510(k) Report

FDA applicant

Advanced Vision Research, Inc.

Wilmington, MA1 decision2003–20030 recalls

FDA records 1 decision for Advanced Vision Research, Inc. (Wilmington, MA) in 2003: 1 510(k) clearance. All are in product code LPN (Accessories, Soft Lens Products). 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 Advanced Vision Research, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Advanced Vision Research, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • LPNAccessories, Soft Lens Products1decision

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?

  • K032481Theratears Contact Lens Comfort DropsAdvanced Vision Research, Inc. · 2003

The one decision as Advanced Vision Research, Inc. →