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

Alcon Research, LLC: FDA-registered device maker in Irvine, CA, United States, 15 510(k) clearances and 2 PMA approvals

Name: Alcon Research, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Alcon Research, LLC is registered with the FDA (registration 2028159) in Irvine, CA, United States. It lists 20 device types. The FDA files 15 510(k) clearances and 2 PMA approvals under its listings, the newest dated April 7, 2026. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 2028159
FEI number: 1000125771
Address: 15800 Alton Pkwy, Irvine, CA, United States, 92618
Owner or operator: Alcon Laboratories, Inc. (1610287)
Roles: Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed: December 30, 1977
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Aberrometer, Ophthalmic	NCF	1	Manufacturer	accessdata.fda.gov
Apparatus, Cautery, Radiofrequency, Ac-Powered	HQR	2	Manufacturer	accessdata.fda.gov
Camera, Cine, Microsurgical, Without Audio	FWJ	1	Manufacturer	accessdata.fda.gov
Cannula, Ophthalmic	HMX	1	Manufacturer	accessdata.fda.gov
Cannula, Trocar, Ophthalmic	NGY	1	Manufacturer	accessdata.fda.gov
Drape, Surgical, Exempt	PUI	2	Manufacturer	accessdata.fda.gov
Eyelid Thermal Pulsation System	ORZ	2	Manufacturer	accessdata.fda.gov
Gases Used Within Eye To Place Pressure On Detached Retina	LPO	3	Manufacturer	accessdata.fda.gov
Instrument, Vitreous Aspiration And Cutting, Ac-Powered	HQE	2	Manufacturer	accessdata.fda.gov
Keratome, Ac-Powered	HNO	1	Manufacturer	accessdata.fda.gov
Laser, Ophthalmic	HQF	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Lens, Guide, Intraocular	KYB	1	Manufacturer	accessdata.fda.gov
Microscope, Operating & Accessories, Ac-Powered, Ophthalmic	HRM	1	Manufacturer	accessdata.fda.gov
Microscope, Surgical	EPT	1	Manufacturer	accessdata.fda.gov
Ophthalmic Femtosecond Laser	OOE	2	Manufacturer	accessdata.fda.gov
Photocoagulator And Accessories	HQB	2	Manufacturer	accessdata.fda.gov
Specula, Ophthalmic	HNC	1	Repackager or relabeler	accessdata.fda.gov
Stand, Instrument, Ac-Powered, Ophthalmic	HMF	1	Manufacturer	accessdata.fda.gov
Unit, Phacofragmentation	HQC	2	Manufacturer	accessdata.fda.gov
Vitrectomy, Instrument Cutter	MLZ	2	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
April 7, 2026	K252979	Voyager DSLT (430840610)	HQF	Substantially Equivalent	Belkin Vision, Ltd.	accessdata.fda.gov
September 24, 2025	K252682	LenSx Laser System (8065000944)	OOE	Substantially Equivalent	Alcon Laboratories, Inc.	accessdata.fda.gov
June 21, 2024	K233876	UNITY VCS (8065000296); UNITY CS (8065000297)	HQC	Substantially Equivalent	Alcon Laboratories, Inc.	accessdata.fda.gov
January 10, 2024	K233902	Centurion Vision System (Active Sentry) (8065753057)	HQC	Substantially Equivalent	Alcon Laboratories, Inc.	accessdata.fda.gov
May 21, 2020	K200400	Systane iLux2	ORZ	Substantially Equivalent	Tear Film Innovations, Inc.	accessdata.fda.gov
November 1, 2019	K191650	LEGION System	HQC	Substantially Equivalent	Alcon Research, LLC	accessdata.fda.gov
March 27, 2018	K173660	LenSx Laser System	OOE	Substantially Equivalent	Alcon Laboratories, Inc.	accessdata.fda.gov
December 26, 2017	K172645	iLux Instrument, iLux Disposable	ORZ	Substantially Equivalent	Tear Film Innovations, Inc.	accessdata.fda.gov
August 22, 2014	K141065	CONSTELLATION VISION SYSTEM	HQE	Substantially Equivalent	Alcon Research, Ltd.	accessdata.fda.gov
June 15, 2012	K120912	INFINITI(R) VISION SYSTEM	HQC	Substantially Equivalent	Alcon Manufacturing, Ltd.	accessdata.fda.gov
November 21, 2011	K112425	INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE	HQC	Substantially Equivalent	Alcon Manufacturing, Ltd.	accessdata.fda.gov
October 17, 2011	K110951	27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA	HQB	Substantially Equivalent	Alcon Research, Ltd.	accessdata.fda.gov
November 5, 2007	K062624	NEXT GENERATION LASER	HQF	Substantially Equivalent	Alcon Laboratories	accessdata.fda.gov
July 2, 2002	K021566	INFINITI	HQC	Substantially Equivalent	Alcon Laboratories, Inc.	accessdata.fda.gov
March 24, 1989	K890509	INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEM	HQF	Substantially Equivalent	Biophysic Medical, Inc.	accessdata.fda.gov

PMA approvals

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

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
August 26, 2024	P230012	UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy	LPO	11	September 30, 2026	accessdata.fda.gov
July 2, 2024	P220030	UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery	LPO	11	September 30, 2026	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
August 18, 2023	93010	Class II	Ongoing	Constellation Vision System, REF: 8065751150	Ophthalmic microsurgical vision systems have a new Printed Circuit Board (PCB) design that could lead to higher voltage to a PCB component, that could cause component failure and loss of pressure control for the use of cutters, scissors, and forceps, which could lead to an increased risk of microbial infection, tissue damage and progressive visual impairment	accessdata.fda.gov
April 30, 2010	55648	Not yet classified	Terminated	Constellation Vision System, Model: Constellation Vision System w/Laser, Catalogue Number: 8065751145 The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e	Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and fluidics issues.	accessdata.fda.gov
September 26, 2008	49600	Not yet classified	Terminated	PurePoint System Operator's Manual, Catalog Number 8065751131, Rev. B for use with the Alcon PurePoint Laser, Catalog Number 8065750597 Indicated for use in photocoagulation of both anterior and posterior segments of the	Alcon had identified that indications for use unapproved by the Food and Drug Administration are included in the PurePoint Laser System Operator's Manual, Catalog Number 8065751131, Revision B.	accessdata.fda.gov

Compare with other makers

Updated September 30, 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.