BEUDAMED
    Product Code: HLD FDA class 1 21 CFR 886.4070

    Engine, Trephine, Accessories, Gas-Powered

    Ophthalmic

    The Gas-Powered Trephine Engine and Accessories is a surgical instrument used in ophthalmic procedures, particularly corneal transplantation (keratoplasty), to cut precise circular sections of corneal tissue using a gas-driven rotating trephine blade. It is classified as FDA Class 1, the lowest risk level, subject only to general controls without a premarket notification requirement. The product code is HLD, regulated under 21 CFR 886.4070, within the Ophthalmic medical specialty. No special risk flags apply to this device.

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    510(k)s
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    FEI Numbers
    0
    Registration Numbers
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    Unique Applicants
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    Years Active
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    Basic Information

    Product Code
    HLD
    Device Class
    FDA class 1
    Regulation Number
    886.4070
    Medical Specialty
    Ophthalmic
    Review Panel
    OP
    Submission Type
    4

    Device Characteristics

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