# K171087: AXON IR Heat Lamp

- Pathway: 510(k) (Traditional)
- Applicant: Crystal Medtech, LLC
- Decided: Jul 7, 2017 after 86 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: 8 generations back to K875052 (1988). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132016: Lumix 3 Plus and Lumix 3 Ultra System, Texas Applied Biomedical Services, Inc. (2014) Summary page 5.
- K101893: Nexus Biowave 7W Lite IR Lamp System, Nexus Biowave 10W Lite IR Lamp System, Nexus Biowave 30W Pro IR Lamp System, Nexus, Usa Laser Biotech, Inc. (2011) Summary page 5.
- K120604: K-Laser, Eltech S.R.L (2012) Summary page 5.

## Indications for use
The AXON IR Heat Lamp System is 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/K171087
Methodology: https://510kreport.com/methodology