BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Accessories, Soft Lens Products

    PMA: P910074 · Supplement: S001 · 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
    CONTACLAIR MULTI-PURPOSE SOLUTION
    PMA Number
    P910074
    Supplement Number
    S001
    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
    April 18, 1997
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR EXPANDING THE INDICATIONS TO INCLUDE USE WITH SILICONE/ACRYLATE AND FLUOROSILICONE/ACRYLATE RIGID GAS PERMEABLE (RGP) CONTACT LENSES. WHEN USED WITH RGP LENSES, THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME, CONTACLAIR(R) RGP MULTI-PURPOSE SOLUTION, AND IS INDICATED FOR USE IN CLEANING, RINSING, DISINFECTING AND STORING DAILY AND EXTENDED WEAR RGP CONTACT LENSES.

    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