MULTIPLE CO2 LAERS— 510(k) K941838

Substantially Equivalent

Mattioli Engineering, Srl

FDA 510(k) clearance K941838 for MULTIPLE CO2 LAERS, Substantially Equivalent on 1994-12-15. Applicant: Mattioli Engineering, Srl.

Clearance details

Applicant: Mattioli Engineering, Srl
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 1994-04-13
Decision date: 1994-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Florence, IT

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.