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Data / Medical devices / United States / Veo Ophthalmics LLC

Veo Ophthalmics LLC: FDA-registered device maker in West Chester, OH, United States, 1 510(k) clearance and 1 PMA approval

Veo Ophthalmics LLC is registered with the FDA (registration 3014399865) in West Chester, OH, United States. It lists 4 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated July 24, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3014399865
Address
10184 International Boulevard, West Chester, OH, United States, 45246
Owner or operator
VEO Ophthalmics LLC (10058391)
Roles
Complaint file establishment
First device listed
December 27, 2022
Registered through
2026
Brand names listed
CUSTOMFLEX ARTIFICIAL IRIS, Plexitome, QuickSet TKP™, VisionOne

Devices it lists

DeviceProduct codeClassRoleSource
Artificial IrisQBT3Complaint file establishmentaccessdata.fda.gov
CystotomeHNY1Complaint file establishmentaccessdata.fda.gov
Keratoprosthesis, Temporary Implant, Surgical UseMLP2Complaint file establishmentaccessdata.fda.gov
Perimeter, Automatic, Ac-PoweredHPT1Complaint file establishmentaccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
July 24, 2026K261312Temporary Keratoprosthesis (QuickSet TKP™)MLPSubstantially EquivalentEyekon Medical, Inc.accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
May 30, 2018P170039CustomFlex Artificial IrisQBT3September 4, 2020accessdata.fda.gov

Compare with other makers

Updated July 24, 2026. 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.