Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005641545

FEI Number

3005641545

Entity Name

NOVA EYE INC.

City/State/Country

Fremont, CA, US

Establishment Address

41316 Christy St, Fremont, CA 94538, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Nova Eye Medical Ltd (Owner Number: 10075633)

Owner / Operator Contact Address

107 Rundle Street, Kent Town, AU-SA 5067, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K080067

PMA Number

N/A

All Registered Proprietary Names

iTrack Advance Viscoinjector Canaloplasty Microcather iTrack 250A

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MPA	Endoilluminator	Gastroenterology, Urology	Class 2	876.1500	2023-04-03
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2023-04-03
MRH	Pump, Infusion, Ophthalmic	General Hospital	Class 2	880.5725	2020-06-22
MPA	Endoilluminator	Gastroenterology, Urology	Class 2	876.1500	2020-06-22
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2020-06-22

Official Correspondent

Don Watton

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Nova Eye Medical Ltd

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K854401	Microsurgical Technology, Inc.	THE NEW MOBILE TIP MCINTYRE CANNULA	1985-12-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0011-2019	Ellex iScience, Inc.	1	ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
Z-0307-2026	Alcon Research LLC	2	Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000252 UNITY 27 GA CHANDELIER 8065000253 UNITY 27+DS WIDE ANGLE LIGHT PROBE Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A
Z-0022-2009	Becton Dickinson and Company	1	BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.

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3005941719	Sterigenics Belgium Petit Rechain S.A.	Verviers Liege, BE
3019810045	Oculight Co.,Ltd.	Seongnam, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005641545. Last updated year: 2026. Please use registration number 3005641545 when referencing this establishment in official correspondence.