Data / Medical devices / Belgium / Alcon Laboratories Belgium

Alcon Laboratories Belgium: FDA-registered device maker in Puurs-Sint-Amands Antwerpen, Belgium, 4 510(k) clearances and 7 PMA approvals

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

Alcon Laboratories Belgium is registered with the FDA (registration 3015456951) in Puurs-Sint-Amands Antwerpen, Belgium. It lists 21 device types. The FDA files 4 510(k) clearances and 7 PMA approvals under its listings, the newest dated January 7, 2020. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3015456951
Address: Lichterveld 3, Puurs-Sint-Amands Antwerpen, Belgium, 2870
Owner or operator: Alcon Laboratories, Inc. (1610287)
Roles: Exporter to the US
First device listed: December 30, 1977
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Aid, Surgical, Viscoelastic	LZP	3	Exporter to the US	accessdata.fda.gov
Apparatus, Cautery, Radiofrequency, Ac-Powered	HQR	2	Exporter to the US	accessdata.fda.gov
Cannula, Ophthalmic	HMX	1	Exporter to the US	accessdata.fda.gov
Cannula, Trocar, Ophthalmic	NGY	1	Exporter to the US	accessdata.fda.gov
Clip, Iris Retractor	HOC	1	Exporter to the US	accessdata.fda.gov
Extended Depth Of Focus Intraocular Lens	POE	3	Exporter to the US	accessdata.fda.gov
Forceps, Ophthalmic	HNR	1	Exporter to the US	accessdata.fda.gov
Hook, Ophthalmic	HNQ	1	Exporter to the US	accessdata.fda.gov
Implant, Eye Valve	KYF	2	Exporter to the US	accessdata.fda.gov
Instrument, Vitreous Aspiration And Cutting, Ac-Powered	HQE	2	Exporter to the US	accessdata.fda.gov
Intraocular Lens	HQL	3	Exporter to the US	accessdata.fda.gov
Knife, Ophthalmic	HNN	1	Exporter to the US	accessdata.fda.gov
Lens, Fundus, Hruby, Diagnostic	HJI	1	Exporter to the US	accessdata.fda.gov
Lens, Intraocular, Toric Optics	MJP	3	Exporter to the US	accessdata.fda.gov
Lens, Multifocal Intraocular	MFK	3	Exporter to the US	accessdata.fda.gov
Photocoagulator And Accessories	HQB	2	Exporter to the US	accessdata.fda.gov
Ring, Endocapsular	MRJ	3	Exporter to the US	accessdata.fda.gov
Scissors, Ophthalmic	HNF	1	Exporter to the US	accessdata.fda.gov
Spatula, Ophthalmic	HND	1	Exporter to the US	accessdata.fda.gov
Unit, Phacofragmentation	HQC	2	Exporter to the US	accessdata.fda.gov
Vitrectomy, Instrument Cutter	MLZ	2	Exporter to the US	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
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 12, 2010	K101285	CONSTELLATION VISION SYSTEM	HQC	Substantially Equivalent	Alcon Manufacturing, Ltd.	accessdata.fda.gov
July 2, 2002	K021566	INFINITI	HQC	Substantially Equivalent	Alcon Laboratories, Inc.	accessdata.fda.gov
March 26, 2002	K012852	EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS	KYF	Substantially Equivalent	Optonol, Ltd.	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
January 7, 2020	P190018	Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens	HQL	49	August 17, 2026	accessdata.fda.gov
March 21, 2005	P040020	ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER IOL	MFK	118	July 6, 2026	accessdata.fda.gov
October 23, 2003	P010059	MORCHER CAPSULAR TENSION RING, TYPES 14, 14A AND 14C	MRJ	10	November 4, 2024	accessdata.fda.gov
February 24, 2000	P990023	CELLUGEL(R) OPHTHALMIC VISCOSURGICAL DEVICE	LZP	18	September 22, 2022	accessdata.fda.gov
December 22, 1994	P930014	ACRYSOF (R) UV ABSORBING INTRAOCULAR LENSES	HQL	161	July 8, 2026	accessdata.fda.gov
September 26, 1991	P890047	PROVISC(TM)VISCOELASTIC PREPARATION	LZP	68	October 1, 2026	accessdata.fda.gov
April 30, 1986	P840064	VISCOAT(TM)/DVOVISC/DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICES	LZP	90	October 1, 2026	accessdata.fda.gov

Compare with other makers

Updated August 17, 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.