DEKA SYNCHRO REPLA: Y FAMILY OF LASER SYSTEMS— 510(k) K131095

Substantially Equivalent

El.En Electronic Engineering Spa

FDA 510(k) clearance K131095 for DEKA SYNCHRO REPLA: Y FAMILY OF LASER SYSTEMS, Substantially Equivalent on 2013-12-05. Applicant: El.En Electronic Engineering Spa.

Clearance details

Applicant: El.En Electronic Engineering Spa
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2013-04-18
Decision date: 2013-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Calenzano, 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.