BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Gases Used Within Eye To Place Pressure On Detached Retina

    PMA: P220030 · Supplement: S011 · Decision May 28, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Gases Used Within Eye To Place Pressure On Detached Retina
    Trade Name
    UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System
    PMA Number
    P220030
    Supplement Number
    S011
    Device Class
    FDA Class 3
    Product Code
    LPO
    Generic Name
    Gases used within eye to place pressure on detached retina
    Regulation Number
    886.4270
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    May 28, 2026
    Date Received
    May 5, 2026
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    addition of a UNIFEYE nose piece bonding fixture used on the UNIFEYE check valve subassembly during the bonding and curing processes, changing from a manual to an automated torque test fixture to verify the bonding; and updating to the torque test method used during the UNIFEYE final assembly process for torque testing of the UNIFEYE check valve and mixture stop subassemblies.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LPO Gases Used Within Eye To Place Pressure On Detached Retina