BEUDAMED
    Product Code: HRD FDA class 2 21 CFR 886.5928

    Sterilizer, Soft-Lens, Thermal, Ac-Powered

    Ophthalmic

    An AC-Powered Soft Lens Thermal Sterilizer is a mains-powered ophthalmic device that uses thermal energy to sterilize soft contact lenses by heat inactivation of microorganisms, providing a consistent and reliable method of lens disinfection for patients wearing hydrogel contact lenses. This device is FDA Class 2 (moderate risk), requiring premarket notification (510(k)) before marketing. It carries product code HRD and is regulated under 21 CFR 886.5928, within the Ophthalmic medical specialty. It is eligible for third-party review.

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

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    Basic Information

    Product Code
    HRD
    Device Class
    FDA class 2
    Regulation Number
    886.5928
    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
    K822828 SOFT LENS THERMAL DISINFECTING UNIT, A-C