HomeTaiwanLightmed Corporation

Lightmed Corporation

Taiwan · New Taipei City
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 8 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
pendingnot queried
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
3listed device types
Class I 1Class II 2Class III 0
plus 9 registration records and 10 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
3 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
2device registrations
CLASS C 2
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
2active ARTG entries
IIb 2
HKHong KongMDACS
3valid listings
Class III 3
ILIsraelAMAR
4registrations
RURussiaRoszdravnadzor
3active registrations
Class 2b 3
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 States9 registration records, 10 510(k), 0 PMA, 3 excluded
Manufacturer names merged into this page: LIGHTMED CORP. · LIGHTMED CORPORATION

Company information

Country
Taiwan
City
New Taipei 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

12001
12002
12007
32009
12011
12013
12015
12016

FDA listed device types

Powered Laser Surgical Instrument 1Laser, Ophthalmic 1Table, Instrument, Powered, Ophthalmic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK152688LightLas Multi-Wavelength Medical Laser System2016-06-15
USK142172LIGHTMED TRUSCAN 5772015-02-27
USK124043LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM2013-09-26

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