HomeUSANorlase INC

Norlase INC

USA · Redwood City
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, South Korea, Australia, Hong Kong — 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
2listed device types
Class I 0Class II 2Class III 0
plus 8 registration records and 4 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
1 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
4valid device licences
Class II 4
SGSingaporeHSA SMDR
3device registrations
CLASS C 3
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
4active ARTG entries
IIb 4
HKHong KongMDACS
4valid listings
Class III 4
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 States8 registration records, 4 510(k), 0 PMA
Manufacturer names merged into this page: Norlase INC · NORLASE APS

Company information

Country
USA
City
Redwood City

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.

FDA 510(k) clearances by year

12019 · K190083
12020 · K201623
12022 · K222157
12024 · K242397

FDA listed device types

Powered Laser Surgical Instrument 1Laser, Ophthalmic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK242397LYNX Photocoagulator2024-10-25
USK222157ECHO Photocoagulator2022-10-11
USK201623LION Photocoagulator2020-08-11

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