Sound Vaser System

• • Terminated Z-0939-2011 FDA Unclassified (pre-2012) ·initiated 21 Dec 2010 ·on shared 510(k) K991791

  Surgical equipment, activated by a wireless foot switch, may remain powered on when switch is no longer depressed.

• • Terminated Z-0933-2008 FDA Unclassified (pre-2012) ·initiated 28 Dec 2007 ·on shared 510(k) K991791

  Failure to shut-off: Surgical equipment, activated by a wireless foot switch with VASER system, may remain powered on when switch is no longer depressed.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K991791 ↗

FDA Product Code

LFL

Device Class

U

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

• Origins Lipoharvesting System

  Class II

  FDA 510(k) K120328 Active Cleared 17 Sep 2012

• Soundvaser System

  Class II

  FDA 510(k) K022051 Active Cleared 11 Sep 2002

• The Soundvaser Dissection System

  Unclassified

  FDA 510(k) K993868 Active Cleared 21 Dec 1999

• Sound Surgical Technologies LLC Powerx Lipo System

  Class II

  FDA 510(k) K110255 Active Cleared 4 Apr 2011

• Sound Surgical Vaser 2.1 Lipo System

  Class II

  FDA 510(k) K110306 Active Cleared 23 Jun 2011