510(k) Report

FDA applicant

Ilt Systems, Inc.

Salt Lake City, UT1 decision1993–19930 recalls

FDA records 1 decision for Ilt Systems, Inc. (Salt Lake City, UT) in 1993: 1 510(k) clearance. All are in product code GEX (Powered Laser Surgical Instrument). 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, general and plastic surgery panel, where it files most

How often FDA has decided Ilt Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ilt Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Ilt Systems, Inc.’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?

  • GEXPowered Laser Surgical Instrument1decision

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.

  • K930210ACL-5500Ilt Systems, Inc. · 19931cites it

What has FDA decided for it lately?

  • K930210ACL-5500Ilt Systems, Inc. · 1993

The one decision as Ilt Systems, Inc. →