BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Optos Inc.

    Reg #: 3005744933 · FEI: 3005744933 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    13
    Establishment Types
    1
    Classifications
    3

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    Registration Details

    Registration Name
    Optos Inc.
    Registration Number
    3005744933
    FEI Number
    3005744933
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    155 Northboro Rd Ste 12
    City
    Southborough
    State
    MA
    ZIP
    01772
    Country
    US

    Regulatory Submissions

    510(k) Number
    K231673

    Owner / Operator

    Firm Name
    OPTOS PLC
    Operator Number
    9035556
    Address
    QUEENSFERRY HOUSE, CARNEGIE, BUSINESS CAMPUS
    City
    DUNFERMLINE, FIFE
    State
    GB-NOTA
    Postal Code
    KY11 8GR
    Country
    GB
    Correspondent
    Alan K Leitch

    Products

    Device Name Product Code
    Ophthalmoscope, Laser, Scanning MYC
    Tomography, Optical Coherence OBO
    Ophthalmoscope, Ac-Powered HLI

    Proprietary Names

    Monaco P200TE Panoramic P200T (Daytona) Daytona Panoramic 200T P200 200Dx PANORAMIC Optos SPECTRAL OCT/SLO 200Tx Panoramic 200MAAF Monaco Pro California

    Establishment Types

    Manufacture Medical Device