FDA applicant

Irradia AB

Newport Beach, CA1 decision2005–20050 recalls

FDA records 1 decision for Irradia AB (Newport Beach, CA) in 2005: 1 510(k) clearance. All are in product code ILY (Lamp, Infrared, Therapeutic Heating). 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, physical medicine panel, where it files most

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

FDA decisions per year

No FDA decision for Irradia AB since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Irradia AB

Which product codes does it file in?

What has FDA decided for it lately?