Opmi Twiner Surgical Microscope

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K983868 ↗

FDA Product Code

GEX

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• S 21 Instrument Stand

  Class I

  FDA 510(k) K883578 Active Cleared 13 Sep 1988

• Zeiss Multiyag Laser

  Class II

  FDA 510(k) K920529 Active Cleared 2 Apr 1992

• Zeiss 20 Sl Slit-Lamp & Mechanical Micromanipulatr

  Class II

  FDA 510(k) K925641 Active Cleared 9 Sep 1993

• S 22 Instrument Stand

  Class I

  FDA 510(k) K891584 Active Cleared 8 Jun 1989

• Zeiss Laser Indirect Ophthalmoscope

  Class II

  FDA 510(k) K924588 Active Cleared 9 Jul 1993

• Zeiss Visulas Argon Laser

  Class II

  FDA 510(k) K923341 Active Cleared 28 Oct 1992

See all devices from Carl Zeiss, Inc. →