# K132529: Gallieon-1 Medical Laser

- Pathway: 510(k) (Traditional)
- Applicant: Future Device and Technology, Inc.
- Decided: May 12, 2014 after 273 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: 6 generations back to K001179 (2000). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031612: Alt Laser, Model VTR 75, Avicenna Laser Technology, Inc. (2003) Summary page 1.
- K050070: K-Laser, Models 3,4,4D,6D, Eltech S.R.L (2005) Summary page 1.
- K083560: Expanded Spectrum Photo Therapy Device, Model Espt-3X, Lighthouse Technical Innovations, Inc. (2008) Summary page 1.

## Indications for use
The device is indicated for emitting 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 arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation.

Source page: https://510kreport.com/device/K132529
Methodology: https://510kreport.com/methodology