CARL ZEISS MEDITEC AG (JENA)

FDA Device Registration & Listing · JENA Thuringia, DE · Registration 3038356864

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3038356864
FEI Number
3038356864
Entity Name
CARL ZEISS MEDITEC AG (JENA)
City/State/Country
JENA Thuringia, DE
Establishment Address
Goeschwitzer Strasse 51-52, JENA Thuringia 07745, DE
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
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
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

VISUPLAN 500 VISULAS Trion VISULAS Trion Laser System with the VITE Option VISUREF 150 WASCA Analyzer VISUREF 100 (URK-800) FORUM GLAUCOMA WORKPLACE IOLMaster 500 CALLISTO eye IOL Master 700 IOLMASTER 500 VISULAS combi VISULAS green (classic and comfort) MEL 80 EXCIMER LASER SYSTEM MEL 90 VISULAS yag VISUPAC 481 FF450 Plus VISUPAC System ZEISS Slit Lamp SL 115 ZEISS Slit Lamp SL 120 ZEISS Slit Lamp HSO 10 ZEISS 20 SL Slit Lamp and Mechanical Micromanipulator FORUM Archive and Viewer FORUM Archive IOLMaster 700 (TK) Indirect Ophthalmoscope SL 115, SL 120, SL cam 5 Digital Imaging VISULAS YAG III CIRRUS Photo Models 600 and 800 VISUCAM C Digital Camera VISULAS 532s Laser System with the VITE Option VISUSCREEN 100/500 VISULAS 532s Visulas YAG II Plus Ophthalmic Laser Ophthalmic TRENION 3D HD MEDIALINK 100 EDIS / IDIS VISUConnect500 VISUHEALTH VERACITY surgical SL Imaging Solution IOLMASTER 500 with Option Reference Image IOLMASTER 500 with Reference Image mode Zeiss Cataract Suite Markerless VISULAS green SL 800 Sl 200 i.Profiler Plus ATLAS 500 EyeMag Light II IOL Master Zeiss 30 SL-L Zeiss Slit Lamp SL 130 VisuMax Laser Keratome ZEISS VISULAS YAG II Laser FORUM Archive and Viewer FORUM Assist match FORUM Archive CALLISTO eye VISUCAM Pro NM FAF VISUCAM 224 VISUCAM 524 VISUCAM NM/FA FAF VISUCAM NM/FA VISUCAM ProNM FORUM Viewer App

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HKX Tonometer, Ac-Powered Ophthalmic Class 2 886.1930 2014-10-09
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2008-06-12
HQF Laser, Ophthalmic Ophthalmic Class 2 886.4390 2011-02-18
HKO Refractometer, Ophthalmic Ophthalmic Class 1 886.1760 2006-01-31
NFJ System, Image Management, Ophthalmic Radiology Class 2 892.2050 2016-02-08
HJO Biomicroscope, Slit-Lamp, Ac-Powered Ophthalmic Class 2 886.1850 2010-11-04
NFJ System, Image Management, Ophthalmic Radiology Class 2 892.2050 2023-08-30
HJO Biomicroscope, Slit-Lamp, Ac-Powered Ophthalmic Class 2 886.1850 2015-07-24
HJO Biomicroscope, Slit-Lamp, Ac-Powered Ophthalmic Class 2 886.1850 2015-12-11
HQF Laser, Ophthalmic Ophthalmic Class 2 886.4390 2024-09-11
HQF Laser, Ophthalmic Ophthalmic Class 2 886.4390 2019-03-08
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2019-03-08
LZS Excimer Laser System Unknown Class 3 N/A 2006-11-24
HQF Laser, Ophthalmic Ophthalmic Class 2 886.4390 2023-10-23
HKI Camera, Ophthalmic, Ac-Powered Ophthalmic Class 2 886.1120 2007-12-19
NFF Device, Storage, Images, Ophthalmic Radiology Class 1 892.2010 2007-12-19
NFG Device, Communications, Images, Ophthalmic Radiology Class 1 892.2020 2007-12-19
HJO Biomicroscope, Slit-Lamp, Ac-Powered Ophthalmic Class 2 886.1850 2008-04-09
NFJ System, Image Management, Ophthalmic Radiology Class 2 892.2050 2013-03-18
HJO Biomicroscope, Slit-Lamp, Ac-Powered Ophthalmic Class 2 886.1850 2018-08-30
HLJ Ophthalmoscope, Battery-Powered Ophthalmic Class 2 886.1570 2007-12-05
HJO Biomicroscope, Slit-Lamp, Ac-Powered Ophthalmic Class 2 886.1850 2014-03-26
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2007-12-19
HKI Camera, Ophthalmic, Ac-Powered Ophthalmic Class 2 886.1120 2014-07-29
OBO Tomography, Optical Coherence Ophthalmic Class 2 886.1570 2014-07-29
HKI Camera, Ophthalmic, Ac-Powered Ophthalmic Class 2 886.1120 2008-04-11
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2010-03-18
HOX Chart, Visual Acuity Ophthalmic Class 1 886.1150 2014-10-09
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2008-04-09
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2008-04-11
OUG Medical Device Data System General Hospital Class 1 880.6310 2011-07-18
HRM Microscope, Operating & Accessories, Ac-Powered, Ophthalmic General, Plastic Surgery Class 1 878.4700 2016-03-08
EPT Microscope, Surgical General, Plastic Surgery Class 1 878.4700 2016-03-08
HMR Marker, Ocular Ophthalmic Class 1 886.4570 2016-03-08
NFJ System, Image Management, Ophthalmic Radiology Class 2 892.2050 2016-03-08
HJO Biomicroscope, Slit-Lamp, Ac-Powered Ophthalmic Class 2 886.1850 2016-03-08
HQF Laser, Ophthalmic Ophthalmic Class 2 886.4390 2024-01-03
HJO Biomicroscope, Slit-Lamp, Ac-Powered Ophthalmic Class 2 886.1850 2017-06-05
MMQ Topographer, Corneal, Ac-Powered Ophthalmic Class 1 886.1350 2009-06-04
KYT Light, Examination, Medical, Battery Powered General Hospital Class 1 880.6350 2014-05-22
HJO Biomicroscope, Slit-Lamp, Ac-Powered Ophthalmic Class 2 886.1850 2007-12-19
HJO Biomicroscope, Slit-Lamp, Ac-Powered Ophthalmic Class 2 886.1850 2008-04-09
HNO Keratome, Ac-Powered Ophthalmic Class 1 886.4370 2010-08-11
HQF Laser, Ophthalmic Ophthalmic Class 2 886.4390 2010-08-11
HQF Laser, Ophthalmic Ophthalmic Class 2 886.4390 2008-04-11
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2008-04-11
NFJ System, Image Management, Ophthalmic Radiology Class 2 892.2050 2009-04-23
NFJ System, Image Management, Ophthalmic Radiology Class 2 892.2050 2024-06-04
HKI Camera, Ophthalmic, Ac-Powered Ophthalmic Class 2 886.1120 2008-04-11
NFG Device, Communications, Images, Ophthalmic Radiology Class 1 892.2020 2003-12-29

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
9615010 CARL ZEISS MEDITEC AG (OBERKOCHEN) OBERKOCHEN Baden-Wurttemberg, DE

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K870750 Keeler Instruments, Inc. KEELER PULSAIR NON CONTACT TONOMETER 1987-03-17
K083258 Dornier Medtech America, Inc. MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE 2009-01-30
K201111 Candela Corporation GentleMax Pro Plus 2020-05-26
K202758 Shangdong Huamei Technology Co., Ltd. Nd: YAG Laser Therapy Systems HM-YL900 2020-11-16
K904068 Luxar Corp. LUXAR MODEL LX-20 CO2 LASER 1991-04-15

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0005-2014 PhotoMedex, Inc. 2
The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018 Medtronic Navigation, Inc. 2
VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007 Lumenis Inc. 2
Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA
Z-0046-2014 Abbott Medical Optics, Inc. 3
STAR Excimer Laser System, Model: STAR S2, Catalog Number: 0030-1479, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations.
Z-0047-2014 Abbott Medical Optics, Inc. 3
STAR ActiveTrak Excimer Laser System, Model: STAR S3, Catalog Number: 0030-2450, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038356864. Last updated year: 2026. Please use registration number 3038356864 when referencing this establishment in official correspondence.
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