# K091446: Modification to LUX1540 Handpiece and Lux 1440 Handpiece

- Pathway: 510(k) (Special)
- Applicant: Palomar Medical Products, Inc.
- Decided: Oct 27, 2009 after 165 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: 13 generations back to K910422 (1992). 135 ancestors in all.
158 later devices descend from it; 2 cite it directly.
0 of 294 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080244: Palomar Lux 1540 Handpiece, Palomar Medical Products, Inc. (2008) Summary page 1.
- K073583: Modification to Palomar LUX1540 Handpiece, Palomar Medical Products, Inc. (2008) Summary page 1.
- K070284: Fralex SR 1500 Laser System (Fralex II SR Laser System), Reliant Technologies, Inc. (2007) Summary page 1.

## Most influential descendants
- K100270: Artisan Aesthetic System (2010), 157 descendants of its own
- K101506: LUX1540, LUX1440 & LUX2940 Laser Handpieces (2010), 156 descendants of its own
- 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

## Indications for use
The Palomar LuxI 540 handpiece is intended for use in dermatological procedures requiring: coagulation of soft tissue, skin resurfacing procedures, melasma, acne scars, and surgical scars. The Palomar Lux1440 handpiece is intended for use in dermatological procedures requiring: coagulation of soft tissue and skin resurfacing procedures.

Source page: https://510kreport.com/device/K091446
Methodology: https://510kreport.com/methodology