Data / Medical devices / United States / Optego Vision USA, Inc.

Optego Vision USA, Inc.: FDA-registered device maker in Tucson, AZ, United States, 1 510(k) clearance

Name: Optego Vision USA, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Optego Vision USA, Inc. is registered with the FDA (registration 2085143) in Tucson, AZ, United States. It lists 31 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 5, 2011. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 2085143
FEI number: 1000160574
Address: 4525 S. Coach Drive, Tucson, AZ, United States, 85714
Owner or operator: Optego Vision USA, Inc. (9044582)
Roles: Manufacturer, Repackager or relabeler, Specification developer
First device listed: September 5, 2003
Registered through: 2026
Brand names listed: CALIPER, CURETTE, Clear Vented Eye Shields, Contact Lens Removers, DISH, ECC Jeweler's Forceps #1, ECC Jeweler's Forceps #4, ECC Jeweler's Forceps #5 and more

Devices it lists

Device	Product code	Class	Role	Source
Caliper, Ophthalmic	HOE	1	Manufacturer, Specification developer	accessdata.fda.gov
Case, Contact Lens	LRX	2	Manufacturer	accessdata.fda.gov
Chart, Visual Acuity	HOX	1	Manufacturer	accessdata.fda.gov
Curette, Ophthalmic	HNZ	1	Manufacturer, Specification developer	accessdata.fda.gov
Dilator, Lachrymal	HNW	1	Specification developer	accessdata.fda.gov
Dish, Tissue Culture	KIZ	1	Manufacturer, Specification developer	accessdata.fda.gov
Epilator, High Frequency, Needle-Type	KCW	1	Manufacturer	accessdata.fda.gov
Forceps, Ophthalmic	HNR	1	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Frame, Trial, Ophthalmic	HPA	1	Repackager or relabeler	accessdata.fda.gov
Inserter/Remover Contact Lens	KYE	1	Manufacturer	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Measuring, Lens, Ac-Powered	HLM	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Measuring, Stereopsis	HLC	1	Manufacturer	accessdata.fda.gov
Knife, Ophthalmic	HNN	1	Specification developer	accessdata.fda.gov
Lens, Maddox	HKR	1	Repackager or relabeler	accessdata.fda.gov
Magnifier, Hand-Held, Low-Vision	HJF	1	Repackager or relabeler	accessdata.fda.gov
Prism, Bar, Ophthalmic	HKW	1	Manufacturer	accessdata.fda.gov
Prism, Fresnel, Ophthalmic	HKT	1	Manufacturer	accessdata.fda.gov
Probe, Lachrymal	HNL	1	Manufacturer, Specification developer	accessdata.fda.gov
Pupillometer, Manual	HLH	1	Repackager or relabeler	accessdata.fda.gov
Rack, Skiascopic	HMH	1	Manufacturer	accessdata.fda.gov
Scissors, Ophthalmic	HNF	1	Specification developer	accessdata.fda.gov
Set, Lens, Trial, Ophthalmic	HPC	1	Repackager or relabeler	accessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	HOY	1	Manufacturer	accessdata.fda.gov
Simulatan (Including Crossed Cylinder)	HOR	1	Repackager or relabeler	accessdata.fda.gov
Spectacle, Magnifying	HOI	1	Repackager or relabeler	accessdata.fda.gov
Specula, Ophthalmic	HNC	1	Manufacturer, Specification developer	accessdata.fda.gov
Spud, Ophthalmic	HNA	1	Manufacturer, Specification developer	accessdata.fda.gov
Strip, Schirmer	KYD	1	Manufacturer	accessdata.fda.gov
Sunglasses (Non-Prescription Including Photosensitive)	HQY	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 5, 2011	K112832	EYE CARE CURE CONTACT LENS CASE	LRX	Substantially Equivalent	Eye Care and Cure	accessdata.fda.gov

Compare with other makers

Updated December 5, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.