europa, Pacifica…May 10, 2006