Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2086350

FEI Number

3003615773

Entity Name

FRESNEL PRISM & LENS CO.

City/State/Country

Bloomington, MN, US

Establishment Address

10810 NESBITT AVE S, Bloomington, MN 55437, US

Establishment Type(s)

Manufacture Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

THE FRESNEL PRISM AND LENS COMPANY (Owner Number: 9032895)

Owner / Operator Contact Address

10810 Nesbitt Ave. S., --, Bloomington, MN 55437, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CoverClude Occlusion Eye Patch Vision Screening Patch MYI Occlusion Eye Patches MIN Occlusion Lens Bangerter Occlusion Foil Bar D Segment of 3M Press On Fresnel Lens Fresnel Prism Trial Sets

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2004-02-04
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2019-05-03
NXR	Fixation, Vision Training, Binocular	Ophthalmic	Class 1	886.1290	2019-05-03
HKT	Prism, Fresnel, Ophthalmic	Ophthalmic	Class 1	886.1655	2001-07-24
HPC	Set, Lens, Trial, Ophthalmic	Ophthalmic	Class 1	886.1405	2008-07-25

Official Correspondent

Kathy Armstrong

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

THE FRESNEL PRISM AND LENS COMPANY

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
K910951	United Optical, Spa	OPTHLAMIC FRAMES	1991-05-06
K900478	Woodlyn, Inc.	WOODLYN FULL APERTURE TRIAL LENS SET	1990-02-21

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2086350. Last updated year: 2026. Please use registration number 2086350 when referencing this establishment in official correspondence.