510(k) Report

FDA applicant

Biolight International AB

Minneapolis,, MN1 decision2002–20020 recalls

FDA records 1 decision for Biolight International AB (Minneapolis,, MN) in 2002: 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 Biolight International AB’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biolight International AB since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • ILYLamp, Infrared, Therapeutic Heating1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K011355Biolight PCDBiolight International AB · 20021cites it

What has FDA decided for it lately?

  • K011355Biolight PCDBiolight International AB · 2002

The one decision as Biolight International AB →

Other applicant names beginning “Biolight”

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

Biolight AB 1