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510(k) Data Aggregation

    K Number
    K992286
    Device Name
    DERMAFREEZE
    Manufacturer
    RHEALM PHARMACEUTICALS, INC.
    Date Cleared
    2000-01-21

    (198 days)

    Product Code
    MLY
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    DermaFreeze™ is a vapocoolant intended for topical application for the control of pain associated with minor surgical procedures (such as lancing boils, or incision and drainage of small abscesses), injections, and contusions.

    Device Description

    DermaFreeze™ is a vapocoolant

    AI/ML Overview

    I'm sorry, but this document is a 510(k) clearance letter from the FDA for a device called "DermaFreeze™". It is a regulatory document confirming that the device is substantially equivalent to a predicate device already on the market.

    This type of document does not contain information about acceptance criteria or a study proving the device meets those criteria, as it relates to the performance of an AI/ML powered device.

    Therefore, I cannot extract the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methodology from this document.

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