# K040921: Cooltouch, Model NS 160

- Pathway: 510(k) (Traditional)
- Applicant: Cooltouch, Inc.
- Decided: Sep 28, 2004 after 173 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: 8 generations back to K943450 (1995). 26 ancestors in all.
204 later devices descend from it; 2 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)
- K023543: Evlt Kit and D15PLUS and D30PLUS Diode, Diomed, Inc. (2002) Summary page 1.
- K012398: Diomed 15 Diode Laser, Diomed, Ltd. (2002) Summary page 1.
- K030700: Ceralas D 10-60 810NM Laser System with Endo Laser Vein System Kit, Biolitec, Inc. (2003) Summary page 1.
- K024088: Ceralas D 980 Laser System with Endo Laser Vein System Kit, Model: D15 and D25, Biolitec, Inc. (2003) Summary page 1.

## 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
- K082230: Vectra Plus Laser System and Accessories (2010), 112 descendants of its own
- K101916: Joule Multi-Platform System (2011), 111 descendants of its own

## Indications for use
The CoolTouch NS-160 Nd:YAG Laser System is indicated for the treatment of reflux of the greater saphenous vein associated with varicose veins and varicosities.

Source page: https://510kreport.com/device/K040921
Methodology: https://510kreport.com/methodology