K123385

Substantially Equivalent

MEDILAS H LASER FIBERS

Applicant: Dornier Medtech America, Inc.
Product code: GEX
Advisory panel: General, Plastic Surgery
Date received: 2012-11-02
Decision date: 2012-12-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Kennesaw, GA, US

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.