MODEL CO2 LASER SYSTEM 8B— 510(k) K854398

Substantially Equivalent

Directed Energy, Inc.

FDA 510(k) clearance K854398 for MODEL CO2 LASER SYSTEM 8B, Substantially Equivalent on 1986-02-07. Applicant: Directed Energy, Inc..

Clearance details

Applicant: Directed Energy, Inc.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 1985-10-31
Decision date: 1986-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, 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.