BEUDAMED
    Product Code: HRC FDA class 2 21 CFR 886.5928

    Sterilizer, Soft-Lens, Thermal, Battery-Powered

    Ophthalmic

    A Battery-Powered Soft Lens Thermal Sterilizer is a portable ophthalmic device that uses heat generated by battery power to sterilize soft (hydrogel) contact lenses, inactivating microorganisms and ensuring the lenses are safe for wear. This device is FDA Class 2 (moderate risk), requiring premarket notification (510(k)) before marketing. It carries product code HRC 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
    —

    Basic Information

    Product Code
    HRC
    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

    Loading...

    Related 510(k) Clearances

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

    K Number Device Name
    K920037 OSTEO COMPRESSION HIP SCREW