Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011589232

FEI Number

3011589232

Entity Name

Carl ZEISS Vision Inc. - USRX-SC

City/State/Country

Saint Cloud, MN, US

Establishment Address

4605 Rusan St, Saint Cloud, MN 56303, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CARL ZEISS VISION INC. (Owner Number: 9086547)

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

Carl Zeiss Vision GT2 ClearMind ZEISS ZEISS Optical Insert- Prescription ZEISS Optical Insert - Demo ZEISS Optical Insert Light PerformaSun DriveSafe ClearView PhotoFusion Performance HDV CleanGuard Ultra HDV UVProtect SmartLife Synchrony Ultra HD DuraVision Performance HD ZEISS Optical Insert- Reader BlueGuard Experience 4K

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2009-06-30
HQG	Lens, Spectacle, Non-Custom (Prescription)	Ophthalmic	Class 1	886.5844	2003-03-18

Official Correspondent

Jahmal Cannon

US Agent Details

No US Agent registered (Local establishment).

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
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
3003344414	CARL ZEISS VISION SUNLENS ASIA PACIFIC LTD.	Guangzhou Guangdong, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K910951	United Optical, Spa	OPTHLAMIC FRAMES	1991-05-06

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3009554831	ROGER EYE DESIGN	Etten-Leur Noord-Brabant, NL
3013507321	DEM FACTORY S.R.L.	Limana Belluno, IT
3015243992	L.G.R SRL	Roma, IT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011589232. Last updated year: 2026. Please use registration number 3011589232 when referencing this establishment in official correspondence.