BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    LASEROPTEK

    Reg #: 3007181527 · FEI: 3007181527 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    1

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    Registration Details

    Registration Name
    LASEROPTEK
    Registration Number
    3007181527
    FEI Number
    3007181527
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Hyundai I valley 114,116,117,203,204 and 215 31, Galmachi-ro, 244beon-gil, Jungwon-gu,
    City
    Seongnam Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K203491

    Owner / Operator

    Firm Name
    Laseroptek Co., Ltd.
    Operator Number
    10029810
    Address
    Hyundai I Valley 114,116,117,203,204,215, 31, Galmachi-ro 244beon-gil, Jungwon-gu
    City
    Seongnam-si
    State
    Gyeonggi
    Postal Code
    13212
    Country
    KR
    Correspondent
    HONG CHU

    US Agent

    Business Name
    BT Solutions USA, LLC
    Contact Name
    Do-Hyun Kim
    Address
    7816 Blue Ribbon Street
    City
    Fulton
    State
    MD
    ZIP
    20759
    Country
    US
    Email
    [email protected]
    Phone
    410 2949140

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    PicoLO Nd:YAG Picosecond Laser System PALLAS 308/311 Solid-State UV Laser System Lotus III Multi-Pulsed Er: YAG Laser System HYPERION Long Pulsed Nd:YAG Dermatological Laser HELIOS IV 785 HELIOS 785 Pico Helios III Q-Switched Nd:YAG Laser System PicoLO Premium PALLAS Premium

    Establishment Types

    Manufacture Medical Device