BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Accessories, Soft Lens Products

    PMA: P860023 · Supplement: S012 · Decision Jul 3, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36

    Basic Information

    Device Name
    Accessories, Soft Lens Products
    Trade Name
    BAUSCH & LOMB(R) RENU(R) MULTI-PURPOSE SOLUTION
    PMA Number
    P860023
    Supplement Number
    S012
    Device Class
    FDA Class 2
    Product Code
    LPN
    Generic Name
    Accessories, soft lens products
    Regulation Number
    886.5928
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 3, 1997
    Date Received
    November 13, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE IN THE FORMULATION AND CORRESPONDING MODIFICATIONS TO THE LABELING. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BAUSCH & LOMB RENU MULTIPLUS(TM) MULTI-PURPOSE SOLUTION AND IS INDICATED FOR USE IN THE DAILY CLEANING, PROMOTION OF DAILY PROTEIN REMOVAL, RINSING, CHEMICAL (NOT HEAT) DISINFECTION AND STORAGE OF SOFT (HYDROPHILIC) CONTACT LENSES AS RECOMMENDED BY THE EYE CARE PRACTITIONER.

    Classifications

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

    Product Code Device Name
    LPN Accessories, Soft Lens Products