BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    RxSight Insertion Device

    K Number: K181401 · Decision Jul 26, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    62
    Applicant Total
    6
    Review Days
    58

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    Basic Information

    Device Name
    RxSight Insertion Device
    K Number
    K181401
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4300
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rxsight, Inc.
    Date Received
    May 29, 2018
    Decision Date
    July 26, 2018
    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 Rxsight, Inc.

    K Number Device Name
    K261174 RxSight® Insertion Device
    K231838 RxSight® Insertion Device (63002)
    K231466 RxSight Insertion Device
    K201909 RxSight Contact Lens
    K192926 RxSight Insertion Device