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510(k) Data Aggregation

    K Number
    K211901
    Device Name
    MolecuLightDX
    Manufacturer
    MolecuLight Inc.
    Date Cleared
    2021-07-21

    (30 days)

    Product Code
    QJF, FXN
    Regulation Number
    878.4550
    Why did this record match?
    Applicant Name (Manufacturer) :

    MolecuLight Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MolecuLightDX is a handheld imaging tool that allows clinicians diagnosing and treating skin wounds, at the point of care, to - (i) View and digitally record images of a wound, - (ii) Measure and digitally record the size of a wound, and - (iii) View and digitally record images of fluorescence emitted from a wound when exposed to an excitation light. The fluorescence image, when used in combination with clinical signs and symptoms, has been shown to increase the likelihood that clinicians can identify wounds containing bacterial loads >104 CFU per gram as compared to examination of clinical signs and symptoms alone. The MolecuLightDX device should not be used to rule-out the presence of bacteria in a wound. The MolecuLightDX does not diagnose or treat skin wounds.
    Device Description
    The MolecuLightDX Imaging Device is a handheld medical imaging device comprised of a high-resolution color AMOLED display and touch-sensitive screen with integrated optical and microelectronic components. MolecuLightDX uses its patented technology to enable real-time standard digital imaging and fluorescence imaging in wounds and surrounding healthy skin of patients as well as wound area measurements.
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    K Number
    K210882
    Device Name
    MolecuLight I:X
    Manufacturer
    MolecuLight Inc.
    Date Cleared
    2021-06-22

    (89 days)

    Product Code
    QJF, FXN
    Regulation Number
    878.4550
    Why did this record match?
    Applicant Name (Manufacturer) :

    MolecuLight Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MolecuLight i:X is a handheld imaging tool that allows clinicians diagnosing and treating skin wounds, at the point of care, to (i) View and digitally record images of a wound. (ii) Measure and digitally record the size of a wound, and (iii) View and digitally record images of fluorescence emitted from a wound when exposed to an excitation light. The fluorescence image, when used in combination with clinical signs and symptoms, has been shown to increase the likelihood that clinicians can identify wounds containing bacterial loads >104 CFU per grams as compared to examination of clinical signs and symptoms alone. The MolecuLight i:X device should not be used to rule-out the presence of bacteria in a wound. The MolecuLight i:X does not diagnose or treat skin wounds.
    Device Description
    The MolecuLight i:X Imaging Device is a handheld medical imaging device comprised of a high-resolution color LCD display and touch-sensitive screen with integrated optical and microelectronic components. MolecuLight i:X uses its patented technology to enable real-time standard digital imaging and fluorescence imaging in wounds and surrounding healthy skin of patients as well as wound area measurements.
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    K Number
    K191371
    Device Name
    MolecuLight i:X
    Manufacturer
    MolecuLight Inc.
    Date Cleared
    2019-12-04

    (196 days)

    Product Code
    QJF, FXN, OJF
    Regulation Number
    878.4550
    Why did this record match?
    Applicant Name (Manufacturer) :

    MolecuLight Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MolecuLight i:X is a handheld imaging tool that allows clinicians diagnosing and treating skin wounds, at the point of care, to - View and digitally record images of a wound, (i) - Measure and digitally record the size of a wound, and (ii) - View and digitally record images of fluorescence emitted from a wound when exposed to an excitation light. (iii) The fluorescence image, when used in combination with clinical signs and symptoms, has been shown to increase the likelihood that clinicians can identify wounds containing bacterial loads >104 CFU per gram as compared to examination of clinical signs and symptoms alone. The MolecuLight i:X device should not be used to rule-out the presence of bacteria in a wound. The MolecuLight i:X does not diagnose or treat skin wounds.
    Device Description
    The MolecuLight i:X Imaging Device is a handheld medical imaging device comprised of a high-resolution color LCD display and touch-sensitive screen with integrated optical and microelectronic components. Moleculight i:X uses its patented technology to enable real-time standard digital imaging and fluorescence imaging in wounds and surrounding healthy skin of patients as well as wound area measurements.
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    K Number
    DEN180008
    Device Name
    MolecuLight i:X
    Manufacturer
    MolecuLight Inc.
    Date Cleared
    2018-07-31

    (165 days)

    Product Code
    QCR
    Regulation Number
    878.4165
    Why did this record match?
    Applicant Name (Manufacturer) :

    MolecuLight Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MolecuLight i:X is a handheld imaging tool that allows clinicians diagnosing and treating skin wounds, at the point of care, to - view and digitally record images of a wound, and (i) - view and digitally record images of fluorescence emitted from a wound (ii) when exposed to an excitation light. The MolecuLight i:X is for prescription use only.
    Device Description
    The MolecuLight i:X is a handheld, portable, and battery operated white light and fluorescence imaging tool. The MolecuLight i:X can (i) view and digitally record standard (ST) digital images of a wound. Standard digital images/video capture the appearance of the wound under illumination of broad band white light, like regular photography. This Standard Imaging Mode does not require contact with the patient and the distance between the device and wound is kept consistent (8 - 12 cm) between imaging sessions through the use of the built in range finder The MolecuLight i:X can also capture fluorescence features of wounds in real-time when used in Fluorescence Imaging Mode and it enables the user to document this fluorescence information. When the level of ambient light in the examination room is acceptable, an indicator light informs the user that fluorescence images (or videos) can be acquired. The distance between the device to the patient is maintained at 8 - 12 cm as guided by the range finder indicator light. The device has 450nm excitation light and is capable to detect fluorescence signals in 500-545 and 600-665nm wavelengths. The Moleculight i:X is not intended to quantify the fluorescence emitted from a wound.
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