FDA applicant

Notal Vision, Inc.

Rockville, MD4 decisions2002–20240 recalls

FDA records 4 decisions for Notal Vision, Inc. (Rockville, MD) from 2002 to 2024: 3 510(k) clearances and 1 De Novo grant. Most are in product codes HPT (Perimeter, Automatic, Ac-Powered) and HOQ (Grid, Amsler). Its devices cite 8 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Notal Vision , Ltd.”.

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 Notal Vision, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Notal Vision, Inc.

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?