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Alcon Research, Ltd.

USA · Lake Forest

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

58listed device types

Class I 24Class II 24Class III 10

plus 195 registration records and 18 510(k), 265 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

6 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

9active device licences

Class II 6Class III 3

17 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States195 registration records, 18 510(k), 265 PMA, 13 excluded

Brazil3 confirmed, 7 excluded

Saudi Arabia0 confirmed, 3 excluded

Canada9 confirmed, 4 excluded

Manufacturer names merged into this page: Alcon Research, LLC · CIBA VISION CORPORATION DOING BUSINESS ON BEHALF OF ALCON RESEARCH, LLC · ALCON RESEARCH LLC

FDA 510(k) clearances by year

12000

12001

12005

12006

22009

22010

32011

22012

22014

22017

12019

FDA listed device types

showing 8 of 58

Intraocular Lens 1Aid, Surgical, Viscoelastic 1Lens, Intraocular, Toric Optics 1Fluid, Intraocular 1Ring, Endocapsular 1Gases Used Within Eye To Place Pressure On Detached Retina 1Extended Depth Of Focus Intraocular Lens 1Lens, Multifocal Intraocular 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K191650	LEGION System	2019-11-01
US	K161794	CENTURION Vision System (Active SentryTM)	2017-04-14
US	K170520	HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+	2017-03-22
BR	81869420021	Instrumentos GRIESHABER REVOLUTION DSP	Class II
BR	81869420046	caneta para cirurgia oftalmologica	Class II
BR	81869420061	AIR OPTIX COLORS PLANA	Class II
CA	5067	VIFILCON A SOFT (HYDROPHILIC) DISPOSABLE CONTACT LENSES	Class II
CA	5074	CONTACT LENS - NELFILCON A	Class II
CA	35518	LOTRAFILCON B SOFT CONTACT LENSES	Class II

Alcon Research, Ltd.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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