BEUDAMED
    FDA Registration Active 🇨🇳 China

    GIGAALASER COMPANY LTD.

    Reg #: 3017181358 · FEI: 3017181358 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    10
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    GIGAALASER COMPANY LTD.
    Registration Number
    3017181358
    FEI Number
    3017181358
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    B15-8F, Wuhan Hi-Tech Medical device park, #818 Gaoxin Road, Wuhan 430206, China
    City
    Wuhan Hubei
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K230047

    Owner / Operator

    Firm Name
    Gigaalaser company ltd.
    Operator Number
    10085437
    Address
    B15-8F, Wuhan Hi-Tech Medical device park, #818 Gaoxin Road
    City
    Wuhan
    State
    Hubei
    Postal Code
    430206
    Country
    CN
    Correspondent
    Rui Jia

    US Agent

    Business Name
    dba BraunSolutions Regulatory Group
    Contact Name
    Alexander Braun Henderson
    Address
    2298 Americus Blvd E Apt 14
    City
    Clearwater
    State
    FL
    ZIP
    33763
    Country
    US
    Email
    [email protected]
    Phone
    720 5894939

    Products

    Device Name Product Code
    Heat Source For Bleaching Teeth EEG
    Lamp, Infrared, Therapeutic Heating ILY
    Powered Laser Surgical Instrument GEX
    Laser, Dental, Soft Tissue NVK
    Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis PDZ

    Proprietary Names

    Medical Diode Laser Systems Medical diode laser systems Medical diode laser systems THEIA Lipo Dua Medical diode laser systems VELASII-6H Medical diode laser systems VELAS Pro-30B15D Medical diode laser systems GBOX-6H Medical diode laser systems VELASII-15D Medical diode laser systems GBOX-10D, 12D, 15D VelasII Therapy Laser System

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)