# K113668: Healite II System

- Pathway: 510(k) (Traditional)
- Applicant: Lutronic Corporation
- Decided: Jun 19, 2012 after 189 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
Longest line of descent: 3 generations back to K974468 (1998). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043317: Omnilux Plus, Photo Therapeutics Limited (2005) Summary page 1.

## Indications for use
The HEALITE 11 is intended for the following: For use in temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue and to temporarily increase local blood circulation where applied.

Source page: https://510kreport.com/device/K113668
Methodology: https://510kreport.com/methodology