510(k) Report

FDA applicant

X-Cel Contacts, Inc.

Grand Junction, CO2 decisions2007–20100 recalls

FDA records 2 decisions for X-Cel Contacts, Inc. (Grand Junction, CO) from 2007 to 2010: 2 510(k) clearances. All are in product code LPL (Lenses, Soft Contact, Daily Wear). Its devices cite 7 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “X-Cel Contacts”.

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 X-Cel Contacts, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2007: 12010: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — X-Cel Contacts, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like X-Cel Contacts, Inc.’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 Wear2decisions

Whose devices does it build on?

Its devices cite 7 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K100443Definitive, Flexlens - Silicone HydrogelX-Cel Contacts, Inc. · 20101cites it
  • K070308Flexlens Multifocal Soft Contact Lens, (Hioxifilcon a) and (Hioxifilcon B) for Daily WearX-Cel Contacts · 20071cites it

What has FDA decided for it lately?

  • K100443Definitive, Flexlens - Silicone HydrogelX-Cel Contacts, Inc. · 2010
  • K070308Flexlens Multifocal Soft Contact Lens, (Hioxifilcon a) and (Hioxifilcon B) for Daily WearX-Cel Contacts · 2007

The one decision as X-Cel Contacts, Inc. →The one decision as X-Cel Contacts →