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

- Pathway: 510(k) (Traditional)
- Applicant: Healthlight, LLC
- Decided: Jun 13, 2017 after 222 days
- Product code: ILY (Lamp, Infrared, Therapeutic Heating)
- Device class: 2
- Regulation: 21 CFR 890.5500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Intended for the relaxation of muscles and relief from muscle spasms, temporary relief of minor muscle and joint aches, pain and stiffness, temporarily relief of minor pain and stiffness associated with arthritis, and to temporarily increase local blood circulation. The HealthLight Footbed Model HL-FB is specifically indicated for treatment of the feet and lower legs.

Source page: https://510kreport.com/device/K163079
Methodology: https://510kreport.com/methodology