BEUDAMED
    FDA Registration Active 🇨🇳 China

    Fractional CO2 Laser Therapy System (EXFU CO2)

    Reg #: 3025430555 · FEI: 3025430555 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SHANDONG SMAYER ELECTRONICS CO.,LTD
    Registration Number
    3025430555
    FEI Number
    3025430555
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1-103, Building 15, Phase 1, Yuandu Huizhi Industrial Complex, No.3999
    City
    Weifang Shandong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K242183

    Owner / Operator

    Firm Name
    Shandong Smayer Electronics Co.,LTD
    Operator Number
    10086530
    Address
    1-103, Building 15, Phase 1, Yuandu Huizhi Industrial Complex, No.3999
    City
    Weifang
    State
    Shandong
    Postal Code
    261000
    Country
    CN
    Correspondent
    Ray Wang

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument With MicrobeamFractional Output ONG
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    Fractional CO2 Laser Therapy System (EXFU CO2)

    Establishment Types

    Manufacture Medical Device