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Gigaalaser Company Ltd

China · Wuhan Hubei · www.gigaamedical.com

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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

0UDI-DI device records

USUnited StatesFDA openFDA

5listed device types

Class I 1Class II 4Class III 0

plus 7 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

0registered device records

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

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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 States7 registration records, 4 510(k), 0 PMA

Manufacturer names merged into this page: GIGAALASER COMPANY LTD.

FDA 510(k) clearances by year

12024 · K230047

32025 · K242755

FDA listed device types

Lamp, Infrared, Therapeutic Heating 1Powered Laser Surgical Instrument 1Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis 1Laser, Dental, Soft Tissue 1Heat Source For Bleaching Teeth 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K242755	Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)	2025-05-19
US	K250018	Medical Diode Laser Systems (THEIA808)	2025-04-01
US	K241791	Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D)	2025-03-19

Gigaalaser Company Ltd

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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