# K041086: Palomar Starlux Pulsed Light System

- Pathway: 510(k) (Traditional)
- Applicant: Palomar Medical Products, Inc.
- Decided: Jan 13, 2005 after 262 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: 6 generations back to K910422 (1992). 53 ancestors in all.
365 later devices descend from it; 14 cite it directly.
0 of 419 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040081: Palomar Luxv Handpiece, Palomar Medical Technologies, Inc. (2004) Summary page 1.
- K033549: Starlux Pulsed Light System, Palomar Medical Products, Inc. (2004) Summary page 1.
- K003886: Palomar Spalight Pulsed Light System, Palomar Medical Technologies, Inc. (2001) Summary page 1.
- K020839: Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL, Lumenis, Inc. (2002) Summary page 1.

## Most influential descendants
- K072564: Alma Lasers Harmony XL Multi-Application Platform (2008), 266 descendants of its own
- K083899: Revlite Q-Switched ND:Yag Laser System (2009), 198 descendants of its own
- K083889: Fotona QX ND:Yag/KTP Laser System Family (2009), 166 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 StarLux pulsed light system is intended for the treatment of inflammatory acne (acne vulgaris) and for the treatment of benign pigmented epidermal and cutaneous lesions, including warts, scars and striae.

Source page: https://510kreport.com/device/K041086
Methodology: https://510kreport.com/methodology