# K061080: IR PRO 250

- Pathway: 510(k) (Traditional)
- Applicant: Lhasa Oms, Inc.
- Decided: Jun 14, 2006 after 57 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: 1 generation back to K003538 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003538: TDP CQ-27 Heat Lamp, Lhasa Medical, Inc. (2001) Summary page 1.

## Indications for use
The IR Pro 250 is intended for use in the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and relaxation of muscles. In addition, the lamp may help muscle spasms, minor sprains and strains, and minor back pain.

Source page: https://510kreport.com/device/K061080
Methodology: https://510kreport.com/methodology