BEUDAMED
    FDA Registration Active 🇨🇳 China

    Medical diode laser systems

    Reg #: 3017181358 · FEI: 3017181358 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GIGAALASER COMPANY LTD.
    Registration Number
    3017181358
    FEI Number
    3017181358
    Status
    Active
    Expiry Year
    2025
    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
    K160549

    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
    Regrek LLC
    Contact Name
    Leeyeo Kee
    Address
    19 Holly Cove Ln.
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US
    Email
    [email protected]
    Phone
    302 6089028

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    Medical diode laser systems

    Establishment Types

    Manufacture Medical Device