# K020453: Palomar Estelux Pulsed Light System and Palomar Coolroller

- Pathway: 510(k) (Traditional)
- Applicant: Palomar Medical Technologies, Inc.
- Decided: May 10, 2002 after 88 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: 5 generations back to K910422 (1992). 18 ancestors in all.
1,018 later devices descend from it; 15 cite it directly.
0 of 1,037 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991935: Epilight Hair Removal System, Photoderm HR System, Esc Medical Systems, Ltd. (2000) Summary page 1.
- K984110: Laserscope Coolspot, Laserscope (1998) Summary page 1.

## Most influential descendants
- K033946: Lovely System (2004), 737 descendants of its own
- K032460: Profile BBL System (2003), 569 descendants of its own
- K030426: Omnilux Red (2003), 563 descendants of its own
- K042000: Modified MSQ Family of Lovely Light/Laser Systems (2004), 517 descendants of its own
- K042630: Revlight Skin Care System (2005), 402 descendants of its own

## Indications for use
The EsteLux™ Pulsed Light system is intended to for permanent bair reduction. It is also indicated for photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels (treatment of facial and leg veins), and the treatment of benign pigmented lesions. The CoolRoller™ is intended to provide pre-cooling of the epidermis, to reduce thermal injury to the epidermis, and to reduce pain and patient discomfort associated with light applications.

Source page: https://510kreport.com/device/K020453
Methodology: https://510kreport.com/methodology