BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Sterilizer, Soft-Lens, Thermal, Ac-Powered

    PMA: P840054 · Supplement: S001 · Decision May 10, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Sterilizer, Soft-Lens, Thermal, Ac-Powered
    Trade Name
    MODEL NO. ALS-IV HEAT DISINFECTION UNIT
    PMA Number
    P840054
    Supplement Number
    S001
    Device Class
    FDA Class 2
    Product Code
    HRD
    Generic Name
    Sterilizer, soft-lens, thermal, ac-powered
    Regulation Number
    886.5928
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 10, 1988
    Date Received
    December 4, 1987
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Classifications

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

    Product Code Device Name
    HRD Sterilizer, Soft-Lens, Thermal, Ac-Powered