BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Selecta Duet

    Reg #: 3020611964 · FEI: 1720381 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    LUMENIS BE INC.
    Registration Number
    3020611964
    FEI Number
    1720381
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1870 South Milestone Drive
    City
    Salt Lake City
    State
    UT
    ZIP
    84104
    Country
    US

    Regulatory Submissions

    510(k) Number
    K220877

    Owner / Operator

    Firm Name
    Lumenis Be Ltd.
    Operator Number
    10082799
    Address
    9 Hakidma St, POB # 426, Yokneam Industrial Park
    City
    Yokneam Ha Zafon
    State
    Haifa
    Postal Code
    2069236
    Country
    IL
    Correspondent
    Shlomit Segman

    Products

    Device Name Product Code
    Laser, Ophthalmic HQF

    Proprietary Names

    Selecta Duet Digital Trio Smart-V Illumination Add-on Kit LaserLink S Kit Selecta Trio Digital Duet

    Establishment Types

    Manufacture Medical Device