BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Norlase INC

    Reg #: 3016405041 · FEI: 3016405041 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    2

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    Registration Details

    Registration Name
    Norlase INC
    Registration Number
    3016405041
    FEI Number
    3016405041
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    895 Hurlingame Ave
    City
    Redwood City
    State
    CA
    ZIP
    94063
    Country
    US

    Regulatory Submissions

    510(k) Number
    K190083

    Owner / Operator

    Firm Name
    Norlase ApS
    Operator Number
    10061124
    Address
    Brydehusvej 13
    City
    Ballerup
    State
    Hovedstaden
    Postal Code
    2750
    Country
    DK
    Correspondent
    Jan F Bitz

    Products

    Device Name Product Code
    Laser, Ophthalmic HQF
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    LEAF ECHO LYNX LION

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device