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Data / Medical devices / United States / Alcon Vision, LLC

Alcon Vision, LLC: FDA-registered device maker in Elkridge, MD, United States, 1 510(k) clearance

Alcon Vision, LLC is registered with the FDA (registration 1121203) in Elkridge, MD, United States. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 29, 1988. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
1121203
FEI number
3000215259
Address
6740 Business parkway, Elkridge, MD, United States, 21075
Owner or operator
Alcon Laboratories, Inc. (1610287)
Roles
Repackager or relabeler
First device listed
December 13, 2007
Registered through
2026

Devices it lists

DeviceProduct codeClassRoleSource
Eye TrayOJK2Repackager or relabeleraccessdata.fda.gov
General Surgery TrayLRO2Repackager or relabeleraccessdata.fda.gov
Iol TrayQDV1Repackager or relabeleraccessdata.fda.gov
Phaco KitQDW2Repackager or relabeleraccessdata.fda.gov
Surgical Eye TrayPZG1Repackager or relabeleraccessdata.fda.gov
Vitrectomy KitQDY2Repackager or relabeleraccessdata.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
April 29, 1988K880961ALCON SURGICAL PROCEDURE PACKSLROSubstantially EquivalentAlcon Laboratoriesaccessdata.fda.gov

Compare with other makers

Updated April 29, 1988. 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.