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510(k) Data Aggregation

    K Number
    K980607
    Device Name
    DERMATHERM 100
    Manufacturer
    NEW STAR LASERS, INC.
    Date Cleared
    1998-04-03

    (45 days)

    Product Code
    ILY
    Regulation Number
    890.5500
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K932881
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Dermatherm 100 is indicated for use to emit energy in the Infrared Spectrum to provide topical heating for the purpose of elevating and/or maintaining tissue temperature.

    Device Description

    See Attachment II

    AI/ML Overview

    The provided document does not contain information regarding acceptance criteria or a study that proves the device meets specific performance metrics. Instead, it is a 510(k) summary and FDA clearance letter for the Dermatherm 100, an infrared heat lamp.

    The key points from the document regarding performance and testing are:

    • Non-clinical Performance Data: None
    • Clinical Performance Data: None
    • Conclusion: The Dermatherm 100 is substantially equivalent to other existing Heat Lamps in commercial distribution (specifically, the Warm-Lamp by Olympic Medical, cleared under K932881).

    Therefore, based on the provided text, I cannot complete the requested tables and sections. The device's clearance was based on substantial equivalence to a predicate device, not on meeting specific acceptance criteria proven by a dedicated performance study as would be described for many AI/ML devices or novel technologies.

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