# K061652: Palomar LUX1540 Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Palomar Medical Products, Inc.
- Decided: Feb 27, 2007 after 259 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: 10 generations back to K910422 (1992). 99 ancestors in all.
259 later devices descend from it; 3 cite it directly.
0 of 359 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042319: Reliant Laser II System and Accessories, Reliant Technologies, Inc. (2005) Summary page 1.
- K060301: Palomar LUX1540 Handpiece, Palomar Medical Technologies, Inc. (2006) Summary page 1.

## Most influential descendants
- K080244: Palomar Lux 1540 Handpiece (2008), 161 descendants of its own
- K073583: Modification to Palomar LUX1540 Handpiece (2008), 159 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K061652
Methodology: https://510kreport.com/methodology