Alm Prismalix (Prx) Surgical Light

• • Ongoing Z-0767-2024 FDA Class II ·initiated 8 Nov 2023

  A potential for a light system to fall in the operating room.

510(k) Number

K982063 ↗

FDA Product Code

FSY

Device Class

Class II

Regulation

21 CFR Part 878.4580

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Drager Dve 8080/81/82 with Dve 4002 or Dve 4001 Series System

  Class I

  FDA 510(k) K961742 Active Cleared 26 Jul 1996

• Drager Gemina Wall-Mounted Workplace

  Class I

  FDA 510(k) K961886 Active Cleared 30 Jul 1996

• Bfw Wehmerlite IV-a Fiber Optic Surg. Headlight

  Class II

  FDA 510(k) K921848 Active Cleared 1 Oct 1992

• Drager Dve 4000 Series System

  Class I

  FDA 510(k) K921297 Active Cleared 27 Nov 1992

• Mta:angenieux Starpoint Xe Xenon Light Source

  Class II

  FDA 510(k) K945102 Active Cleared 4 Nov 1994

• Alm Operating Tables

  Class I

  FDA 510(k) K884019 Active Cleared 13 Oct 1988

See all devices from Alm Surgical Equipment, Inc. →