FDA.reportPublic FDA data

GIGAALASER COMPANY LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30171813583017181358GIGAALASER COMPANY LTD.1N2026-01-01B15-8F, Wuhan Hi-tech Medical Device Park, Gaoxin Road #818, Eas (Pilot Free Trade Zone Wuhan Area) Wuhan Hubei CN 430206

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
16977331780080GigaaMed - GBOX-15D7205894939BraunSolutions@live.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3067921324656688K250018Medical Diode Laser Systems (THEIA808)GEX2025-04-01
3067921583498230K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)ILY2025-05-19
3067921388579366K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D)GEX2025-03-19
3067921550307119K230047Medical Diode Laser SystemsNVK2024-03-04
3067921319650306K160549MEDICAL DIODE LASER SYSTEMSGEX2017-04-07
3067921318348478K142078VELASII THERAPY LASER SYSTEMILY2014-10-30
3067921308347508

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEX32025-04-01
ILY22025-05-19
NVK12024-03-04

GUDID#