# K153389: Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom)

- Pathway: 510(k) (Traditional)
- Applicant: In Light Wellness Systems, Inc.
- Decided: Mar 30, 2016 after 128 days
- Product code: ILY (Lamp, Infrared, Therapeutic Heating)
- Device class: 2
- Regulation: 21 CFR 890.5500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K931261 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101894: Healthlight Microcontroller, Minipro, Proneurolight, and Pro Unit, Bioremedi Therapeutic Systems, Inc. (2011) Summary page 4.

## Recalls of this device
- Jun 4, 2019 · Class III · Z-1943-2021: LED pads with cord connectors that have v-shaped notches may not have been assembled properly. This issue could lead to a power interruption, causing the controller and power supply to shut down.

## Indications for use
To: 1) temporarily relieve minor pain, stiffness and muscle spasms; and 2) temporarily increase the local blood circulation.

Source page: https://510kreport.com/device/K153389
Methodology: https://510kreport.com/methodology