# K051434: Cooltouch ND:Yag Laser Systems, Models CT3S and Ctev

- Pathway: 510(k) (Traditional)
- Applicant: New Star Lasers, Inc.
- Decided: Aug 9, 2005 after 69 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.
230 later devices descend from it; 3 cite it directly.
0 of 231 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 NS-160 (CTEV) and CT3S Nd:YAG Laser Systems: named in the summary without a submission number

## Most influential descendants
- K060033: Profile Multi-Platform System (2006), 221 descendants of its own
- 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

## Indications for use
In addition to previously cleared indications for use, the CoolTouch CTEV and CT3S Nd:YAG Laser Systems are indicated for the treatment of reflux of the small saphenous vein associated with varicose veins and varicosities.

Source page: https://510kreport.com/device/K051434
Methodology: https://510kreport.com/methodology