# K050370: Palomar Luxir Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Palomar Medical Technologies, Inc.
- Decided: Jun 15, 2005 after 121 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: 4 generations back to K871179 (1987). 17 ancestors in all.
239 later devices descend from it; 3 cite it directly.
0 of 257 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033768: Altus Medical Optional Infrared Handpiece, Altus Medical, Inc. (2004) Summary page 1.

## Most influential descendants
- K080318: Alma Laser Nir Module (2008), 184 descendants of its own
- K102716: Modified Alma Lasers Family of Soprano XL Multi-Application Platmforms (2010), 124 descendants of its own
- K112031: Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with the Family of Soprano XL Multi-Application (2011), 118 descendants of its own
- K070298: Modification to Palomar Luxir Handpiece (2007), 64 descendants of its own
- K083595: Ezlase (2009), 58 descendants of its own

## Indications for use
The Palomar LuxlR Handpiece is intended to provide topical heating for the purpose of elevating tissue temperature for 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 the relaxation of muscles. In addition, the Palomar LuxlR Handpiece may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

Source page: https://510kreport.com/device/K050370
Methodology: https://510kreport.com/methodology