# K014035: Cooltouch and Cooltouch-II ND:Yag Laser Systems

- Pathway: 510(k) (Traditional)
- Applicant: Cooltouch Corp.
- Decided: Mar 7, 2002 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: 2 generations back to K820106 (1982). 6 ancestors in all.
668 later devices descend from it; 4 cite it directly.
0 of 675 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962791: New Star Model 130 6-Watt ND: Yag Laser System, New Star Lasers, Inc. (1997) Summary page 1.

## Most influential descendants
- K022226: Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future Models (2002), 665 descendants of its own
- K022466: Profile 1320 Laser System (2002), 520 descendants of its own
- K033251: The Friendlylight ND: Yag Lasers (2004), 519 descendants of its own
- 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

## Indications for use
The CoolTouch Nd:YAG Laser Systems are indicated fer the treatment of periorbital and perioral wrinkles.

Source page: https://510kreport.com/device/K014035
Methodology: https://510kreport.com/methodology