510(k) Report

FDA applicant

Del Mar Technologies, Inc.

San Diego, CA1 decision1999–19990 recalls

FDA records 1 decision for Del Mar Technologies, Inc. (San Diego, CA) in 1999: 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 Del Mar Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Del Mar Technologies, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Del Mar Technologies, Inc. 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?

  • 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.

  • K984339Medart 455 Scanner SystemDel Mar Technologies, Inc. · 19991cites it

What has FDA decided for it lately?

  • K984339Medart 455 Scanner SystemDel Mar Technologies, Inc. · 1999

The one decision as Del Mar Technologies, Inc. →