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Alcon Laboratories, Incorporated

USA · Fort Worth

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Singapore, Australia, Hong Kong, Israel, Russia — 9 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

21listed device types

Class I 9Class II 6Class III 6

plus 23 registration records and 91 510(k), 1,073 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

73registered devices

Class I 8Class II 65

131 including historic records

SASaudi ArabiaSFDA

16registered imported devices

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

CACanadaMDALL

53active device licences

Class II 25Class III 27Class IV 1

204 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

3device registrations

CLASS B 3

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

113active ARTG entries

Class I 14Class III 7IIa 48IIb 40Class Is (sterile) 4

HKHong KongMDACS

32valid listings

Class II 6Class III 24Class IV 2

ILIsraelAMAR

82registrations

RURussiaRoszdravnadzor

95active registrations

Class 1 4Class 2a 44Class 2b 38Class 3 9

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 States23 registration records, 91 510(k), 1,073 PMA, 12 excluded

Brazil73 confirmed, 4 excluded

Saudi Arabia16 confirmed, 1 excluded

Canada53 confirmed, 3 excluded

Manufacturer names merged into this page: Alcon Laboratories Belgium · ALCON LABORATORIES IRELAND LTD. · ALCON LABORATORIES INC. · ALCON LABORATORIES, INC. · ALCON LABORATORIES, INC · ALCON. LABORATORIES, INC

FDA 510(k) clearances by year

41997

101998

31999

22000

22002

22007

12012

12014

12015

72016

42017

62018

42019

22020

32021

12022

32023

32024

32025

12026

FDA listed device types

showing 8 of 21

Cannula, Trocar, Ophthalmic 1Knife, Ophthalmic 1Spatula, Ophthalmic 1Cannula, Ophthalmic 1Hook, Ophthalmic 1Forceps, Ophthalmic 1Clip, Iris Retractor 1Scissors, Ophthalmic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K254052	DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal	2026-02-13
US	K252682	LenSx Laser System (8065000944)	2025-09-24
US	K243896	LenSx Laser System (8065998162)	2025-04-28
BR	81869420150	SmartCataract DX	Class I
BR	81869429012	PRECISION 7 for Astigmatism	Class II
BR	81869420005	FMS Básico US	Class II
SA	ME0000004117SFDAA00022	Monarch Loading Forceps	—
SA	ME0000004117SFDAA00024	Sutherland Handle NG	—
CA	252	SERIES 20000 LEGACY PHACOEMULSIFIER	Class III
CA	254	UNIVERSAL PHACOEMULSIFIER	Class III
CA	291	OPHTHALAS 532 LASER	Class III

Alcon Laboratories, Incorporated

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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