LUMINA 1600, 3300 AND 6600 SYSTEMS— 510(k) K052814

Substantially Equivalent

Usa Laser Biotech, Inc.

FDA 510(k) clearance K052814 for LUMINA 1600, 3300 AND 6600 SYSTEMS, Substantially Equivalent on 2005-11-30. Applicant: Usa Laser Biotech, Inc..

Clearance details

Applicant: Usa Laser Biotech, Inc.
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 2005-10-04
Decision date: 2005-11-30
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.