BEUDAMED
    Product Code: RDZ FDA not classified

    Low-Power Laser Light Show Projector

    Unknown

    The Low-Power Laser Light Show Projector (product code RDZ) is a laser projection system that incorporates a laser having a maximum radiation output of less than 5 mW, classified as Class IIIa/3R or lower, used for laser light show and display demonstrations. This product is FDA not classified and falls under electronic product radiation control authority rather than standard medical device classification. It is GMP exempt with no associated regulation number, medical specialty, implant flag, or life-sustaining designation.

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    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    RDZ
    Device Class
    FDA not classified
    Medical Specialty
    Unknown

    Device Characteristics

    ✓
    GMP Exempt
    —
    Implant
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    Life Sustain/Support
    —
    Third Party
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    Summary Malfunction Reporting

    Definition

    Product, laser, demo, projector, laser light show/display, class iiia/3r and lower; Laser projection system that incorporates a laser having a maximum radiation output of less than 5mw.