510(k) Report

FDA applicant

Innova Vision, Inc.

Flagstaff, AZ11 decisions2004–20240 recalls

FDA records 11 decisions for Innova Vision, Inc. (Flagstaff, AZ) from 2004 to 2024: 11 510(k) clearances. Most are in product codes LPL (Lenses, Soft Contact, Daily Wear) and MVN (Lens, Contact, (Disposable)). Since 2016 its 510(k)s took a median of 144 days from receipt to decision, against 167 for FDA’s reviews in the same codes and years. Its devices cite 19 predicates, 11 of them its own earlier devices. 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 Innova Vision, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2007: 22009: 12012: 12022: 12023: 22024: 1
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Innova Vision, 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 Wear9decisions
  • MVNLens, Contact, (Disposable)2decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 144 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 167 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 19 predicates; 11 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 15 times; 11 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.

  • K213119Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact LensInnova Vision, Inc. · 20224cite it
  • K051129Discon (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily WearInnova Vision, Inc. · 20053cite it
  • K083288Discon Plus (Etafilcon a) Contact Lens Visibility Tint with UV BlockerInnova Vision, Inc. · 20092cite it
  • K033136I-Lux Innova Blue Tint Lens, Model Super O2Innova Vision, Inc. · 20042cite it
  • K232139Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact LensInnova Vision, Inc. · 20231cites it
  • K222954Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact LensInnova Vision, Inc. · 20231cites it

What has FDA decided for it lately?

  • K240519Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact LensInnova Vision, Inc. · 2024
  • K232139Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact LensInnova Vision, Inc. · 2023
  • K222954Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact LensInnova Vision, Inc. · 2023
  • K213119Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact LensInnova Vision, Inc. · 2022
  • K112373Calaview Color (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear ModificationInnova Vision, Inc. · 2012
  • K083288Discon Plus (Etafilcon a) Contact Lens Visibility Tint with UV BlockerInnova Vision, Inc. · 2009
  • K073060Calaview (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily WearInnova Vision, Inc. · 2007
  • K062541Calaview Colors (Etafilcon a) Soft (Hydrophilic) Contact LensInnova Vision, Inc. · 2007

All 11 as Innova Vision, Inc. →

Other applicant names beginning “Innova”

FDA records each applicant name separately; these may or may not be the same firm.

Innova Corp. 6Innova Life Sciences Corp. 4Innova Spinal Technologies, LLC 2Innova Vascular, Inc. 1