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

    Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers

    K Number: K220263 · Decision Nov 3, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    27
    Same Product Code
    29
    Applicant Total
    2
    Review Days
    276

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    Basic Information

    Device Name
    Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers
    K Number
    K220263
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4690
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vortex Surgical, Inc.
    Date Received
    January 31, 2022
    Decision Date
    November 3, 2022
    Product Code
    HQB
    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
    HQB Photocoagulator And Accessories

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    Other Clearances by Vortex Surgical, Inc.

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