BEUDAMED
    FDA Registration Active 🇺🇸 United States

    LUMENIS BE INC.

    Reg #: 3020611964 · FEI: 1720381 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    13
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    LUMENIS BE INC.
    Registration Number
    3020611964
    FEI Number
    1720381
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1870 South Milestone Drive
    City
    Salt Lake City
    State
    UT
    ZIP
    84104
    Country
    US

    Regulatory Submissions

    510(k) Number
    K162837

    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
    Powered Laser Surgical Instrument GEX
    Laser, Ophthalmic HQF

    Proprietary Names

    Smart LIO Vision One LaserLink Z Selecta Duet Digital Trio Digital Duet Smart-V Illumination Add-on Kit Selecta Trio LaserLink S Kit Array LaserLink Eye Safety Filter Kit LaserLink HS Smart532

    Establishment Types

    Manufacture Medical Device