# K070298: Modification to Palomar Luxir Handpiece

- Pathway: 510(k) (Special)
- Applicant: Palomar Medical Technologies, Inc.
- Decided: Jul 3, 2007 after 153 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K871179 (1987). 27 ancestors in all.
64 later devices descend from it; 2 cite it directly.
0 of 92 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060069: Palomar Luxir Fractional Handpiece, Palomar Medical Technologies, Inc. (2006) Summary page 1.
- K050370: Palomar Luxir Handpiece, Palomar Medical Technologies, Inc. (2005) Summary page 1.

## Most influential descendants
- K110907: Palomar Icon (TM) Aesthetic System (2011), 57 descendants of its own
- K130028: Resurfx 1565NM Laser Module (2013), 41 descendants of its own
- K142860: Lumenis M22 System (2015), 38 descendants of its own
- K170060: M22 and ResurFx Systems (2017), 24 descendants of its own
- K142376: Palomar Icon Aesthetic System (2014), 13 descendants of its own

## Indications for use
The LuxIR Handpiece is intended for: Photocoagulation of soft tissue in dermatologic applications. 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, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

Source page: https://510kreport.com/device/K070298
Methodology: https://510kreport.com/methodology