BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    PROCLEAR DAILY WEAR CONTACT LENS

    K Number: K952152 · Decision Jul 27, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    485
    Applicant Total
    3
    Review Days
    80

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    Basic Information

    Device Name
    PROCLEAR DAILY WEAR CONTACT LENS
    K Number
    K952152
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Biocompatibles , Ltd.
    Date Received
    May 8, 1995
    Decision Date
    July 27, 1995
    Product Code
    LPL
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LPL Lenses, Soft Contact, Daily Wear

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    Other Clearances by Biocompatibles , Ltd.

    K Number Device Name
    K961232 0.014 FLOPPY & 0.014 INTERMEDIATE GUIDE WIRES W/PHOSPHORYLCHOLINE POLYMER COATING & 4CM RADIOPAQUE TIP
    K955135 0.014 INTERMEDIATE GUIDE WIRE W/PHOSPHORYLCHOLINE POLYMER COATING