XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBP— 510(k) K022384

Substantially Equivalent

Isolux America

FDA 510(k) clearance K022384 for XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBP, Substantially Equivalent on 2002-10-18. Applicant: Isolux America.

Clearance details

Applicant: Isolux America
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 2002-07-22
Decision date: 2002-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HET

product code HET

Malfunction: 10,504
Total: 10,504

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.