Indirect Ophthalmoscope

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K853891 ↗

FDA Product Code

HLJ

Device Class

Class II

Regulation

21 CFR Part 886.1570

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

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  Class I

  FDA 510(k) K883578 Active Cleared 13 Sep 1988

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  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

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  FDA 510(k) K891584 Active Cleared 8 Jun 1989

• Opmi Twiner Surgical Microscope

  Class II

  FDA 510(k) K983868 Active Cleared 29 Jan 1999

• Zeiss Laser Indirect Ophthalmoscope

  Class II

  FDA 510(k) K924588 Active Cleared 9 Jul 1993

See all devices from Carl Zeiss, Inc. →