AZURYT MODEL CLT 1401, CO2 SURGICAL LASER SYSTEM— 510(k) K042439

Substantially Equivalent

Diamond Age Systems, Inc.

FDA 510(k) clearance K042439 for AZURYT MODEL CLT 1401, CO2 SURGICAL LASER SYSTEM, Substantially Equivalent on 2004-10-07. Applicant: Diamond Age Systems, Inc..

Clearance details

Applicant: Diamond Age Systems, Inc.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2004-09-09
Decision date: 2004-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chandler, AZ, US

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Adverse events under product code GEX

product code GEX

Death: 33
Injury: 3,045
Malfunction: 12,903
Other: 25
Total: 16,006

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.