510(k) K091497— K-LASER K-1200, MODEL 12 W

Substantially Equivalent

Eltech S.R.L

Clearance details

Applicant: Eltech S.R.L
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 2009-05-20
Decision date: 2009-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin, TN, US

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.