HomeKorea, RepublicLaseroptek Co., Ltd.

Laseroptek Co., Ltd.

Korea, Republic · Seongnam-Si
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, 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
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
1listed device types
Class I 0Class II 1Class III 0
plus 10 registration records and 13 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
6 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
1 including historic records
TWTaiwanTFDA
8valid device licences
Class II 8
SGSingaporeHSA SMDR
3device registrations
CLASS C 3
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
5active ARTG entries
IIb 5
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
4active registrations
Class 2b 4
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 States10 registration records, 13 510(k), 0 PMA
Manufacturer names merged into this page: LASEROPTEK · LASEROPTEK CO., LTD. · Laseroptek Co. Ltd.

Company information

Country
Korea, Republic
City
Seongnam-Si

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

22009
12016
12017
12018
12019
12020
22021
12022
22023
12025

FDA listed device types

Powered Laser Surgical Instrument 1

Registration details (sample)

MarketIdentifierNameClass / date
USK243780HELIOS 785 Pico (1754V2)2025-02-07
USK230373HELIOS 785 Pico2023-05-22
USK223588PALLAS Premium2023-01-26

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