FDA applicant

MolecuLight, Inc.

Toronto, CA4 decisions2019–20220 recalls

FDA records 4 decisions for MolecuLight, Inc. (Toronto, CA) from 2019 to 2022: 4 510(k) clearances. All are in product code QJF (Autofluorescence Imaging Adjunct Tool For Wounds). Its devices cite 5 predicates, 4 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, general and plastic surgery panel, where it files most

How often FDA has decided MolecuLight, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2019high 2 (2021) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — MolecuLight, Inc. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like MolecuLight, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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MolecuLight, 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?