# K031184: Cool Touch 3

- Pathway: 510(k) (Special)
- Applicant: New Star Lasers, Inc.
- Decided: May 21, 2003 after 36 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.
519 later devices descend from it; 2 cite it directly.
0 of 520 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) New Star Lasers, Inc. Model NS-130 (CoolTouch) Nd:YAG Laser System: named in the summary without a submission number
- (no number) New Star Lasers, Inc. Model CoolTouch II Nd:YAG Laser System: named in the summary without a submission number

## Most influential descendants
- K032459: Profile 1320 Laser System (2004), 518 descendants of its own
- 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

## Indications for use
For use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue. For use in the treatment of fine lines and wrinkles.

Source page: https://510kreport.com/device/K031184
Methodology: https://510kreport.com/methodology