BEUDAMED
    Product Code: MUS FDA class 2 21 CFR 886.4670

    Fluidic, Phacoemulsification/Phacofragmentation

    Ophthalmic

    A Phacoemulsification/Phacofragmentation Fluidic System is a component of ophthalmic surgical systems used in cataract surgery to manage irrigation and aspiration fluid dynamics during ultrasonic emulsification and removal of the crystalline lens. It is FDA Class 2, requiring 510(k) clearance, with product code MUS under 21 CFR 886.4670 in the Ophthalmic specialty. The device is not an implant and is not life-sustaining.

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

    Basic Information

    Product Code
    MUS
    Device Class
    FDA class 2
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Review Panel
    OP
    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
    K980292 CATARACT LIQUEFRACTURE DEVICE