BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    LightSheer 1060 ET Handpiece

    Reg #: 3021349626 · FEI: 3021349626 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    13
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Lumenis Be Ltd
    Registration Number
    3021349626
    FEI Number
    3021349626
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    9 Hakidma St, POB # 426, Yokneam Industrial Park
    City
    Yokneam, Ha Zafon 2069236 Haifa
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K170179

    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

    US Agent

    Business Name
    Lumenis Be Inc
    Contact Name
    Michael Robinson
    Address
    1870 S Milestone Dr
    City
    Salt Lake City
    State
    UT
    ZIP
    84104
    Country
    US
    Email
    [email protected]
    Phone
    801 6562574

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    LightSheer 1060 ET Handpiece LightSheer DESIRE LightSheer Desire Light LightSheer 805 XC Handpiece LightSheer Duet Laser System LightSheer 805 ET Handpiece LightSheer QUATTRO LightSheer 1060 XC Handpiece LightSheer 1060 HS Handpiece High-Speed Disposables Kit LightSheer 805 HS Handpiece LightSheer Duet HS Handpiece LightSheer Duet ET Handpiece

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility