510(k) Report

FDA applicant

Aragona AB Co.

Sweden, SE1 decision1987–19870 recalls

FDA records 1 decision for Aragona AB Co. (Sweden, SE) in 1987: 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 Aragona AB Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Aragona AB Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Aragona AB Co.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

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.

  • K871179Opn Xii ULAragona AB Co. · 19871cites it

What has FDA decided for it lately?

  • K871179Opn Xii ULAragona AB Co. · 1987

The one decision as Aragona AB Co. →

Other applicant names beginning “Aragona”

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

Aragona Medical, Inc. 2