Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1041845

FEI Number

1041845

Entity Name

Lombart Instrument, Inc. d/b/a Marco Ophthalmic

City/State/Country

Jacksonville, FL, US

Establishment Address

11825 CENTRAL PKWY., Jacksonville, FL 32224, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Lombart Instrument, Inc. d/b/a Marco Ophthalmic (Owner Number: 1041845)

Owner / Operator Contact Address

11825 CENTRAL PKWY., --, Jacksonville, FL 32224, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Marco Ion Brightness Acuity Tester

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PJZ	Camera, Ophthalmic, General-Use	Ophthalmic	Class 2	886.1120	2026-02-05
HOX	Chart, Visual Acuity	Ophthalmic	Class 1	886.1150	2008-03-12

Official Correspondent

Rich Wynkoop

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Lombart Instrument, Inc. d/b/a Marco Ophthalmic

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1041845. Last updated year: 2026. Please use registration number 1041845 when referencing this establishment in official correspondence.