510(k) Report

FDA applicant

Eltech S.R.L

Franklin, TN3 decisions2005–20120 recalls

FDA records 3 decisions for Eltech S.R.L (Franklin, TN) from 2005 to 2012: 3 510(k) clearances. All are in product code ILY (Lamp, Infrared, Therapeutic Heating). Its devices cite 7 predicates, 2 of them its own earlier devices. 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 Eltech S.R.L’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2009: 12012: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Eltech S.R.L’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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Which product codes does it file in?

  • ILYLamp, Infrared, Therapeutic Heating3decisions

Whose devices does it build on?

Its devices cite 7 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 12 times; 2 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.

  • K050070K-Laser, Models 3,4,4D,6DEltech S.R.L · 20055cite it
  • K120604K-LaserEltech S.R.L · 20124cite it
  • K091497K-Laser K-1200, Model 12 WEltech S.R.L · 20093cite it

What has FDA decided for it lately?

  • K120604K-LaserEltech S.R.L · 2012
  • K091497K-Laser K-1200, Model 12 WEltech S.R.L · 2009
  • K050070K-Laser, Models 3,4,4D,6DEltech S.R.L · 2005

All 3 as Eltech S.R.L →