BEUDAMED
    Product Code: LMS FDA class 2 21 CFR 874.4490

    Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology

    Ear, Nose, Throat

    Laser, Microsurgical Argon, for Uses Other Than Otology, Including Laryngology and General Use in Otolaryngology is an argon laser system used in microsurgical procedures of the ear, nose, and throat, specifically for applications outside of the inner ear such as laryngeal surgery, treatment of vascular lesions, or other precision procedures in the head and neck region. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LMS, regulated under 21 CFR 874.4490, within the Ear, Nose, and Throat medical specialty. This device is eligible for third-party 510(k) review.

    View on FDA
    510(k)s
    2
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    2
    Years Active
    1

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    Basic Information

    Product Code
    LMS
    Device Class
    FDA class 2
    Regulation Number
    874.4490
    Medical Specialty
    Ear, Nose, Throat
    Review Panel
    EN
    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 2 510(k) clearances via K numbers.

    K Number Device Name
    K871424 ENDOCOAGULATOR MODEL 5, 8 & 20 ARGON LASER
    K855146 LASERSCOPE OMNIPLUS PHOTOSURGICAL SYST/ND:YAG OTOL