Cooltouch; Cooltouch II; and Cooltouch CT3 Nd:yag Laser System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K040131 ↗

FDA Product Code

GEX

Models / Variants

Cooltouch

Cooltouch Ii

And Cooltouch CT3 Nd:yag Laser System

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Cooltouch, Model CT3S

  Class II

  FDA 510(k) K043046 Active Cleared 1 Feb 2005

• Cooltouch Thermal Sensing Handpiece Accessory

  Class II

  FDA 510(k) K090410 Active Cleared 27 Mar 2009

• Cooltouch Incorporated MODELCT3 Nd:yag Surgical Laser Systems

  Class II

  FDA 510(k) K031954 Active Cleared 21 Aug 2003

• Cooltouch Models LC215 and Coollipo

  Class II

  FDA 510(k) K080163 Active Cleared 10 Apr 2008

• Cooltouch Models Ns 160 and LC215 Coolipo

  Class II

  FDA 510(k) K072751 Active Cleared 2 Jan 2008

• NS3000 Holmium Laser System

  Class II

  FDA 510(k) K142286 Active Cleared 31 Oct 2014

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