# K040131: Cooltouch; Cooltouch II; and Cooltouch CT3 ND:Yag Laser System

- Pathway: 510(k) (Traditional)
- Applicant: New Star Lasers, Inc.
- Decided: Apr 20, 2004 after 90 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: 4 generations back to K002421 (2000). 5 ancestors in all.
569 later devices descend from it; 5 cite it directly.
0 of 575 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030834: Candela Smoothbeam Laser System, Candela Corp. (2003) Summary page 1.

## Most influential descendants
- K042000: Modified MSQ Family of Lovely Light/Laser Systems (2004), 517 descendants of its own
- K072564: Alma Lasers Harmony XL Multi-Application Platform (2008), 266 descendants of its own
- K060033: Profile Multi-Platform System (2006), 221 descendants of its own
- K073063: 15W Ceralas D 1470NM Diode Laser (2008), 202 descendants of its own
- K083899: Revlite Q-Switched ND:Yag Laser System (2009), 198 descendants of its own

## Indications for use
The CoolTouch®, CoolTouch® II, and CoolTouch® CT3 ND:YAG Laser Systems are indicated for the treatment of mild to moderate inflammatory acne vulgaris.

Source page: https://510kreport.com/device/K040131
Methodology: https://510kreport.com/methodology