510(k) K153389— Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom)

Substantially Equivalent

In Light Wellness Systems, Inc.

Clearance details

Applicant: In Light Wellness Systems, Inc.
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 2015-11-23
Decision date: 2016-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Albuquerque, NM, 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.