# K061618: Cooltouch, Model Ctev

- Pathway: 510(k) (Traditional)
- Applicant: New Star Lasers, Inc.
- Decided: Sep 25, 2006 after 108 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.
234 later devices descend from it; 4 cite it directly.
0 of 235 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 Inc. Model CTEV (NS-160) Nd:YAG Laser Systems: named in the summary without a submission number

## Most influential descendants
- K073063: 15W Ceralas D 1470NM Diode Laser (2008), 202 descendants of its own
- K083613: Quanta System Polysurge Diode Laser Family (2008), 192 descendants of its own
- K090164: Ceralas Multiwavelength 980/1470NM Diode Laser (2009), 177 descendants of its own
- K070388: Profile Multi-Platform System (2007), 129 descendants of its own
- K082225: 15W Ceralas D 1470NM Diode Laser, Model D1470 (2008), 128 descendants of its own

## Indications for use
The CoolTouch CTEV Nd:YAG Laser System is indicated for the treatment of superficial incompetent tributary veins associated with varicose veins and varicosities.

Source page: https://510kreport.com/device/K061618
Methodology: https://510kreport.com/methodology