800 Series Surgical Laser System Orion Series Surgical Laser System Angled Delivery Devices

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K972575 ↗

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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