OCULUS Florida Service Center

FDA Device Registration & Listing · Port Saint Lucie, FL, US · Registration 3020723591

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3020723591
FEI Number
3020723591
Entity Name
OCULUS Florida Service Center
City/State/Country
Port Saint Lucie, FL, US
Establishment Address
562 NW Mercantile Pl Ste 104, Port Saint Lucie, FL 34986, 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
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Hubtische Ophthalmic table Corvis STL Frame, Trial, Ophthalmic Exophthalmometer Vissard 3D, Vissard MOBIL Vissard RG LidStick Myopia Master MAGNIFYING SPECTACLE Binoptometer Binoptometer 4P Pentacam Pentacan HR ImageCam 3 Set, Lens, Trial Keratograph 5M Easygraph Keratograph Pentacam AXL Lens, Bagolini Anomaloscope Easyfield C Easyfield S Smartfield Centerfield 2 Twinfield 3 Pentacam Cornea OCT Color Vision Tester C-Quant

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
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
HPA Frame, Trial, Ophthalmic Ophthalmic Class 1 886.1415 1978-04-20
HLS Exophthalmometer Ophthalmic Class 1 886.1270 1978-04-20
HLG Pupillometer, Ac-Powered Ophthalmic Class 1 886.1700 2016-09-05
HNI Retractor, Ophthalmic Ophthalmic Class 1 886.4350 2020-11-09
MXK Device, Analysis, Anterior Segment Ophthalmic Class 2 886.1850 2021-07-22
HOI Spectacle, Magnifying Ophthalmic Class 1 886.5840 1978-04-20
HJQ Stereoscope, Ac-Powered Ophthalmic Class 1 886.1870 2013-09-07
MXK Device, Analysis, Anterior Segment Ophthalmic Class 2 886.1850 2010-06-08
KQM Camera, Surgical And Accessories General, Plastic Surgery Class 1 878.4160 2013-08-27
HPC Set, Lens, Trial, Ophthalmic Ophthalmic Class 1 886.1405 1978-04-20
MMQ Topographer, Corneal, Ac-Powered Ophthalmic Class 1 886.1350 2000-07-11
MXK Device, Analysis, Anterior Segment Ophthalmic Class 2 886.1850 2016-01-29
HPD Lens, Bagolini Ophthalmic Class 1 886.1375 1978-04-20
HIW Anomaloscope Ophthalmic Class 1 886.1070 2011-08-16
HOO Perimeter, Ac-Powered Ophthalmic Class 1 886.1605 1978-04-20
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
HIT Tester, Color Vision Ophthalmic Class 1 886.1170 2011-08-26

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
3033566 OCULUS, INC. Arlington, WA, 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

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020723591. Last updated year: 2026. Please use registration number 3020723591 when referencing this establishment in official correspondence.
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