BIOLIGHT BIODYNAM— 510(k) K130866

Substantially Equivalent

Biolight AB

FDA 510(k) clearance K130866 for BIOLIGHT BIODYNAM, Substantially Equivalent on 2013-10-25. Applicant: Biolight AB.

Clearance details

Applicant: Biolight AB
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 2013-03-28
Decision date: 2013-10-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Stockholm, SE

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.