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510(k) Data Aggregation

    K Number
    K971647
    Device Name
    LL BI-FOCAL, DAILY WEAR CONTACT LENS
    Manufacturer
    LOMBART LENSES, LTD.
    Date Cleared
    1997-07-15

    (71 days)

    Product Code
    LPL
    Regulation Number
    886.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    LOMBART LENSES, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LL Bi-Focal Soft (hydrophilic) Contact Lenses are indicated for daily wear by presbyopic patients with non-diseased eyes who are not aphakic and who have no more than 2.00 diopters of astigmatism and require powers from -6.00 to +6.00 and add powers of +1.50, +2.50 or +3.00.
    Device Description
    LL Bi-Focal , Soft (hydrophilic) Contact lens for Daily Wear
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    K Number
    K961428
    Device Name
    SOFT-55 DAILY WEAR CONTACT LENS
    Manufacturer
    LOMBART LENSES, LTD.
    Date Cleared
    1996-05-21

    (36 days)

    Product Code
    LPL
    Regulation Number
    886.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    LOMBART LENSES, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Soft-55 daily wear lenses have the same intended use as the predicate Softcon® DW lens; they are fit on the comea to correct the vision acuity of the patient. The lenses have identical indications, warnings, contra indications and produce the same effect on the eye.
    Device Description
    The Soft-55 daily wear contact lens design is substantially equivalent to the designs of the predicate lens currently in commercial distribution (Softcon® Daily Wear lens). The Soft-55 lens also has light transmission, refractive index and physical characteristics comparable to the predicate Softcon® Daily Wear lens.
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