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Data / Medical devices / Germany / Carl Zeiss Meditec AG (jena)

Carl Zeiss Meditec AG (jena): FDA-registered device maker in JENA Thuringia, Germany, 40 510(k) clearances and 2 PMA approvals

Carl Zeiss Meditec AG (jena) is registered with the FDA (registration 3038356864) in JENA Thuringia, Germany. It lists 23 device types. The FDA files 40 510(k) clearances and 2 PMA approvals under its listings, the newest dated July 17, 2026. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Carl Zeiss Meditec AG (jena)
FDA registration number
3038356864
Address
Goeschwitzer Strasse 51-52, JENA Thuringia, Germany, 07745
Owner or operator
Carl Zeiss Meditec AG (Jena) (9053564)
Roles
Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler, Specification developer
First device listed
October 2, 1992
Registered through
2026
Brand names listed
AT 030, ATLAS 500, CALLISTO eye, CIRRUS Photo Models 600 and 800, CIRRUS photo Models 600 and 800, CLINIC 360, EyeMag Light II, FF450 Plus VISUPAC System and more

Devices it lists

DeviceProduct codeClassRoleSource
Biomicroscope, Slit-Lamp, Ac-PoweredHJO2Specification developeraccessdata.fda.gov
Camera, Ophthalmic, Ac-PoweredHKI2Foreign private label distributor, Specification developeraccessdata.fda.gov
Chart, Visual AcuityHOX1Foreign private label distributoraccessdata.fda.gov
Device, Communications, Images, OphthalmicNFG1Specification developeraccessdata.fda.gov
Device, Storage, Images, OphthalmicNFF1Specification developeraccessdata.fda.gov
Excimer Laser SystemLZS3Specification developeraccessdata.fda.gov
Femtosecond Laser System For Refractive CorrectionOTL3Specification developeraccessdata.fda.gov
Instrument, Measuring, Lens, Ac-PoweredHLM1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Keratome, Ac-PoweredHNO1Specification developeraccessdata.fda.gov
Laser, OphthalmicHQF2Specification developeraccessdata.fda.gov
Light, Examination, Medical, Battery PoweredKYT1Specification developeraccessdata.fda.gov
Marker, OcularHMR1Specification developeraccessdata.fda.gov
Microscope, Operating & Accessories, Ac-Powered, OphthalmicHRM1Specification developeraccessdata.fda.gov
Microscope, SurgicalEPT1Specification developeraccessdata.fda.gov
Ophthalmoscope, Battery-PoweredHLJ2Specification developeraccessdata.fda.gov
Powered Laser Surgical InstrumentGEX2Specification developeraccessdata.fda.gov
Refractometer, OphthalmicHKO1Repackager or relabeler, Specification developeraccessdata.fda.gov
Refractor, Manual, Non-Powered, Including PhoropterHKN1Repackager or relabeleraccessdata.fda.gov
System, Image Management, OphthalmicNFJ2Manufacturer, Specification developeraccessdata.fda.gov
Tomography, Optical CoherenceOBO2Specification developeraccessdata.fda.gov
Tonometer, Ac-PoweredHKX2Foreign private label distributor, Repackager or relabeleraccessdata.fda.gov
Tonometer, ManualHKY2Specification developeraccessdata.fda.gov
Topographer, Corneal, Ac-PoweredMMQ1Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
July 17, 2026K260694ZEISS CLINIC 360NFJSubstantially EquivalentCarl Zeiss Meditec, AGaccessdata.fda.gov
September 6, 2024K233911VISULAS combiHQFSubstantially EquivalentCarl Zeiss Meditec, AGaccessdata.fda.gov
December 21, 2023K232944CALLISTO eyeNFJSubstantially EquivalentCarl Zeiss Meditec, AGaccessdata.fda.gov
October 24, 2023K232051VISULAS greenHQFSubstantially EquivalentCarl Zeiss Meditecaccessdata.fda.gov
September 22, 2023K230350VISULAS yagHQFSubstantially EquivalentCarl Zeiss Meditec, Inc.accessdata.fda.gov
August 28, 2023K231676CALLISTO eyeNFJSubstantially EquivalentCarl Zeiss Meditec, AGaccessdata.fda.gov
March 6, 2019K181682VISULAS greenHQFSubstantially EquivalentCarl Zeiss Meditec, AGaccessdata.fda.gov
August 24, 2018K173771IOLMaster 700HJOSubstantially EquivalentCarl Zeiss Meditec, AGaccessdata.fda.gov
June 7, 2018K180839AT 030HKYSubstantially EquivalentCarl Zeiss Meditec, AGaccessdata.fda.gov
May 31, 2017K162684SL 220HJOSubstantially EquivalentCarl Zeiss Meditec, AGaccessdata.fda.gov
July 10, 2015K143275IOLMaster700HJOSubstantially EquivalentCarl Zeiss Meditec, Inc.accessdata.fda.gov
May 21, 2015K150467Retina WorkplaceNFJSubstantially EquivalentCarl Zeiss Meditec, AGaccessdata.fda.gov
October 3, 2014K141297FORUM GLAUCOMA WORKPLACENFJSubstantially EquivalentCarl Zeiss Meditec, AGaccessdata.fda.gov
September 9, 2014K141068ZEISS CATARACT SUITE MARKERLESSHJOSubstantially EquivalentCarl Zeiss Meditec, AGaccessdata.fda.gov
March 19, 2014K133217CIRRUS PHOTOOBOSubstantially EquivalentCarl Zeiss Meditec, AGaccessdata.fda.gov
February 12, 2014K133476SLIT LAMPS WITH SL CAM 5.0 DIGITAL IMAGING SOLUTIONHJOSubstantially EquivalentCarl Zeiss Meditec, AGaccessdata.fda.gov
July 23, 2013K130648FORUM GLAUCOMA WORKPLACENFJSubstantially EquivalentCarl Zeiss Meditec, AGaccessdata.fda.gov
April 12, 2013K122418IOLMASTER 500HJOSubstantially EquivalentCarl Zeiss Meditec, AGaccessdata.fda.gov
November 2, 2012K122938FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATCHNFJSubstantially EquivalentCarl Zeiss Meditec, AGaccessdata.fda.gov
June 18, 2012K112184CIRRUS PHOTOOBOSubstantially EquivalentCarl Zeiss Meditec, Inc.accessdata.fda.gov
February 1, 2011K103056VISULAS TRION LASER SYSTEM WITH THE VITE OPTIONHQFSubstantially EquivalentCarl Zeiss Meditec, AGaccessdata.fda.gov
November 3, 2010K101182IOLMASTER 500HJOSubstantially EquivalentCarl Zeiss Meditec, AGaccessdata.fda.gov
July 8, 2010K100253VISUMAX LASER KERATOMEHQFSubstantially EquivalentCarl Zeiss Meditec, AGaccessdata.fda.gov
March 17, 2010K100035MODEL VISULAS 532S LASER WITH THE VITE OPTIONGEXSubstantially EquivalentCarl Zeiss Meditec, AGaccessdata.fda.gov
March 25, 2009K090439FORUMNFJSubstantially EquivalentCarl Zeiss Meditec, Inc.accessdata.fda.gov
September 21, 2007K072514VISULAS TRIONGEXSubstantially EquivalentCarl Zeiss Meditec, AGaccessdata.fda.gov
December 22, 2006K062314HORUS LASER KERATOMEGEXSubstantially EquivalentCarl Zeiss Meditec, AGaccessdata.fda.gov
November 2, 2005K052268VISUCAM PRO NMHKISubstantially EquivalentCarl Zeiss Meditec, AGaccessdata.fda.gov
February 14, 2005K043222VISCUCAM C DIGITAL CAMERAHKISubstantially EquivalentCarl Zeiss Meditec, AGaccessdata.fda.gov
September 9, 2004K042139VISULAS YAG IIIGEXSubstantially EquivalentCarl Zeiss Meditec, AGaccessdata.fda.gov
January 20, 2004K032799NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZERHKXSubstantially EquivalentReichert, Inc.accessdata.fda.gov
November 14, 2001K013402VISULAS 532SGEXSubstantially EquivalentCarl Zeiss, Inc.accessdata.fda.gov
September 26, 2001K011877FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEMHKISubstantially EquivalentCarl Zeiss Jena GmbHaccessdata.fda.gov
February 22, 2001K003885VISULAS YAG IIGEXSubstantially EquivalentCarl Zeiss, Inc.accessdata.fda.gov
March 20, 2000K993357IOLMASTERHJOSubstantially EquivalentCarl Zeiss, Inc.accessdata.fda.gov
November 22, 1993K926452ZEISS VISULAS YAG II LASERGEXSubstantially EquivalentCarl Zeiss, Inc.accessdata.fda.gov
September 9, 1993K925641ZEISS 20 SL SLIT-LAMP & MECHANICAL MICROMANIPULATRHJOSubstantially EquivalentCarl Zeiss, Inc.accessdata.fda.gov
October 28, 1992K923341ZEISS VISULAS ARGON LASERGEXSubstantially EquivalentCarl Zeiss, Inc.accessdata.fda.gov
June 17, 1986K862004ZEISS 30 SL-LHJOSubstantially EquivalentCarl Zeiss, Inc.accessdata.fda.gov
October 4, 1985K853891INDIRECT OPHTHALMOSCOPEHLJSubstantially EquivalentCarl Zeiss, Inc.accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
September 13, 2016P150040VISUMAX FEMTOSECOND LASEROTL23May 26, 2026accessdata.fda.gov
August 11, 2006P060004MEL 80 EXCIMER LASER SYSTEMLZS9July 1, 2026accessdata.fda.gov

Compare with other makers

Updated July 17, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.