510(k) Report

FDA applicant

Precision Healing, LLC

Fort Worth, TX1 decision2023–20230 recalls

FDA records 1 decision for Precision Healing, LLC (Fort Worth, TX) in 2023: 1 510(k) clearance. All are in product code QJF (Autofluorescence Imaging Adjunct Tool For Wounds). 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, general and plastic surgery panel, where it files most

How often FDA has decided Precision Healing, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2023: 1
2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Precision Healing, LLC by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QJFAutofluorescence Imaging Adjunct Tool For Wounds1decision

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?

  • K230734Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009)Precision Healing, LLC · 2023

The one decision as Precision Healing, LLC →