MODEL 8A PREVIOUSLY MINI HALO CO2 LASER SYSTEM— 510(k) K854387

Substantially Equivalent

Directed Energy, Inc.

FDA 510(k) clearance K854387 for MODEL 8A PREVIOUSLY MINI HALO CO2 LASER SYSTEM, 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.