510(k) Report

FDA applicant

Diamond Age Systems, Inc.

Chandler, AZ1 decision2004–20040 recalls

FDA records 1 decision for Diamond Age Systems, Inc. (Chandler, AZ) in 2004: 1 510(k) clearance. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 5 predicates, 0 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Diamond Age Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Diamond Age Systems, 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

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K042439Azuryt Model CLT 1401, CO2 Surgical Laser SystemDiamond Age Systems, Inc. · 20041cites it

What has FDA decided for it lately?

  • K042439Azuryt Model CLT 1401, CO2 Surgical Laser SystemDiamond Age Systems, Inc. · 2004

The one decision as Diamond Age Systems, Inc. →

Other applicant names beginning “Diamond”

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

Diamond Diagnostics, Inc. 26Diamond Medical, Inc. 6Diamond Sensor Systems 3Diamond Medical Equipment, Inc. 3Diamond Shamrock Corp. 2Diamond Electro-Tech, Inc. 1Diamond Orthopedic, LLC 1Diamond Rotary and Carbide Intl. 1Diamond Systems USA, Inc. 1Diamond General Development Corp. 1Diamond Orthotic Laboratory 1Diamond Mark International Co., Ltd. 1