Laserpro 810, 940 and 980 Diode Laser Systems

• • Terminated Z-0005-2014 FDA Class II ·initiated 4 Jan 2013

  Firm became aware that some products within the specified lot may not have been sealed appropriately, thus compromising the sterile barrier.

510(k) Number

K082721 ↗

FDA Product Code

GEX

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Laserpro Diode Laser Systems, Models 810, 940 & 980

  Class II

  FDA 510(k) K040294 Active Cleared 5 May 2004

• Xtrac Ultra 2, Model AL10000

  Class II

  FDA 510(k) K073659 Active Cleared 5 Mar 2008

• Xtracxl Plus Excimer Laser System, Model AL7000

  Class II

  FDA 510(k) K031451 Active Cleared 1 Aug 2003

• XTRAC Excimer Laser System, Model AL 7000

  Class II

  FDA 510(k) K011382 Active Cleared 2 Aug 2001

• Xtrac Excimer Laser System, Model AL7000

  Class II

  FDA 510(k) K003705 Active Cleared 1 Mar 2001

• Laserpro CO2 Carbon Dioxide Laser System

  Class II

  FDA 510(k) K040234 Active Cleared 2 Apr 2004

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