BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    Stellar M22™ IPL LightGuides

    Reg #: 3021349626 · FEI: 3021349626 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    28
    Establishment Types
    2
    Classifications
    3

    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
    K193500

    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
    Powered Laser Surgical Instrument With MicrobeamFractional Output ONG
    Powered Light Based Non-Laser Surgical Instrument With Thermal Effect ONF

    Proprietary Names

    Stellar M22™ IPL LightGuides Stellar M22™ accessory kit OptiLight IPL Upgrade Kit Stellar M22™ IPL filters Stellar M22™ IPL handpiece M22™ Nd:YAG Head Stellar M22™ Q-switched Nd:YAG upgrade kit Stellar M22™ calibration filter Nd:YAG LightGuides OptiLight IPL Handpiece OptiLight™ Stellar M22™ Acne filter Steller M22™ WIZ LMX System Stellar M22™ ResurFX™ Module Upgrade Kit Stellar M22™ M22™ Q-Switched Head Steller M22™ vascular filter Digital OptiLight Aesthetic™ OptiLight Aesthetics Digital OptiLight™ ResurFX™ Tips Stellar M22™ RFX system Stellar M22™ Multi-Spot™ Nd:YAG Upgrade kit Stellar M22™ AES IPL Module Kit ResurFX™ Head M22™ Q-Switched Lens & Metal Treatment Tip Kit M22™ Q-Switched Lens M22™ Q-Switched Nd:YAG Tips

    Establishment Types

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