BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    RxSight Contact Lens

    K Number: K201909 · Decision Sep 10, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    40
    Applicant Total
    6
    Review Days
    63

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    Basic Information

    Device Name
    RxSight Contact Lens
    K Number
    K201909
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1385
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rxsight, Inc.
    Date Received
    July 9, 2020
    Decision Date
    September 10, 2020
    Product Code
    HJK
    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
    HJK Lens, Contact, Polymethylmethacrylate, Diagnostic

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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
    K192926 RxSight Insertion Device
    K181401 RxSight Insertion Device