HomeUSASTAAR Surgical Company

STAAR Surgical Company

USA · Monrovia
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia — 7 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
6listed device types
Class I 2Class II 0Class III 4
plus 25 registration records and 25 510(k), 81 PMA
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class II 1
3 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
7active device licences
Class II 1Class III 3Class IV 3
11 including historic records
TWTaiwanTFDA
3valid device licences
Class I 1Class III 2
SGSingaporeHSA SMDR
8device registrations
CLASS B 1CLASS D 7
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
10active ARTG entries
Class III 7IIa 3
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 States25 registration records, 25 510(k), 81 PMA, 1 excluded
Brazil1 confirmed, 0 excluded
Canada7 confirmed, 0 excluded
Manufacturer names merged into this page: STAAR Surgical Company · STAAR SURGICAL AG · STAAR SURGICAL COMPANY

Company information

Country
USA
City
Monrovia

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Legal name
STAAR SURGICAL CO
CIK
0000718937
Registration status
Active
Listing status
Listed (STAA)

Business registration data from SEC EDGAR, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

21983
41985
51986
11988
11989
11991
11994
11995
21998
12002
12004
22008
12009
12015
12017

FDA listed device types

Folders And Injectors, Intraocular Lens (Iol) 1Lens, Guide, Intraocular 1Intraocular Lens 1Phakic Toric Intraocular Lens 1Lens, Intraocular, Toric Optics 1Lens, Intraocular, Phakic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK172375MicroSTAAR Injector System Cartridges2017-09-06
USK152357MicroSTAAR Injector System Cartridges2015-10-30
USK090161EPIPHANY INJECTION SYSTEM2009-06-09
BR81346509066Sistema de Injeção - MicroStaarClass II
CA6564PHACO KITClass II
CA26564AQUAFLOW COLLAGEN GLAUCOMA DRAINAGE DEVICEClass IV
CA1029ELASTIC LENS POSTERIOR CHAMBER INTRAOCULAR LENSClass III

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