OMNILIGHT VL-2004, PL-2004, DL-2004, AND WL-2004— 510(k) K040664

Substantially Equivalent

Omnilight, Inc.

FDA 510(k) clearance K040664 for OMNILIGHT VL-2004, PL-2004, DL-2004, AND WL-2004, Substantially Equivalent on 2004-05-28. Applicant: Omnilight, Inc..

Clearance details

Applicant: Omnilight, Inc.
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 2004-03-10
Decision date: 2004-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Placitas,, NM, 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.