# K150466: ZX2 Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Lzr7, Inc.
- Decided: Jun 8, 2015 after 105 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: 7 generations back to K001179 (2000). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060134: Apollo IR Heat Lamp System, Apollo Physical Therapy Products International (2006) Summary page 5.

## Indications for use
The ZX2 Laser 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/K150466
Methodology: https://510kreport.com/methodology