# K151521: Phoenix Thera-Lase System

- Pathway: 510(k) (Traditional)
- Applicant: Phoenix Thera-Lase Systems, LLC
- Decided: Sep 4, 2015 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: 8 generations back to K875052 (1988). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120604: K-Laser, Eltech S.R.L (2012) Summary page 4.
- 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 4.
- K122125: Asa Laser SH1, El.En Electronic Engineering Spa (2013) Summary page 4.
- K121363: Diowave Low Level Cold Laser System, Technological Medical Advancments, Inc. (Tma) (2012) Summary page 4.

## Indications for use
The Phoenix Thera-Lase System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with minor arthritis, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation.

Source page: https://510kreport.com/device/K151521
Methodology: https://510kreport.com/methodology