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510(k) Data Aggregation

    K Number
    K243701
    Device Name
    AuroLase® System
    Manufacturer
    Nanospectra Biosciences, Inc.
    Date Cleared
    2025-07-02

    (215 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Nanospectra Biosciences, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K202953
    Device Name
    Aurolase Therapy, Laser Delivery Device (LDD)
    Manufacturer
    Nanospectra Biosciences, Inc.
    Date Cleared
    2022-10-03

    (733 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Nanospectra Biosciences, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aurolase Therapy, Laser Delivery Device is a fiber-optical laser delivery device to be used with a compatible 810nm laser device for laser-based applications and procedures that are cleared for the compatible laser.
    Device Description
    Laser light generated by the Laser Module is delivery Device (LDD) Assembly, that is comprised of three components: the Laser Catheter Assembly (LCA), the Optical Fiber Diffuser (OFD), and the Coolant Supply Set (CSS). The LCA and OFD transmit laser energy to the tissue situated at their distal regions, to achieve the desired effect of the intended use. The use of coolant provides cooling for the surfaces of the CSS in contact with both the tissue and the LCA.
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