NS3000 Holmium Laser System

• • Terminated Z-1918-2015 FDA Class II ·initiated 13 May 2015

  During internal testing a situation was discovered where when changing the settings, a new setting could not be accepted and potentially result in a discrepancy in the energy delivered (higher or lower) from the value displayed on the Graphical User Interface display.

510(k) Number

K142286 ↗

FDA Product Code

GEX

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

• Cool Touch 3

  Class II

  FDA 510(k) K031184 Active Cleared 21 May 2003

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