# K043046: Cooltouch, Model CT3S

- Pathway: 510(k) (Traditional)
- Applicant: New Star Lasers, Inc.
- Decided: Feb 1, 2005 after 89 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.
321 later devices descend from it; 4 cite it directly.
0 of 322 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 Corporation Model NS-160, CTEV: named in the summary without a submission number

## Most influential descendants
- K060033: Profile Multi-Platform System (2006), 221 descendants of its own
- K053047: Fraxel SR Laser System (2006), 205 descendants of its own
- K073063: 15W Ceralas D 1470NM Diode Laser (2008), 202 descendants of its own
- K063038: Fraxel Iii SR Laser System and Accessories (2007), 195 descendants of its own
- K071051: Fraxel Iii SR Laser System and Accessories (2007), 194 descendants of its own

## Indications for use
The CoolTouch CT3S Nd:YAG Laser System is indicated: a) for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue, b) for use in the treatment of fine lines and wrinkles, c) for treatment of back acne and atrophic acne scars, d) for treatment of reflux of the greater saphenous vein associated with varicose veins and varicosities.

Source page: https://510kreport.com/device/K043046
Methodology: https://510kreport.com/methodology