# 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

- Pathway: 510(k) (Traditional)
- Applicant: Usa Laser Biotech, Inc.
- Decided: Jul 5, 2016 after 91 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: 17 generations back to K943450 (1995). 125 ancestors in all.
No later device cites it as a predicate yet.
0 of 126 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.
- K123971: Cynosure 1064NM Diode Laser, Cynosure, Inc. (2013) Summary page 5.
- K120604: K-Laser, Eltech S.R.L (2012) Summary page 5.

## Indications for use
The LUMIX CPS Series IR Lamp Systems are intended to emit energy in the visible and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief 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/K160947
Methodology: https://510kreport.com/methodology