# K033549: Starlux Pulsed Light System

- Pathway: 510(k) (Traditional)
- Applicant: Palomar Medical Products, Inc.
- Decided: Mar 10, 2004 after 119 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
No predicates in its family tree.
679 later devices descend from it; 12 cite it directly.
0 of 680 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) EsteLux Pulsed Light System: named in the summary without a submission number
- (no number) Lumenis VascuLight (Family of IPL): named in the summary without a submission number

## Most influential descendants
- K041086: Palomar Starlux Pulsed Light System (2005), 365 descendants of its own
- K041969: Aurora DS (2004), 302 descendants of its own
- K050796: Aurora DS, DS Applicator (2005), 301 descendants of its own
- K053540: Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are Used with Them to Deliver Laser Ene (2006), 299 descendants of its own
- K072564: Alma Lasers Harmony XL Multi-Application Platform (2008), 266 descendants of its own

## Indications for use
The StarLuxTM Pulsed Light system is indicated for: · The removal of unwanted hair from skin types I-VI, and to effect stable long-term, or permanent, hair reduction. · The treatment of benign pigmented lesions, including lem:igines, nevi, melasma, and caf6-au-lait. · The treatment of vascular lesions, including port wine stains, hetnangiomas, angiomas, telangiectasias, rosacea, facial and leg veins.

Source page: https://510kreport.com/device/K033549
Methodology: https://510kreport.com/methodology