FDA applicant

Isolux America

Naples, FL3 decisions1999–20020 recalls

FDA records 3 decisions for Isolux America (Naples, FL) from 1999 to 2002: 3 510(k) clearances. Most are in product codes FST (Light, Surgical, Fiberoptic) and HBI (Illuminator, Fiberoptic, Surgical Field). 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 Isolux America’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Isolux America since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Isolux”

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

Isolux, LLC 3

Isolux America

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Isolux”