Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033566

FEI Number

3002785343

Entity Name

OCULUS, INC.

City/State/Country

Arlington, WA, US

Establishment Address

17721 59th Avenue NE, Arlington, WA 98223, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

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

Myopia Master Easyfield VR Set, Lens, Trial Frame, Trial, Ophthalmic Pentacam AXL MAGNIFYING SPECTACLE Easyfield C Easyfield S Smartfield Centerfield 2 Twinfield 3 Perimeter Easyfield C Twinfield 3 Easyfield S Smartfield Centerfield 2 Color Vision Tester C-Quant Lens, Bagolini Anomaloscope Pentacam Cornea OCT Binoptometer Binoptometer 4P Vissard 3D, Vissard MOBIL Vissard RG ImageCam 3

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MXK	Device, Analysis, Anterior Segment	Ophthalmic	Class 2	886.1850	2021-07-22
HOS	Projector, Ophthalmic	Ophthalmic	Class 1	886.1680	2023-09-26
HPC	Set, Lens, Trial, Ophthalmic	Ophthalmic	Class 1	886.1405	1978-04-20
HPA	Frame, Trial, Ophthalmic	Ophthalmic	Class 1	886.1415	1978-04-20
MXK	Device, Analysis, Anterior Segment	Ophthalmic	Class 2	886.1850	2016-01-29
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	1978-04-20
HOO	Perimeter, Ac-Powered	Ophthalmic	Class 1	886.1605	1978-04-20
HPT	Perimeter, Automatic, Ac-Powered	Ophthalmic	Class 1	886.1605	2000-07-11
HIT	Tester, Color Vision	Ophthalmic	Class 1	886.1170	2011-08-26
HPD	Lens, Bagolini	Ophthalmic	Class 1	886.1375	1978-04-20
HIW	Anomaloscope	Ophthalmic	Class 1	886.1070	2011-08-16
OBO	Tomography, Optical Coherence	Ophthalmic	Class 2	886.1570	2026-03-25
MXK	Device, Analysis, Anterior Segment	Ophthalmic	Class 2	886.1850	2026-03-25
HJQ	Stereoscope, Ac-Powered	Ophthalmic	Class 1	886.1870	2013-09-07
HLG	Pupillometer, Ac-Powered	Ophthalmic	Class 1	886.1700	2016-09-05
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2013-08-27

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
9611269	OCULUS OPTIKGERATE GMBH	WETZLAR Hesse, DE
3020723591	OCULUS Florida Service Center	Port Saint Lucie, FL, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K900478	Woodlyn, Inc.	WOODLYN FULL APERTURE TRIAL LENS SET	1990-02-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
3020723591	OCULUS Florida Service Center	Port Saint Lucie, FL, US
3008729548	Topcon Yamagata Co., LTD	Yamagata-KEN, JP
1920664	Bausch & Lomb Incorporated	Saint Louis, MO, US
8020986	C.S.O. S.R.L.	Scandicci Firenze, IT
3004858034	ZIEMER OPHTHALMIC SYSTEMS AG	PORT Bern, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033566. Last updated year: 2026. Please use registration number 3033566 when referencing this establishment in official correspondence.