Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611269

FEI Number

3002807782

Entity Name

OCULUS OPTIKGERATE GMBH

City/State/Country

WETZLAR Hesse, DE

Establishment Address

MUNCHHOLZHAUSER STR. 29, WETZLAR Hesse D-35582, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

OCULUS OPTIKGERATE GMBH (Owner Number: 8010318)

Owner / Operator Contact Address

Muenchholzhaeuser Str. 29, --, WETZLAR, DE-NOTA D-35582, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Keratograph 5M Easygraph Keratograph BINOCULAR INDIRECT OPHTHALMO MICROS STEREO DIAGNOSTIC INVERTER SDI 4 BIOM 6 BIOM 5 Hubtische Ophthalmic table Corvis STL Color Vision Tester C-Quant Set, Lens, Trial BIOM 6 Optic Set Versa HD Disposable LenZ Lens Ophthalmic, Reduction lens, Optic Set HD HD Disposable LenZ BIOM Optic Set Lens Set for HAAG-STREIT EIBOS 2 & Leica RUV800 BIOM ready BIOM Versa Optic Set BIOM ready+ ImageCam 3 Pentacam Pentacan HR Exophthalmometer Pentacam AXL Easyfield C Easyfield S Smartfield Centerfield 2 Twinfield 3 Lens, Bagolini

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MMQ	Topographer, Corneal, Ac-Powered	Ophthalmic	Class 1	886.1350	2000-07-11
HRM	Microscope, Operating & Accessories, Ac-Powered, Ophthalmic	General, Plastic Surgery	Class 1	878.4700	2004-04-26
HRJ	Table, Instrument, Powered, Ophthalmic	Ophthalmic	Class 1	886.4855	2013-09-07
HKX	Tonometer, Ac-Powered	Ophthalmic	Class 2	886.1930	2012-12-19
MXK	Device, Analysis, Anterior Segment	Ophthalmic	Class 2	886.1850	2012-12-19
HIT	Tester, Color Vision	Ophthalmic	Class 1	886.1170	2011-08-26
HPC	Set, Lens, Trial, Ophthalmic	Ophthalmic	Class 1	886.1405	1978-04-20
HOH	Spectacle, Operating (Loupe), Ophthalmic	Ophthalmic	Class 1	886.4770	1986-06-09
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2013-08-27
MXK	Device, Analysis, Anterior Segment	Ophthalmic	Class 2	886.1850	2010-06-08
HLS	Exophthalmometer	Ophthalmic	Class 1	886.1270	1978-04-20
MXK	Device, Analysis, Anterior Segment	Ophthalmic	Class 2	886.1850	2016-01-29
HOO	Perimeter, Ac-Powered	Ophthalmic	Class 1	886.1605	1978-04-20
HPD	Lens, Bagolini	Ophthalmic	Class 1	886.1375	1978-04-20

Official Correspondent

No official correspondent registered.

US Agent Details

Michael Krakowiecki Business: OCULUS Surgical, Inc Email: m.krakowiecki@oculussurgical.com Phone: (425) 6709977

Related Public Records

Same Entity

OCULUS OPTIKGERATE GMBH

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3033566	OCULUS, INC.	Arlington, WA, US
3020723591	OCULUS Florida Service Center	Port Saint Lucie, FL, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K870750	Keeler Instruments, Inc.	KEELER PULSAIR NON CONTACT TONOMETER	1987-03-17
K900478	Woodlyn, Inc.	WOODLYN FULL APERTURE TRIAL LENS SET	1990-02-21

Similar Registrations

Registration Number	Establishment Name	Location
3043625014	AI4EYES MEDICAL TECHNOLOGIES, INC.	Saint-Laurent Quebec, CA
3007177447	HITTECH MULTIN BV	Den Haag Zuid-Holland, NL
3003288808	WAVELIGHT GmbH	PRESSATH Bavaria, DE
1000391004	KEELER LTD.	WINDSOR, BERKSHIRE Windsor and Maidenhead, GB
3021343245	SHENZHEN CERTAINN TECHNOLOGY CO., LTD.	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611269. Last updated year: 2026. Please use registration number 9611269 when referencing this establishment in official correspondence.