# K031954: Cooltouch Incorporated MODELCT3 ND:Yag Surgical Laser Systems

- Pathway: 510(k) (Traditional)
- Applicant: New Star Lasers, Inc.
- Decided: Aug 21, 2003 after 57 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.
518 later devices descend from it; 1 cites it directly.
0 of 519 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) CoolTouch Incorporated “CoolTouch” Nd:YAG Laser System: named in the summary without a submission number
- (no number) CoolTouch Incorporated “CoolTouch II” Nd:YAG Laser System: named in the summary without a submission number

## 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 CT3 Laser System is indicated for: 1. treatment of back acne 2. treatment of atrophic acne scars.

Source page: https://510kreport.com/device/K031954
Methodology: https://510kreport.com/methodology