510(k) K150554— NuBrilliance Light Pain Therapy

Substantially Equivalent

Wellquest International, Inc.

Clearance details

Applicant: Wellquest International, Inc.
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 2015-03-04
Decision date: 2015-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

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.