NEXUS XPULSE 805 IR LAMP SYSTEM, NEXUS XPULSE 980 IR LAMP SYSTEM, MODEL 805, 980— 510(k) K091726

Substantially Equivalent

Usa Laser Biotech, Inc.

FDA 510(k) clearance K091726 for NEXUS XPULSE 805 IR LAMP SYSTEM, NEXUS XPULSE 980 IR LAMP SYSTEM, MODEL 805, 980, Substantially Equivalent on 2009-10-28. Applicant: Usa Laser Biotech, Inc..

Clearance details

Applicant: Usa Laser Biotech, Inc.
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 2009-06-11
Decision date: 2009-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

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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.