# K042256: IR Heat Lamp Systems: Icl 15 HFPL System, Icl 60 Plus HFPL System (Models 40, 100 and 250), Icl 100 Activo Scanner Syste

- Pathway: 510(k) (Traditional)
- Applicant: Usa Laser Biotech, Inc.
- Decided: Nov 17, 2004 after 89 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: 2 generations back to K001179 (2000). 2 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001179: Super Nova, Acubeam, Light Force Therapy, Inc. (2000) Summary page 1.
- K023621: Bioflex Professional Therapy System, Meditech International, Inc. (2003) Summary page 1.

## Most influential descendants
- K101893: Nexus Biowave 7W Lite IR Lamp System, Nexus Biowave 10W Lite IR Lamp System, Nexus Biowave 30W Pro IR Lamp System, Nexus (2011), 5 descendants of its own
- K132016: Lumix 3 Plus and Lumix 3 Ultra System (2014), 3 descendants of its own
- K171087: AXON IR Heat Lamp (2017), 0 descendants of its own
- K161198: Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 (2016), 0 descendants of its own
- K160947: LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX CPS 4 IR Lamp System LUMIX CPS 5 IR Lamp System (2016), 0 descendants of its own

## Indications for use
The ICL IR Heat Lamp Systems, as listed above, are intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and / or the temporary relaxation of muscle.

Source page: https://510kreport.com/device/K042256
Methodology: https://510kreport.com/methodology