BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    Stellar M22™

    Reg #: 3021349626 · FEI: 3021349626 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    15
    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
    DEN200028

    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
    Intense Pulsed Light Device For Managing Dry Eye QIU

    Proprietary Names

    Stellar M22™ Opti-Tip Pack OptiLight™ OptiLight IPL Module Kit OptiLight Aesthetic™ OPT Module Kit IPL Upgrade Kit for OptiLight OptiLight IPL Handpiece OPT Handpiece OptiLight Accessories Kit Digital OptiLight Aesthetic™ OptiLight IPL Modality Filters Kits Opti-Tip™ OptiLight AES General Accessories Kit OptiLight Filter

    Establishment Types

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