BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇬🇧 United Kingdom

    RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector

    K Number: K143307 · Decision Dec 18, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    62
    Applicant Total
    4
    Review Days
    30

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    Basic Information

    Device Name
    RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector
    K Number
    K143307
    Device Class
    FDA class 1
    Clearance Type
    Special
    Regulation Number
    886.4300
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rayner Intraocular Lenses , Ltd.
    Date Received
    November 18, 2014
    Decision Date
    December 18, 2014
    Product Code
    MSS
    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
    MSS Folders And Injectors, Intraocular Lens (Iol)

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    Other Clearances by Rayner Intraocular Lenses , Ltd.

    K Number Device Name
    K141091 RAYSERT PLUS INJECTOR
    K132002 SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, RAYSERT SINGLE USE SOFT TIPPED SMALL INCISION DISPOSABLE INJECTOR
    K091507 RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18