# K024259: Pulsed Light Therapy System, Model# UV-300

- Pathway: 510(k) (Traditional)
- Applicant: New Star Lasers, Inc.
- Decided: Jun 20, 2003 after 179 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). 64 ancestors in all.
No later device cites it as a predicate yet.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020839: Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL, Lumenis, Inc. (2002)
- K020591: Bclear, Lumenis (2002)
- K020856: Spatouch Photoepilation System, Radiancy (Israel), Ltd. (2002)
- K020453: Palomar Estelux Pulsed Light System and Palomar Coolroller, Palomar Medical Technologies, Inc. (2002)
- K013365: Prolite Pulsed Light System for the Treatment of Pigmented Lesions and the Removal of Tattoos, Medical Bio Care Sweden AB (2002)
- K022568: Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair, Medical Bio Care Sweden AB (2002)

## Indications for use
The New Star Lasers UV-300 Pulsed Light Therapy System is indicated for the treatment of facial, truncaI or leg telangiectasia and/or reticular veins, rosasia, port wine stains, hemangiomas, psoriasis, vitiligo, vascular lesions, atopic dermatitis (eczema), seborrheic dermatitis, hair removal, and tattoos. The UV-300 may be used to treat patients with skin types I-VI.

Source page: https://510kreport.com/device/K024259
Methodology: https://510kreport.com/methodology