# K101506: LUX1540, LUX1440 & LUX2940 Laser Handpieces

- Pathway: 510(k) (Traditional)
- Applicant: Palomar Medical Technologies, Inc.
- Decided: Sep 1, 2010 after 92 days
- Product code: ONG (Powered Laser Surgical Instrument With MicrobeamFractional Output)
- 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: 15 generations back to K910422 (1992). 220 ancestors in all.
156 later devices descend from it; 3 cite it directly.
0 of 377 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100270: Artisan Aesthetic System, Palomar Medical Technologies, Inc. (2010) Summary page 1.
- K083900: Erbium Fractional Handpiece, Palomar Medical Products, Inc. (2009) Summary page 1.
- K071768: Erbium Fractional Handpiece, Palomar Medical Products, Inc. (2007) Summary page 1.
- K071152: Palomar Erbium Handpiece, Palomar Medical Products, Inc. (2007) Summary page 1.
- K063571: Palomar LUX2940 Handpiece, Palomar Medical Technologies, Inc. (2007) Summary page 1.
- K090195: Palomar LUX1540 Handpiece, Palomar Medical Technologies, Inc. (2009) Summary page 1.
- K091446: Modification to LUX1540 Handpiece and Lux 1440 Handpiece, Palomar Medical Products, Inc. (2009) Summary page 1.
- K080244: Palomar Lux 1540 Handpiece, Palomar Medical Products, Inc. (2008) Summary page 1.
- K060301: Palomar LUX1540 Handpiece, Palomar Medical Technologies, Inc. (2006) Summary page 1.
- K073583: Modification to Palomar LUX1540 Handpiece, Palomar Medical Products, Inc. (2008) Summary page 1.

## Most influential descendants
- K101916: Joule Multi-Platform System (2011), 111 descendants of its own
- K132806: Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece (2014), 70 descendants of its own
- K143723: SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro (2015), 62 descendants of its own
- K140009: Soprano Ice Multi-Application & Multi-Technology Platform (2014), 57 descendants of its own
- K110907: Palomar Icon (TM) Aesthetic System (2011), 57 descendants of its own

## Indications for use
The Lux1540 and Lux2940 fractional combined treatment is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, dyschromia and pigmented lesions. The Lux 1440 and Lux:2940 fractional combined treatment is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregulariiies, dyschromia and pigmented lesions.

Source page: https://510kreport.com/device/K101506
Methodology: https://510kreport.com/methodology