Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615010

FEI Number

3003481798

Entity Name

CARL ZEISS MEDITEC AG (OBERKOCHEN)

City/State/Country

OBERKOCHEN Baden-Wurttemberg, DE

Establishment Address

RUDOLF-EBER-STRASSE 11, OBERKOCHEN Baden-Wurttemberg D-73447, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Carl Zeiss Meditec AG (Jena) (Owner Number: 9053564)

Owner / Operator Contact Address

Goeschwitzer Strasse 51-52, Jena, DE-TH 07745, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

QEVO System QUATERA 700 INTRABEAM EyeMag Pro F (with accessories) EyeMag Smart (with accessories) EyeMag Classic EyeMag SMART TTL EyeMag Pro S (with accessories) INTRABEAM Balloon Applicator and CBG Sets CALLISTO eye CALLISTO EYE CALLISTO eye VISALIS 500 S88 / OPMI Lumera T S8/OPMI VISU 200 S100 / OPMI pico i RESIGHT 500 (with acccessories) RESIGHT 700 (with accessories) S8 / OPMI Lumera T S7 / OPMI VISU 160 S81 / OPMI Lumera T S7 / OPMI Lumera S7 / OPMI VISU 140 OPMI Lumera 700 OPMI 1 FR pro ARTEVO 800 UC 3D Digital Upgrade Kit S8/OPMI VISU 160 S8/OPMI VISU 210 OPMI Lumera i S81/OPMI VISU 160 S88/OPMI VISU 160 S88/OPMI VISU 210 S81/OPMI VISU 210 ARTEVO 750/850 Single-use lenses for RESIGHT OPMI Lumera 300 1 Chip HD Camera MediLive Trio Eye Sony HD Recorder HVO-500MD ZEISS Connect App MediLive 1 CCD TRIO 620 with CCU TRIO 600 MediLive TRIO 610 with CCU TRIO 600 MediLive Primo MediLive Trio dent TRIO 630 with CCU TRIO 600 MediLive Trio RESCAN 700, CALLISTO eye INTRABEAM System with Spherical Applicator Asepsis VISULUX Metal Sleeves INTRABEAM System with Needle Applicator VisionGuard Lens Protectors OPMI Drape DRAPES Sterile OPMI Drape Sterile Foot Switch Drapes Drapes SMARTDRAPE VisionGuard Replacement Lenses INTRABEAM Drape Asepsis Caps INTRABEAM SMARTDRAPE SMARTDRAPE Replacement Lenses INTRABEAM 600 BLUE 400 QUATERA 700 and Accessories CONVIVO In ViVo Pathology Suite INTRABEAM System with Flat Applicator INTRABEAM System with Surface Applicator NC 32 INTRABEAM Floor Stand INTRABEAM Cart FORUM Archive and Viewer FORUM Archive CALLISTO eye Panel PC YELLOW 560 Fluorescence Module Kolposkop E KSK 150 FC

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GWG	Endoscope, Neurological	Neurology	Class 2	882.1480	2023-10-23
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2022-04-19
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Ophthalmic	Class 2	886.4150	2022-04-19
JAD	System, Therapeutic, X-Ray	Radiology	Class 2	892.5900	2007-12-04
HOH	Spectacle, Operating (Loupe), Ophthalmic	Ophthalmic	Class 1	886.4770	2022-08-15
JAD	System, Therapeutic, X-Ray	Radiology	Class 2	892.5900	2010-07-14
NFJ	System, Image Management, Ophthalmic	Radiology	Class 2	892.2050	2013-03-15
EPT	Microscope, Surgical	General, Plastic Surgery	Class 1	878.4700	2013-03-15
HMR	Marker, Ocular	Ophthalmic	Class 1	886.4570	2013-03-15
HMR	Marker, Ocular	Ophthalmic	Class 1	886.4570	2009-09-02
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2022-02-04
HRM	Microscope, Operating & Accessories, Ac-Powered, Ophthalmic	General, Plastic Surgery	Class 1	878.4700	2011-12-08
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2003-02-11
OBO	Tomography, Optical Coherence	Ophthalmic	Class 2	886.1570	2014-11-19
JAD	System, Therapeutic, X-Ray	Radiology	Class 2	892.5900	2013-09-17
HMW	Drape, Microscope, Ophthalmic	General, Plastic Surgery	Class 2	878.4370	2017-04-20
JAD	System, Therapeutic, X-Ray	Radiology	Class 2	892.5900	2013-09-17
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2017-10-10
JAD	System, Therapeutic, X-Ray	Radiology	Class 2	892.5900	2017-01-31
QFX	Diagnostic Neurosurgical Microscope Filter	Neurology	Class 2	882.4950	2022-08-15
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2024-01-04
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Ophthalmic	Class 2	886.4150	2024-01-04
OWN	Confocal Optical Imaging	Gastroenterology, Urology	Class 2	876.1500	2022-01-11
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2022-01-11
GWG	Endoscope, Neurological	Neurology	Class 2	882.1480	2022-01-11
JAD	System, Therapeutic, X-Ray	Radiology	Class 2	892.5900	2013-09-17
KMN	Chair And Table, Medical	General Hospital	Class 1	880.6140	2014-08-06
NFJ	System, Image Management, Ophthalmic	Radiology	Class 2	892.2050	2013-03-18
LMD	System, Digital Image Communications, Radiological	Radiology	Class 1	892.2020	2003-12-29
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2017-10-10
PTZ	Colposcope (And Colpomicroscope), Exempt	Obstetrics/Gynecology	Class 2	884.1630	2017-11-09

Official Correspondent

Carl ZEISS Meditec AG (Jena)

US Agent Details

Paul Swift Business: CARL ZEISS MEDITEC USA, INC. Email: fdaagent.med.us@zeiss.com Phone: (817) 9258507

Related Public Records

Same Entity

Carl Zeiss Meditec AG (Jena)

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3015534077	Carl Zeiss Meditec Digital Innovations Inc	Temple, TX, US
3032734659	Carl Zeiss Meditec (Suzhou) Co., Ltd.	Suzhou Jiangsu, CN
3010126268	Carl Zeiss Meditec Production, LLC.	Ontario, CA, US
2918630	CARL ZEISS MEDITEC INC	DUBLIN, CA, US
3004467263	FCI SUD	MAPOU LECLEZIO GOODLANDS Riviere du Rempart, MU

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K091915	Lenstec, Inc.	FLUID ISOLATION DEVICE	2009-10-27
K830812	Alphamedix, Inc.	ALPHAMEDIX I/A HAND-PIECE, 500-001	1983-06-08
K133115	Abbott Medical Optics, Inc.	COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK	2014-02-27
K121721	Abbott Medical Optics, Inc.	LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE)	2012-10-15
K111697	Abbott Medical Optics, Inc.	AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM	2011-09-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2018	Carl Zeiss Meditec AG Rudolf-Eber-Str. 11 Oberkochen Germany	2	Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss Meditec AG, Jena, Germany. The INTRABEAM System is indicated for radiation therapy treatments
Z-1670-2013	Abbott Medical Optics, Inc.	2	Sovereign Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery.
Z-0099-2024	Alcon Research, LLC	2	Constellation Vision System, REF: 8065751150
Z-0305-2026	Alcon Research LLC	2	Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065750918 PAK,I/A LINE,NGVS 8065750957 ASSY,SHIP,CONSTELLATION VFC 8065750972 ENDOILLUMATOR,RFID,23G 8065751014 CONST AUTO GAS FILL PAK 8065751014 CONST AUTO GAS FILL PAK 8065751441 ENDOILLUMINATOR,RFID,25G 8065751577 CHANDELIER,25GA,W/RFID Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A
Z-1794-2020	Alcon Research LLC	2	Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.

Similar Registrations

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2011171	Sterigenics US LLC	Los Angeles, CA, US
2020550	KARL STORZ ENDOSCOPY-AMERICA, INC.	Auburn, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615010. Last updated year: 2026. Please use registration number 9615010 when referencing this establishment in official correspondence.