# K080244: Palomar Lux 1540 Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Palomar Medical Products, Inc.
- Decided: Jun 20, 2008 after 141 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: 12 generations back to K910422 (1992). 132 ancestors in all.
161 later devices descend from it; 4 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)
- K060301: Palomar LUX1540 Handpiece, Palomar Medical Technologies, Inc. (2006) Summary page 1.
- K061652: Palomar LUX1540 Handpiece, Palomar Medical Products, Inc. (2007) Summary page 1.
- K070284: Fralex SR 1500 Laser System (Fralex II SR Laser System), Reliant Technologies, Inc. (2007) Summary page 1.
- K062303: Fraxel II SR Laser System, Reliant Technologies, Inc. (2007) Summary page 1.
- K042319: Reliant Laser II System and Accessories, Reliant Technologies, Inc. (2005) Summary page 1.

## Most influential descendants
- K090195: Palomar LUX1540 Handpiece (2009), 158 descendants of its own
- K091446: Modification to LUX1540 Handpiece and Lux 1440 Handpiece (2009), 158 descendants of its own
- K083900: Erbium Fractional 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

## Indications for use
The Palomar LuxI540 handpiece is intended for use in dermatological procedures requiring: Coagulation of soft tissue, skin resurfacing procedures, melasma, acne scars, and surgical scars.

Source page: https://510kreport.com/device/K080244
Methodology: https://510kreport.com/methodology