BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    SurgiTouch Scanner

    Reg #: 3021349626 · FEI: 3021349626 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    14
    Establishment Types
    2
    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
    K212703

    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

    SurgiTouch Scanner FemTouch SurgiTouch Scanning Handpiece 260mm SurgiTouch Scanning Handpiece 200mm SurgiTouch Scanning Handpiece 125mm FemX handpieces FemTouch Disposable Tips AcuPulse CO2 Laser System AcuPulse Incisional Handpiece 125 mm AcuScan 120 Microscanner AcuPulse Upgrade Kit 40 to 40AES-R AcuPulse Upgrade Kit 40 to 40AES-F AcuPulse Upgrade Kit 40AES-F to 40AES-R SurgiTouch Scanning Handpiece Set

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device