# K120582: Heatlux

- Pathway: 510(k) (Traditional)
- Applicant: Home Skinovations, Ltd.
- Decided: Jul 6, 2012 after 130 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: 5 generations back to K974468 (1998). 14 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032229: Quantum Warp 10 Light Delivery System, Quantum Devices, Inc. (2003) Summary page 1.
- K101716: HVR Pain Relief Device, H.V.R., Inc. (2011) Summary page 1.
- K090008: Tanda Restore, Model Ptscs, Pharos Life Corporation (2009) Summary page 1.
- K083580: Anti-Wrinkle Light, Model 1302 and Pain Therapy Light, Model 1301, Led Intellectual Properties, LLC (2009) Summary page 1.

## Most influential descendants
- K150175: HeatLux Pro I (2015), 1 descendant of its own
- K162763: Vevazz LED Heat Lamp (2017), 0 descendants of its own
- K152087: HeatLux Pro II (2016), 0 descendants of its own

## Indications for use
HeatLux is over the counter hand held device intended to emit energy in the visible and near 1k spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscular and joint pain and stiffniess, minor arthritis pain or muscle spasm, the temporary increase in local and blood circulation, and temporary relaxation of muscles.

Source page: https://510kreport.com/device/K120582
Methodology: https://510kreport.com/methodology