LED LIGHT SOURCE— 510(k) K093792

Substantially Equivalent

Sunoptic Technologies, LLC

FDA 510(k) clearance K093792 for LED LIGHT SOURCE, Substantially Equivalent on 2010-03-18. Applicant: Sunoptic Technologies, LLC.

Clearance details

Applicant: Sunoptic Technologies, LLC
Product code: Code FCW
Advisory panel: Gastroenterology, Urology
Date received: 2009-12-10
Decision date: 2010-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FCW

product code FCW

Malfunction: 912
Other: 1
Total: 913

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.