# K152087: HeatLux Pro II

- Pathway: 510(k) (Traditional)
- Applicant: Home Skinovations, Ltd.
- Decided: Jul 29, 2016 after 368 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: 15 generations back to K943450 (1995). 73 ancestors in all.
No later device cites it as a predicate yet.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122579: Velashape, Syneron Medical, Ltd. (2012) Summary page 4.
- K150175: HeatLux Pro I, Home Skinovations, Ltd. (2015) Summary page 4.

## Indications for use
HeatLux Pro II is an over the counter hand held device intended to emit energy in the visible, near IR, and RF spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscular and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and temporary relaxation of muscles.

Source page: https://510kreport.com/device/K152087
Methodology: https://510kreport.com/methodology