Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2085143

FEI Number

1000160574

Entity Name

Optego Vision USA, Inc.

City/State/Country

Tucson, AZ, US

Establishment Address

4525 S. Coach Drive, Tucson, AZ 85714, US

Establishment Type(s)

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

Owner / Operator

Optego Vision USA, Inc. (Owner Number: 9044582)

Owner / Operator Contact Address

4525 S. Coach Drive, --, Tucson, AZ 85714, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Optego Fresnel Prism Optego Prism MASTER AID TAPE CALIPER Ophthalmic Knife EpiGlare School Bus Retinoscopy Rack CURETTE Magnifiers MADDOX Karickoff Strips Lacrimal Dilator SPECULA TRIAL SPUD PUPILLOMETER Pro Lectro Ophthalmic scissors DISH TISSUE CULTURE HAND-HELD MAGNIFIER LOW-VISION Loose Prism Block Worthmore Post Mydriatic Spectacles Clear Vented Eye Shields Eye Patch PROBE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HKT	Prism, Fresnel, Ophthalmic	Ophthalmic	Class 1	886.1655	2020-03-15
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2003-09-05
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2007-08-01
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2007-08-27
HOX	Chart, Visual Acuity	Ophthalmic	Class 1	886.1150	2020-01-10
HMH	Rack, Skiascopic	Ophthalmic	Class 1	886.1750	2020-01-10
HNZ	Curette, Ophthalmic	Ophthalmic	Class 1	886.4350	2007-08-01
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	2007-05-14
HKR	Lens, Maddox	Ophthalmic	Class 1	886.1400	2007-05-14
KYD	Strip, Schirmer	Ophthalmic	Class 1	886.1800	2020-01-10
HNW	Dilator, Lachrymal	Ophthalmic	Class 1	886.4350	2007-08-01
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	2007-08-01
HPA	Frame, Trial, Ophthalmic	Ophthalmic	Class 1	886.1415	2007-05-14
HNA	Spud, Ophthalmic	Ophthalmic	Class 1	886.4350	2007-08-01
HLH	Pupillometer, Manual	Ophthalmic	Class 1	886.1700	2007-05-14
KCW	Epilator, High Frequency, Needle-Type	General, Plastic Surgery	Class 1	878.5350	2011-03-11
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2007-08-01
KIZ	Dish, Tissue Culture	Hematology	Class 1	864.2240	2007-08-27
HJF	Magnifier, Hand-Held, Low-Vision	Ophthalmic	Class 1	886.5540	2007-05-14
HKW	Prism, Bar, Ophthalmic	Ophthalmic	Class 1	886.1650	2020-01-10
HLC	Instrument, Measuring, Stereopsis	Ophthalmic	Class 1	886.1460	2009-01-16
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2009-01-16
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	2007-08-01

Official Correspondent

JOHAN VAN DALEN

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Optego Vision USA, Inc.

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
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04
K874057	Myocure, Inc.	OPHTHALMIC TIP & BLADE SCALPELS	1987-12-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0026-04	Surgical Specialties Corp	1	Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives.
Z-1922-2024	Alcon Research LLC Aspex Facility	1	20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Z-1923-2024	Alcon Research LLC Aspex Facility	1	ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1924-2024	Alcon Research LLC Aspex Facility	1	ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1925-2024	Alcon Research LLC Aspex Facility	1	ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2085143. Last updated year: 2026. Please use registration number 2085143 when referencing this establishment in official correspondence.