BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Gases Used Within Eye To Place Pressure On Detached Retina

    PMA: P230012 · Supplement: S008 · Decision Feb 10, 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 SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System
    PMA Number
    P230012
    Supplement Number
    S008
    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
    Approved
    Decision Code
    APPR
    Decision Date
    February 10, 2026
    Date Received
    August 28, 2025
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    increase of the dimension of the O-ring component used to create a seal between the plunger body and syringe barrel

    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