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

Alcon Research, LLC: FDA-registered device maker in Lake Forest, CA, United States, 18 510(k) clearances and 1 PMA approval

Alcon Research, LLC is registered with the FDA (registration 3010208880) in Lake Forest, CA, United States. It lists 22 device types. The FDA files 18 510(k) clearances and 1 PMA approval under its listings, the newest dated April 7, 2026. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Alcon Research, LLC
FDA registration number
3010208880
Address
20511 Lake Forest Dr, Lake Forest, CA, United States, 92630
Owner or operator
Alcon Laboratories, Inc. (1610287)
Roles
Specification developer
First device listed
February 3, 1994
Registered through
2026

Devices it lists

DeviceProduct codeClassRoleSource
Aberrometer, OphthalmicNCF1Specification developeraccessdata.fda.gov
Apparatus, Cautery, Radiofrequency, Ac-PoweredHQR2Specification developeraccessdata.fda.gov
Camera, Cine, Microsurgical, Without AudioFWJ1Specification developeraccessdata.fda.gov
Cannula, OphthalmicHMX1Specification developeraccessdata.fda.gov
Cannula, Trocar, OphthalmicNGY1Specification developeraccessdata.fda.gov
Catheter, IrrigationGBX1Specification developeraccessdata.fda.gov
Device, Irrigation, Ocular SurgeryKYG1Specification developeraccessdata.fda.gov
Drape, Surgical, ExemptPUI2Specification developeraccessdata.fda.gov
EndoilluminatorMPA2Specification developeraccessdata.fda.gov
Eyelid Thermal Pulsation SystemORZ2Specification developeraccessdata.fda.gov
Instrument, Vitreous Aspiration And Cutting, Ac-PoweredHQE2Specification developeraccessdata.fda.gov
Intraocular Pressure Lowering ImplantOGO3Specification developeraccessdata.fda.gov
Keratome, Ac-PoweredHNO1Specification developeraccessdata.fda.gov
Laser, OphthalmicHQF2Specification developeraccessdata.fda.gov
Lens, Guide, IntraocularKYB1Specification developeraccessdata.fda.gov
Microscope, Operating & Accessories, Ac-Powered, OphthalmicHRM1Specification developeraccessdata.fda.gov
Microscope, SurgicalEPT1Specification developeraccessdata.fda.gov
Ophthalmic Femtosecond LaserOOE2Specification developeraccessdata.fda.gov
Photocoagulator And AccessoriesHQB2Specification developeraccessdata.fda.gov
Stand, Instrument, Ac-Powered, OphthalmicHMF1Specification developeraccessdata.fda.gov
Unit, PhacofragmentationHQC2Specification developeraccessdata.fda.gov
Vitrectomy, Instrument CutterMLZ2Specification developeraccessdata.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 7, 2026K252979Voyager DSLT (430840610)HQFSubstantially EquivalentBelkin Vision, Ltd.accessdata.fda.gov
September 24, 2025K252682LenSx Laser System (8065000944)OOESubstantially EquivalentAlcon Laboratories, Inc.accessdata.fda.gov
December 4, 2024K242184Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);MPASubstantially EquivalentAlcon Laboratories, Inc.accessdata.fda.gov
June 21, 2024K233876UNITY VCS (8065000296); UNITY CS (8065000297)HQCSubstantially EquivalentAlcon Laboratories, Inc.accessdata.fda.gov
January 10, 2024K233902Centurion™ Vision System (Active Sentry™) (8065753057)HQCSubstantially EquivalentAlcon Laboratories, Inc.accessdata.fda.gov
May 21, 2020K200400Systane iLux2ORZSubstantially EquivalentTear Film Innovations, Inc.accessdata.fda.gov
November 1, 2019K191650LEGION SystemHQCSubstantially EquivalentAlcon Research, LLCaccessdata.fda.gov
March 27, 2018K173660LenSx Laser SystemOOESubstantially EquivalentAlcon Laboratories, Inc.accessdata.fda.gov
March 22, 2017K170520HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+MLZSubstantially EquivalentAlcon Research, Ltd.accessdata.fda.gov
August 22, 2014K141065CONSTELLATION VISION SYSTEMHQESubstantially EquivalentAlcon Research, Ltd.accessdata.fda.gov
June 15, 2012K120912INFINITI(R) VISION SYSTEMHQCSubstantially EquivalentAlcon Manufacturing, Ltd.accessdata.fda.gov
November 21, 2011K112425INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECEHQCSubstantially EquivalentAlcon Manufacturing, Ltd.accessdata.fda.gov
October 17, 2011K11095127+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULAHQBSubstantially EquivalentAlcon Research, Ltd.accessdata.fda.gov
April 2, 2010K093305ENHANCED ULTRA VIT PROBEMLZSubstantially EquivalentAlcon Research, Ltd.accessdata.fda.gov
November 5, 2007K062624NEXT GENERATION LASERHQFSubstantially EquivalentAlcon Laboratoriesaccessdata.fda.gov
July 2, 2002K021566INFINITIHQCSubstantially EquivalentAlcon Laboratories, Inc.accessdata.fda.gov
April 22, 1991K910245I/A HANDPIECE WITH REPLACEABLE TIPSGBXSubstantially EquivalentSurgical Technologies, Inc.accessdata.fda.gov
March 24, 1989K890509INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEMHQFSubstantially EquivalentBiophysic Medical, Inc.accessdata.fda.gov

PMA approvals

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

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
July 29, 2016P150037CyPass Micro-StentOGO12April 9, 2020accessdata.fda.gov

Compare with other makers

Updated April 7, 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.