Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9617474

FEI Number

3002398337

Entity Name

CARL ZEISS VISION GMBH

City/State/Country

AALEN Baden-Wurttemberg, DE

Establishment Address

Turnstrasse 27, AALEN Baden-Wurttemberg 73430, DE

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

CARL ZEISS VISION INC. (Owner Number: 9072118)

Owner / Operator Contact Address

1040 Worldwide Blvd, Hebron, KY 41048, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

VISU360 VISUCONSULT 500 ATLAS Review for i.Profiler plus ZEISS SUNGLASSES VISUSCREEN 500 VISUSCREEN 100 VISUSCREEN 100 Compact CARL ZEISS VISION LENS ZEISS SPECTACLE LENSES ZEISS Single Vision Individual 1.5 1.53 1.67 Optics ZEISS Optical Insert 1.74 i.Terminal go i.Terminal Mobile VISUFIT 1000 i.Terminal 2 VISUPHOR 500 VISUCORE 500 Table VISUREF 600 i.Terminal 2 Station VISUFIT 1000 Platform VISUREF 150 i.Profiler plus VISUREF VISUCORE 500 Refractor Low - vision

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2017-12-19
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	1992-06-16
HOX	Chart, Visual Acuity	Ophthalmic	Class 1	886.1150	1999-01-21
HQG	Lens, Spectacle, Non-Custom (Prescription)	Ophthalmic	Class 1	886.5844	2006-04-21
HMM	Distometer	Ophthalmic	Class 1	886.1190	2012-02-21
HKN	Refractor, Manual, Non-Powered, Including Phoropter	Ophthalmic	Class 1	886.1770	2019-03-21
HRJ	Table, Instrument, Powered, Ophthalmic	Ophthalmic	Class 1	886.4855	2023-06-02
HJO	Biomicroscope, Slit-Lamp, Ac-Powered	Ophthalmic	Class 2	886.1850	2026-03-19
HMF	Stand, Instrument, Ac-Powered, Ophthalmic	Ophthalmic	Class 1	886.1860	2020-02-19
HKO	Refractometer, Ophthalmic	Ophthalmic	Class 1	886.1760	2013-06-27
HKK	Telescope, Spectacle, Low-Vision	Ophthalmic	Class 1	886.5870	1999-01-21

Official Correspondent

Jahmal Cannon

US Agent Details

Jahmal Cannon Business: Carl Zeiss Vision Inc. Email: jahmal.cannon@zeiss.com Phone: (423) 5982680

Related Public Records

Same Entity

CARL ZEISS VISION INC.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007675955	Carl Zeiss Vision Canada, Inc.	Toronto Ontario, CA
3011589232	Carl ZEISS Vision Inc. - USRX-SC	Saint Cloud, MN, US
1000253285	CARL ZEISS VISION MANUFACTURA DE MEXICO, S. DE R.L	TIJUANA Baja California, MX
9616418	CARL ZEISS VISION (CHINA) LTD.	GUANGZHOU, GUANGDONG, CN
3003461935	CARL ZEISS VISION ITALIA S.P.A.	CASTIGLIONE OLONA Varese, IT

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K940726	Jay-Y Enterprises Co., Inc.	NONE-GENERIC	1994-04-11
K934837	Simon Marketing, Inc.	SUNGLASSES	1993-12-08
K852902	Yours Enterprise Co., Ltd.	METALLIC SUNGLASSES	1985-08-12
K970895	Custom Optical Frames, Inc.	CUSTOM OPTICAL SUNGLASS FRAMES	1997-05-06
K853921	Winsburn Company , Ltd.	ALL KINDS OF SUNGLASSES	1985-10-15

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3002725312	AMERICAN PORTWELL TECHNOLOGY, INC.	Fremont, CA, US
3007832484	JWP MANUFACTURING	Santa Clara, CA, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9617474. Last updated year: 2026. Please use registration number 9617474 when referencing this establishment in official correspondence.