HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System— 510(k) K163079

Substantially Equivalent

Healthlight, LLC

FDA 510(k) clearance K163079 for HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System, Substantially Equivalent on 2017-06-13. Applicant: Healthlight, LLC.

Clearance details

Applicant: Healthlight, LLC
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 2016-11-03
Decision date: 2017-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Schaumburg, IL, US

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.