510(k) Report

FDA applicant

Novavision, Inc.

Morrisville, NC3 decisions1996–20030 recalls

FDA records 3 decisions for Novavision, Inc. (Morrisville, NC) from 1996 to 2003: 3 510(k) clearances. Most are in product codes HQD (Lens, Contact (Other Material) - Daily) and HPT (Perimeter, Automatic, Ac-Powered). Its devices cite 2 predicates, 0 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 Novavision, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Novavision, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Novavision, 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?

  • HQDLens, Contact (Other Material) - Daily2decisions
  • HPTPerimeter, Automatic, Ac-Powered1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K023623Novavision, Model 2.0Novavision, Inc. · 2003
  • K960584Novanew Reconditioning System for Prof. Use in-Office Use OnlyNovavision, Inc. · 1996
  • K955900Novalens/Novawet Sphjerical & Perception & Vanguard Multifocal &/or Bifocal (Rosifocon a) Rigid Gas…Novavision, Inc. · 1996

All 3 as Novavision, Inc. →