# K073583: Modification to Palomar LUX1540 Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Palomar Medical Products, Inc.
- Decided: Mar 26, 2008 after 97 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: 11 generations back to K910422 (1992). 101 ancestors in all.
159 later devices descend from it; 3 cite it directly.
0 of 261 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071768: Erbium Fractional Handpiece, Palomar Medical Products, Inc. (2007) Summary page 1.
- K061652: Palomar LUX1540 Handpiece, Palomar Medical Products, Inc. (2007) Summary page 1.

## Most influential descendants
- K091446: Modification to LUX1540 Handpiece and Lux 1440 Handpiece (2009), 158 descendants of its own
- 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

## Indications for use
Dermatological procedures requiring the coagulation of soft tissue; Skin resurfacing procedures.

Source page: https://510kreport.com/device/K073583
Methodology: https://510kreport.com/methodology