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Carl Zeiss, Inc.

United StatesFDA applicant, unverified

Devices
45

What Carl Zeiss, Inc. makes

Carl Zeiss, Inc. manufactures ophthalmic surgical instruments, laser systems, and diagnostic imaging devices, including slit-lamps with micromanipulators, surgical microscopes, laser indirect ophthalmoscopes, and YAG/argon/diode-pumped solid-state lasers for retinal and corneal procedures. The portfolio also includes optical coherence tomography (OCT) scanners for retinal imaging and sterile disposable surgical drapes for procedural use.

The company’s devices are regulated under FDA classifications, including Class I (low-risk instruments), Class II (special controls), and Class III (premarket approval-requiring products). Devices are listed via 510(k) clearances and PMA submissions, with manufacturing operations based in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue45

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  • S 21 Instrument Stand Ref K883578

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Zeiss Multiyag Laser Ref K920529

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Zeiss 20 Sl Slit-Lamp & Mechanical Micromanipulatr Ref K925641

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • S 22 Instrument Stand Ref K891584

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Opmi Twiner Surgical Microscope Ref K983868

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Zeiss Laser Indirect Ophthalmoscope Ref K924588

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Zeiss Visulas Argon Laser Ref K923341

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Mkm (Multiple Coordinate Manipulator) System Ref K942233

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Nd:yag Surgical Laser Ref K920120

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Humphrey Oct Scanner Ref K961171

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Zeiss Disposable, Sterile Surgical Drape Ref K800552

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Zeiss Diode-Pumped Solid State Laser Ref K925642

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Zeiss Superlux High-Intensity Light Sources Ref K936198

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Mobile Operating Table For Orl Microsurgery Ref K853720

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Zeiss Voice Control System For Opmi's Ref K860811

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Zeiss Operating Keratometer Ref K853723

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Zeiss 30 Sl-L Ref K862004

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Oscar Color Vision Tester Ref K831074

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Zeiss Visulas Argon Laser Ref K874609

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Visulink 900 Argon Ref K952894

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Zeiss Multi Yag Laser Ref K920967

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Zeiss Multiyag Laser Ref K915840

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Zeiss 40 Sl/P Photo Slit Lamp Ref K874160

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cpc Probe Ref K961380

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Indirect Ophthalmoscope Ref K853891

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Zeiss Confocal Laser Scanning Ophthalmoscope(Clso) Ref K912581

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Humphrey Field Analyzer (Hfa Ii) Ref K954167

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Keratolux Ref K854383

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Opmi Md Surgical Microscope Ref K874241

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Zeiss Endolive Stero Endoscope Ref K950985

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ziess Endoprobe Ref K922735

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Zeiss Opmilas 144 Surgical Lasers Ref K933322

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Visulas Yag Ii Ref K003885

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Zeiss Visulas Diode Laser Ref K923274

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Zeiss Multiyag Laser Ref K915561

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Zeiss Visulas Yag Ii Laser Ref K926452

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Zeiss Opmilas 144 Surgical Lasers Ref K932376

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Surgical Microscope Navigator (Smn) System/Surgical Tool Navigator (Stn) System Ref K965139

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Visulas 532S Ref K013402

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Iolmaster Ref K993357

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Opmilas CO2-L Ref K894393

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • S 4 Instrument Stand Ref K884876

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Opmi Cs Ref K883581

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Zeiss Opmi L Stereo-Laparoscope Ref K931478

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Visulas Nd:yag Laser Ref P850083

    Active Regimes: PMA Registry: PMA Class:III

Rows 1-45 of 45

Frequently asked questions

How many devices does Carl Zeiss, Inc. have in the registry?

The registry currently lists 45 devices for Carl Zeiss, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Carl Zeiss, Inc.'s devices?

Among its 45 most recently registered devices, Carl Zeiss, Inc. has devices listed in FDA 510(k) (44 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Carl Zeiss, Inc.'s devices fall under?

Among its 45 most recently registered devices, the classes recorded for Carl Zeiss, Inc.'s devices are Class I, Class II and Class III. Each device page shows its own class and authorisation.

What are the newest devices from Carl Zeiss, Inc. in the registry?

The most recently registered devices listed for Carl Zeiss, Inc. include S 21 INSTRUMENT STAND, ZEISS MULTIYAG LASER, ZEISS 20 SL SLIT-LAMP & MECHANICAL MICROMANIPULATR and S 22 INSTRUMENT STAND.

Generated automatically from registry data and not verified by a human reviewer.