CARBON DIOXIDE LASER SYSTEM MODEL 20-CX W/ATTACH.— 510(k) K883738

Substantially Equivalent

Directed Energy, Inc.

FDA 510(k) clearance K883738 for CARBON DIOXIDE LASER SYSTEM MODEL 20-CX W/ATTACH., Substantially Equivalent on 1988-11-15. Applicant: Directed Energy, Inc..

Clearance details

Applicant: Directed Energy, Inc.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 1988-09-01
Decision date: 1988-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

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.