Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615030

FEI Number

3001362763

Entity Name

Carl Zeiss Meditec AG (Jena)

City/State/Country

Jena Thuringia, DE

Establishment Address

Carl-Zeiss-Promenade 10, Jena Thuringia 07745, 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

P060004

All Registered Proprietary Names

Retina Workplace VISULENS 500 VISULENS 550 Model 350, 355, 360 Humphrey Lens Analyzer Series VisuMax (HORUS) LASER KERATOME VISUCAM Pro NM FAF VISUCAM 224 VISUCAM 524 VISUCAM NM/FA FAF VISUCAM NM/FA VISUCAM ProNM ZEISS Slit Lamp SL 115 ZEISS Slit Lamp SL 120 ZEISS Slit Lamp HSO 10 ZEISS 20 SL Slit Lamp and Mechanical Micromanipulator VISULAS Trion Laser System with the VITE Option VISUREF 150 WASCA Analyzer VISUREF 100 (URK-800) Visulas YAG II Plus Ophthalmic Laser Ophthalmic ZEISS VISULAS Argon Laser VISULAS YAG III i.Profiler Plus ATLAS 500 IOLMaster 500 VISUPAC 481 FF450 Plus VISUPAC System IOL Master 700 CIRRUS photo Models 600 and 800 IOLMASTER 500 VISUCAM C Digital Camera IOLMASTER 500 with Option Reference Image IOLMASTER 500 with Reference Image mode Zeiss Cataract Suite Markerless SL 115, SL 120, SL cam 5 Digital Imaging Power Table Model AV 100 Power Table Model AV 220 Power Table Model HFA 230 Universal instrument table IT 760 Universal instrument table IT 760W.i Universal instrument table IT 1060.i Universal instrument table IT 1060 Universal instrument table IT 760.i Universal instrument table IT 760 W Power Table Model HFA 120 Power Table Model AV 120 Power Table Model HPT 120 Power Table Model CV-120 Power Table Model AV 240 Power Table Model CV-230 Power Table Model Stratus OCT ZEISS VISULAS YAG II Laser VISUSCREEN 100/500 VISULAS 532s Laser System with the VITE Option VisuScout 100 VISUPHOR 500 VISULAS Trion MEL 80 EXCIMER LASER SYSTEM MEL 90

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NFJ	System, Image Management, Ophthalmic	Radiology	Class 2	892.2050	2015-06-08
HLM	Instrument, Measuring, Lens, Ac-Powered	Ophthalmic	Class 1	886.1425	1992-10-02
HNO	Keratome, Ac-Powered	Ophthalmic	Class 1	886.4370	2007-05-15
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2007-05-15
HKI	Camera, Ophthalmic, Ac-Powered	Ophthalmic	Class 2	886.1120	2008-04-11
HJO	Biomicroscope, Slit-Lamp, Ac-Powered	Ophthalmic	Class 2	886.1850	2008-04-09
HQF	Laser, Ophthalmic	Ophthalmic	Class 2	886.4390	2011-02-18
HKO	Refractometer, Ophthalmic	Ophthalmic	Class 1	886.1760	2006-01-31
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2008-04-11
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	2007-12-19
MMQ	Topographer, Corneal, Ac-Powered	Ophthalmic	Class 1	886.1350	2009-06-04
HJO	Biomicroscope, Slit-Lamp, Ac-Powered	Ophthalmic	Class 2	886.1850	2010-11-04
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	2015-07-24
HKI	Camera, Ophthalmic, Ac-Powered	Ophthalmic	Class 2	886.1120	2012-10-19
OBO	Tomography, Optical Coherence	Ophthalmic	Class 2	886.1570	2012-10-19
HJO	Biomicroscope, Slit-Lamp, Ac-Powered	Ophthalmic	Class 2	886.1850	2015-12-11
HKI	Camera, Ophthalmic, Ac-Powered	Ophthalmic	Class 2	886.1120	2008-04-11
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
HJO	Biomicroscope, Slit-Lamp, Ac-Powered	Ophthalmic	Class 2	886.1850	2014-03-26
HRJ	Table, Instrument, Powered, Ophthalmic	Ophthalmic	Class 1	886.4855	2013-01-21
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
HOX	Chart, Visual Acuity	Ophthalmic	Class 1	886.1150	2014-10-09
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2010-03-18
HKI	Camera, Ophthalmic, Ac-Powered	Ophthalmic	Class 2	886.1120	2018-01-11
HKN	Refractor, Manual, Non-Powered, Including Phoropter	Ophthalmic	Class 1	886.1770	2014-09-24
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2008-06-12
LZS	Excimer Laser System	Unknown	Class 3	N/A	2006-11-24

Official Correspondent

Carl ZEISS Meditec AG (Jena)

US Agent Details

Paul Swift Business: CARL ZEISS MEDITEC, 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
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
K142225	CAO Group, Inc.	Pilot Elite Diode Laser	2014-09-12

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, PASLT Fiber Delivery SystemSterileNon-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-0009-2018	Optovue, Inc.	2	iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic conditions. The iCam takes digital images of the posterior and external structures of the eye without the use of a mydriatic agent and is intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health. iCam provides images only and does not provide any diagnostic, pathological analysis or classification of ocular health or disease. AND iVue with Normative Database (K121739) - The iVue is a noncontact, high resolution optical coherence tomography system intended for in vivo imaging, axial cross-sectional, three-dimensional imaging and measurement of anterior and posterior. ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects.
Z-0024-2013	Optovue Inc.	2	Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.

Similar Registrations

Registration Number	Establishment Name	Location
3011520729	INTELLIGENT RETINAL IMAGING SYSTEMS, INC.	Pensacola, FL, US
3008729548	Topcon Yamagata Co., LTD	Yamagata-KEN, JP
1000181430	CANON INC.	Kawasaki Kanagawa, JP
9617167	OPTOS PLC	DUNFERMLINE, FIFE, GB
3014655548	OPHTHALMIC LABS, INC.	Milton, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615030. Last updated year: 2026. Please use registration number 9615030 when referencing this establishment in official correspondence.