FDA applicant

Paragon Vision Sciences

Mesa, AZ16 decisions1994–20230 recalls

FDA records 16 decisions for Paragon Vision Sciences (Mesa, AZ) from 1994 to 2023: 16 510(k) clearances. Most are in product codes HQD (Lens, Contact (Other Material) - Daily) and LRX (Case, Contact Lens). Its devices cite 13 predicates, 5 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Paragon Vision Sciences, Inc.”.

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 Paragon Vision Sciences’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Paragon Vision Sciences’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

Other applicant names beginning “Paragon”

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

Paragon 28, Inc. 61 Paragon Trade Brands, Inc. 14 Paragon Diagnostics, Inc. 7 Paragon Medical 5 Paragon Implant Mfg., LLC 5 Paragon Optical Co. 2 Paragon Medical and Scientific, Inc. 1 Paragon Bioteck, Inc. 1

Paragon Vision Sciences

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Paragon”