Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom)

Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom) is an FDA 510(k)-cleared medical device (K153389) manufactured by In Light Wellness Systems, Inc.. This device is classified under the Physical Medicine specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 29, 2016. Regulation: 8.