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

    SAUFLON MULTIPURPOSE SOLUTION

    K Number: K130734 · Decision May 15, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    119
    Applicant Total
    12
    Review Days
    58

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    Basic Information

    Device Name
    SAUFLON MULTIPURPOSE SOLUTION
    K Number
    K130734
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5928
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sauflon Pharmaceuticals, Ltd.
    Date Received
    March 18, 2013
    Decision Date
    May 15, 2013
    Product Code
    LPN
    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
    LPN Accessories, Soft Lens Products

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    Other Clearances by Sauflon Pharmaceuticals, Ltd.

    K Number Device Name
    K133740 SAUFLON CLARITI WITH TINT, SAUFLON CLARITI TORIC WITH TINT, SAUFLON CLARITI MULTIFOCAL WITH TINT
    K130342 SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER
    K130331 SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER
    K052832 SAUFLON NEW DAY (METHAFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENSES
    K052809 SAUFLON FLAT COLOURED LENS CASE
    K033656 SAUFLON FLAT LENS CASE/SAUFLON 2003 BARREL LENS CASE
    K030278 SAUFLON MULTIPURPOSE SOLUTION - NO RUB
    K013649 SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS
    K010559 SAUFLON MULTI LENS CARE SYSTEM
    K011456 DELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONTACT LENSES
    Search all 12 clearances from Sauflon Pharmaceuticals, Ltd. →