BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PSLT with PASCAL Synthesis and PASCAL Synthesis TwinStar

    Reg #: 2939653 · FEI: 2939653 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Iridex Corporation
    Registration Number
    2939653
    FEI Number
    2939653
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1212 Terra Bella Avenue
    City
    MOUNTAIN VIEW
    State
    CA
    ZIP
    94043
    Country
    US

    Regulatory Submissions

    510(k) Number
    K180402

    Owner / Operator

    Firm Name
    Iridex Corporation
    Operator Number
    9001789
    Address
    1212 Terra Bella Avenue, --
    City
    Mountain View
    State
    CA
    Postal Code
    94043
    Country
    US

    Products

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

    Proprietary Names

    PSLT with PASCAL Synthesis and PASCAL Synthesis TwinStar

    Establishment Types

    Manufacture Medical Device