BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    RM Electrode (RMH 25-01)

    K Number: K253586 · Decision Apr 1, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    10
    Applicant Total
    2
    Review Days
    135

    Basic Information

    Device Name
    RM Electrode (RMH 25-01)
    K Number
    K253586
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1220
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Retmap, Inc.
    Date Received
    November 17, 2025
    Decision Date
    April 1, 2026
    Product Code
    HLZ
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HLZ Electrode, Corneal

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    Other Clearances by Retmap, Inc.

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