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

    LightLas Pattern Scanning System - TruScan Pro

    K Number: K190448 · Decision May 24, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    61
    Same Product Code
    179
    Applicant Total
    2
    Review Days
    88

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    Basic Information

    Device Name
    LightLas Pattern Scanning System - TruScan Pro
    K Number
    K190448
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4390
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Light-Med(Usa), Inc.
    Date Received
    February 25, 2019
    Decision Date
    May 24, 2019
    Product Code
    HQF
    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
    HQF Laser, Ophthalmic

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    Other Clearances by Light-Med(Usa), Inc.

    K Number Device Name
    K990075 LPULSA SYL-9000 OPHTHALMIC YAG LASER