Greenlight Hps Series Surgical Laser System & Accessories

• • Ongoing Z-1392-2022 FDA Class III ·initiated 31 May 2022

  Several complaints were received for the affected lot; users received a "Fiber type does not match card type" error message on the GreenLight XPS Laser console, necessitating the replacement of the laser fiber and fiber card. This may result in prolonged procedure while the fiber is being replaced.

• • Terminated Z-0700-2013 FDA Class II ·initiated 11 Dec 2012

  During electrical recertification testing it was found that the Voltage Scaling Board was non-conforming to the IEC 60601-1-2 standard.

• • Terminated Z-2502-2010 FDA Unclassified (pre-2012) ·initiated 22 Jan 2010

  Product may be packed with incorrect external or internal labels and/or missing product insert.

• • Terminated Z-0131-2008 FDA Unclassified (pre-2012) ·initiated 18 Jun 2007

  Control knob break: The knob used to finely control the direction of the laser energy may break.

• • Terminated Z-0130-2008 FDA Unclassified (pre-2012) ·initiated 17 Apr 2007

  Component missing: Some products were issued without thermal protection switches.

510(k) Number

K062719 ↗

FDA Product Code

GEX

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Ktp/532 & Ktp/Yag

  Class II

  FDA 510(k) K913990 Active Cleared 2 Sep 1992

• Ktp/Yag and Ktp/Yag Plus

  Class II

  FDA 510(k) K914518 Active Cleared 2 Apr 1992

• Ktp/532 and Ktp/Yag

  Class II

  FDA 510(k) K913758 Active Cleared 20 Nov 1991

• Ktp/532 Laser

  Class II

  FDA 510(k) K873330 Active Cleared 18 Nov 1987

• Ktp/532 Surgical Laser

  Class II

  FDA 510(k) K884029 Active Cleared 25 Nov 1988

• 800 Series Surgical Laser System and Acccessories

  Class II

  FDA 510(k) K970948 Active Cleared 21 May 1997

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