ASA LASER SH1— 510(k) K122125

Substantially Equivalent

El.En Electronic Engineering Spa

FDA 510(k) clearance K122125 for ASA LASER SH1, Substantially Equivalent on 2013-01-25. Applicant: El.En Electronic Engineering Spa.

Clearance details

Applicant: El.En Electronic Engineering Spa
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 2012-07-18
Decision date: 2013-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Calenzano, IT

Download summary PDF View on FDA.gov ↗

Adverse events under product code ILY

product code ILY

Death: 3
Total: 3

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.