CS1000 LIGHT THERAPY DEVICE— 510(k) K110558

Substantially Equivalent

Genesis Health Light Corporation

FDA 510(k) clearance K110558 for CS1000 LIGHT THERAPY DEVICE, Substantially Equivalent on 2012-07-12. Applicant: Genesis Health Light Corporation.

Clearance details

Applicant: Genesis Health Light Corporation
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 2011-02-28
Decision date: 2012-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hamilton, Ontario, CA

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.