Fraxel Re:store Dual Laser System: Model, Mc-Sys-SR1500-D-Us

• • Terminated Z-1463-2014 FDA Class II ·initiated 20 Mar 2014

  Obsolete versions of the Laser Treatment Settings card for the Fraxel DUAL 1550/1927 Laser system may have contained incorrect indication for use for treatment of Melasma.

• • Terminated Z-1010-2011 FDA Unclassified (pre-2012) ·initiated 15 Dec 2010

  The product has the potential to cause inadvertent laser firing which may lead to patient/operator injury if the problem recurs.

510(k) Number

K101490 ↗

FDA Product Code

ONG

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Thermassage

  Class II

  FDA 510(k) K061001 Active Cleared 12 Oct 2006

• Modification to: Thermacool Iia

  Class II

  FDA 510(k) K013034 Active Cleared 4 Oct 2001

• Thermage Thermacool System

  Class II

  FDA 510(k) K040135 Active Cleared 21 Jun 2004

• Modification to Thermacool Tc System

  Class II

  FDA 510(k) K032088 Active Cleared 1 Aug 2003

• Modification to Thermage Thermacool System

  Class II

  FDA 510(k) K053365 Active Cleared 13 Dec 2005

• Thermage Thermacool Tc System

  Class II

  FDA 510(k) K013639 Active Cleared 29 Jan 2002

See all devices from Thermage, Inc. →