BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    HULASER, INC.

    Reg #: 3010822033 · FEI: 3010822033 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HULASER, INC.
    Registration Number
    3010822033
    FEI Number
    3010822033
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1110, DAERUNG TECHNOTOWN 17, 25, GASAN DIGITAL 1-RO
    City
    GEUMCHEON-GU Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K200693

    Owner / Operator

    Firm Name
    HULASER, Inc.
    Operator Number
    10079483
    Address
    1110, DAERUNG TECHNOTOWN 17, 25, GASAN DIGITAL 1-RO
    City
    GEUMCHEON-GU
    State
    Seoul
    Postal Code
    08594
    Country
    KR
    Correspondent
    INBAE PARK

    US Agent

    Business Name
    KMC USA, Inc
    Contact Name
    Jung Ryun Ahn
    Address
    115 East 34th street, 13J
    City
    New York
    State
    NY
    ZIP
    10016
    Country
    US
    Email
    [email protected]
    Phone
    646 3576058

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    K2 MOBILE

    Establishment Types

    Manufacture Medical Device