510(k) Report

FDA applicant

Lighthouse Medical, Inc.

Waltham, MA4 decisions1995–19960 recalls

FDA records 4 decisions for Lighthouse Medical, Inc. (Waltham, MA) from 1995 to 1996: 4 510(k) clearances. Most are in product codes FDX (Endoscopic Cytology Brush) and FDI (Snare, Flexible). 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Lighthouse Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Lighthouse Medical, 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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Other applicant names beginning “Lighthouse”

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