LUMINEX INFRARED LAMP SYSTEM— 510(k) K082969

Substantially Equivalent

Medical Laser Systems, Inc.

FDA 510(k) clearance K082969 for LUMINEX INFRARED LAMP SYSTEM, Substantially Equivalent on 2008-10-23. Applicant: Medical Laser Systems, Inc..

Clearance details

Applicant: Medical Laser Systems, Inc.
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 2008-10-06
Decision date: 2008-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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.