510(k) Report

FDA applicant

Smi

Lakewood, CO1 decision1994–19940 recalls

FDA records 1 decision for Smi (Lakewood, CO) in 1994: 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 Smi’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Smi since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Smi 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 4 times; 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.

  • K931261Spectropad SystemSmi · 19944cite it

What has FDA decided for it lately?

  • K931261Spectropad SystemSmi · 1994

The one decision as Smi →