BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lenses, Soft Contact, Extended Wear

    PMA: P010019 · Supplement: S002 · Decision Mar 19, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56

    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    NIGHT & DAY 30 NIGHT EXTENDED WEAR SOFT CONTACT LENS
    PMA Number
    P010019
    Supplement Number
    S002
    Device Class
    FDA Class 3
    Product Code
    LPM
    Generic Name
    Lenses, soft contact, extended wear
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 19, 2003
    Date Received
    February 24, 2003
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING INDICATION: NIGHT & DAY SOFT CONTACT LENSES ARE ALSO INDICATED FOR THERAPEUTIC USE. USE AS A BANDAGE TO PROTECT THE CORNEA AND TO RELIEVE CORNEAL PAIN DURING THE TREATMENT OF ACUTE OR CHRONIC OCULAR PATHOLOGIES SUCH AS BULLOUS KERATOPATHY, CORNEAL EROSIONS, ENTROPION, CORNEAL EDEMA, AND CORNEAL DYSTROPHIES AS WELL AS POST-SURGICAL CONDITIONS RESULTING FROM CATARACT EXTRACTION AND CORNEAL SURGERY. NIGHT & DAY SOFT CONTACT LENSES FOR THERAPEUTIC USE CAN ALSO PROVIDE OPTICAL CORRECTION DURING HEALING IF REQUIRED.

    Classifications

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

    Product Code Device Name
    LPM Lenses, Soft Contact, Extended Wear