510(k) Report

FDA applicant

Carl Zeiss, Inc.

Thornwood, NY44 decisions1980–20015 recalls

FDA records 44 decisions for Carl Zeiss, Inc. (Thornwood, NY) from 1980 to 2001: 44 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and HJO (Biomicroscope, Slit-Lamp, Ac-Powered). Its devices cite 8 predicates, 3 of them its own earlier devices. 5 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Carl Zeiss, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Carl Zeiss, Inc. since 2007.

Recalls per year

2in 2015

2013: 22015: 2
2007high 2 (2013) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Carl Zeiss, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Carl Zeiss, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GEXPowered Laser Surgical Instrument17decisions
  • HJOBiomicroscope, Slit-Lamp, Ac-Powered4decisions
  • EPTMicroscope, Surgical3decisions
  • FSHTray, Surgical, Needle2decisions
  • HQFLaser, Ophthalmic2decisions
  • HLIOphthalmoscope, Ac-Powered2decisions

Also: HPL (1), HAW (1), GCJ (1), HRM (1), GCT (1), HET (1).

Whose devices does it build on?

Its devices cite 8 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 33 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K013402Visulas 532SCarl Zeiss, Inc. · 20015cite it
  • K965139Surgical Microscope Navigator (SMN) System/Surgical Tool Navigator (STN) SystemCarl Zeiss, Inc. · 19974cite it
  • K954167Humphrey Field Analyzer (Hfa II)Carl Zeiss, Inc. · 19954cite it
  • K950985Zeiss Endolive Stero EndoscopeCarl Zeiss, Inc. · 19953cite it
  • K993357IolmasterCarl Zeiss, Inc. · 20003cite it
  • K912581Zeiss Confocal Laser Scanning Ophthalmoscope (Clso)Carl Zeiss, Inc. · 19912cite it

What has FDA decided for it lately?

  • K013402Visulas 532SCarl Zeiss, Inc. · 20011 recall
  • K003885Visulas Yag IICarl Zeiss, Inc. · 2001
  • K993357IolmasterCarl Zeiss, Inc. · 20004 recalls
  • K983868Opmi Twiner Surgical MicroscopeCarl Zeiss, Inc. · 1999
  • K965139Surgical Microscope Navigator (SMN) System/Surgical Tool Navigator (STN) SystemCarl Zeiss, Inc. · 1997
  • K961380CPC ProbeCarl Zeiss, Inc. · 1997
  • K961171Humphrey Oct ScannerCarl Zeiss, Inc. · 1996
  • K954167Humphrey Field Analyzer (Hfa II)Carl Zeiss, Inc. · 1995

All 44 as Carl Zeiss, Inc. →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K101182IOL Master 5.5: Software versions 7.5 and 7.7; Ophthalmic: used to obtain ocular…Oct 27, 2015Class II
  • K101182IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended…Oct 27, 2015Class II
  • K101182Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is…Oct 23, 2013Class II
  • K101182Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, Product is…Oct 23, 2013Class II
  • K013402Surgical powered laser instrument, used for photocoagulation of ocular tissues in the…Jun 3, 2004

Other applicant names beginning “Carl”

FDA records each applicant name separately; these may or may not be the same firm.

Carl Zeiss Meditec, AG 81Carl Zeiss Meditec Cataract Technology, Inc. 7Carl Parker Associates, Inc. 7Carl Zeiss Surgical GmbH 4Carl Zeiss Ophthalmic Systems, Inc. 2Carl Zeiss Suzhou Co., Ltd. 2Carl Zeiss Jena GmbH 1Carl Zeiss Vision GmbH 1Carl Schuh 1Carl Zeiss Meditec Production, LLC 1Carl Zeiss Meditec Cataract Technologies 1