Data / Medical devices / Germany / Carl Zeiss Vision GMBH

Carl Zeiss Vision GMBH: FDA-registered device maker in AALEN Baden-Wurttemberg, Germany, 5 510(k) clearances

Name: Carl Zeiss Vision GMBH FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Carl Zeiss Vision GMBH is registered with the FDA (registration 9617474) in AALEN Baden-Wurttemberg, Germany. It lists 17 device types. The FDA files 5 510(k) clearances under its listings, the newest dated March 18, 2026. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Carl Zeiss Vision GMBH

FDA registration number: 9617474
FEI number: 3002398337
Address: Turnstrasse 27, AALEN Baden-Wurttemberg, Germany, 73430
Owner or operator: CARL ZEISS VISION INC. (9072118)
Roles: Complaint file establishment, Exporter to the US, Manufacturer, Specification developer
First device listed: June 16, 1992
Registered through: 2026
Brand names listed: 1.5, 1.53, 1.67 Optics, 1.74, ATLAS Review for i.Profiler plus, CARL ZEISS VISION LENS, Chair & Stand, Low - vision and more

Devices it lists

Device	Product code	Class	Role	Source
Biomicroscope, Slit-Lamp, Ac-Powered	HJO	2	Complaint file establishment, Exporter to the US, Specification developer	accessdata.fda.gov
Camera, Ophthalmic, Ac-Powered	HKI	2	Exporter to the US	accessdata.fda.gov
Chair, Ophthalmic, Ac-Powered	HME	1	Exporter to the US	accessdata.fda.gov
Chart, Visual Acuity	HOX	1	Manufacturer	accessdata.fda.gov
Distometer	HMM	1	Manufacturer	accessdata.fda.gov
Frame, Spectacle	HQZ	1	Manufacturer	accessdata.fda.gov
Instrument, Measuring, Lens, Ac-Powered	HLM	1	Exporter to the US	accessdata.fda.gov
Lens, Spectacle, Non-Custom (Prescription)	HQG	1	Manufacturer, Specification developer	accessdata.fda.gov
Medical Device Data System	OUG	1	Manufacturer	accessdata.fda.gov
Pupillometer, Ac-Powered	HLG	1	Manufacturer	accessdata.fda.gov
Refractometer, Ophthalmic	HKO	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Refractor, Manual, Non-Powered, Including Phoropter	HKN	1	Exporter to the US	accessdata.fda.gov
Stand, Instrument, Ac-Powered, Ophthalmic	HMF	1	Manufacturer	accessdata.fda.gov
Sunglasses (Non-Prescription Including Photosensitive)	HQY	1	Manufacturer	accessdata.fda.gov
Table, Instrument, Powered, Ophthalmic	HRJ	1	Exporter to the US	accessdata.fda.gov
Telescope, Spectacle, Low-Vision	HKK	1	Complaint file establishment, Exporter to the US, Manufacturer	accessdata.fda.gov
Tonometer, Ac-Powered	HKX	2	Exporter to the US	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 18, 2026	K253834	VISUREF 600	HJO	Substantially Equivalent	Carl Zeiss Vision GmbH	accessdata.fda.gov
January 29, 2021	K202221	VX650	HKI	Substantially Equivalent	Luneau Technology Operations	accessdata.fda.gov
December 18, 2013	K132186	OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2	HKI	Substantially Equivalent	Optomed OY	accessdata.fda.gov
January 20, 2004	K032799	NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER	HKX	Substantially Equivalent	Reichert, Inc.	accessdata.fda.gov
September 9, 1993	K925641	ZEISS 20 SL SLIT-LAMP & MECHANICAL MICROMANIPULATR	HJO	Substantially Equivalent	Carl Zeiss, Inc.	accessdata.fda.gov

Compare with other makers

Updated March 18, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.