510(k) Report

FDA applicant

Lumicell, Inc.

Newton1 decision2024–20241 recall

FDA records 1 decision for Lumicell, Inc. (Newton) in 2024: 1 original PMA approval. All are in product code SAW (Fluorescence Imaging For Breast Cancer Detection). 1 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 Lumicell, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2024: 1
2024high 1 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

1in 2025

2025: 1
2024high 1 (2025) · low 0 (2024)2026

Class I Class II/III not classified

FIG. 1 — Lumicell, Inc. by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • SAWFluorescence Imaging For Breast Cancer Detection1decision

What has FDA decided for it lately?

  • P230014Lumicell Direct Visualization System (DVS)Lumicell, Inc. · 20241 recall

The one decision as Lumicell, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • P230014Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218…Jul 31, 2025Class II