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Johnson & Johnson Surgical Vision, Inc.

USA · Irvine

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 10 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

23listed device types

Class I 5Class II 11Class III 7

plus 71 registration records and 24 510(k), 684 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

39registered devices

Class I 7Class II 32

79 including historic records

SASaudi ArabiaSFDA

2registered imported devices

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

CACanadaMDALL

19active device licences

Class II 5Class III 14

85 including historic records

TWTaiwanTFDA

8valid device licences

Class I 2Class II 2Class III 4

SGSingaporeHSA SMDR

54device registrations

CLASS B 9CLASS C 44CLASS D 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

31active ARTG entries

Class I 2Class III 10IIa 9IIb 10

HKHong KongMDACS

30valid listings

Class II 3Class III 26Class IV 1

ILIsraelAMAR

7registrations

RURussiaRoszdravnadzor

22active registrations

Class 2a 1Class 2b 21

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 States71 registration records, 24 510(k), 684 PMA, 61 excluded

Brazil39 confirmed, 8 excluded

Saudi Arabia2 confirmed, 5 excluded

Canada19 confirmed, 8 excluded

Manufacturer names merged into this page: JOHNSON & JOHNSON VISION CARE IRELAND UNLIMITED COMPANY · Johnson & Johnson Surgical Vision, Inc. · JOHNSON & JOHNSON VISION CARE, INC. · JOHNSON & JOHNSON SURGICAL VISION, INC. · JOHNSON & JOHNSON SURGICAL VISION, INC · JOHNSON & JOHNSON SURGICAL VISION, INC. (IRVINE)

FDA 510(k) clearances by year

11995

11996

11997

31999

22000

12001

22003

12005

12006

12008

12010

12014

12016

12018

22019

12020

22021

12023

FDA listed device types

showing 8 of 23

Intraocular Lens 1Aid, Surgical, Viscoelastic 1Lens, Intraocular, Toric Optics 1Excimer Laser System 1Extended Depth Of Focus Intraocular Lens 1Lens, Multifocal Intraocular 1Lenses, Soft Contact, Extended Wear 1Electrosurgical, Cutting & Coagulation & Accessories 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K223566	ELITA Femtosecond Laser System, ELITA Patient Interface	2023-04-14
US	K210930	ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A)	2021-11-29
US	K203060	VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control	2021-03-12
BR	80148620019	ACUVUE 2 (ETAFILCON A) LENTES DE CONTATO	Class II
BR	80145909122	Lentes de contato ACUVUE® OASYS MAX 1-Day Multifocal	Class II
BR	80145909123	Lentes de contato ACUVUE® OASYS MAX 1-Day	Class II
SA	ME0000003608SFDAA00001	UNFOLDER Vitan™ Inserter	—
SA	ME0000007152SFDAA00034	UNFOLDER Vitan™ Inserter	—
CA	2147	GENFILCON-A CONTACT LENSES	Class II
CA	15234	VISTAKON LENEFILCON-A CONTACT LENSES	Class II
CA	63133	VISTAKON (GALYFILCON A) CONTACT LENSES	Class II

Johnson & Johnson Surgical Vision, Inc.

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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