BEUDAMED
    Product Code: MXG FDA class 2 21 CFR 878.4630

    Lamp, Uvc, (For Treating Skin And Wounds)

    General, Plastic Surgery

    The UVC Lamp for Treating Skin and Wounds is a device that emits ultraviolet C light for therapeutic application to skin conditions and wound care. UVC light has germicidal properties and can be used to reduce bacterial burden on wounds and treat certain dermatological conditions. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 878.4630 (General and Plastic Surgery specialty). This device is eligible for third-party 510(k) review.

    View on FDA
    510(k)s
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    MXG
    Device Class
    FDA class 2
    Regulation Number
    878.4630
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K973865 BIRTCHER UV LAMP

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.