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510(k) Data Aggregation

    K Number
    K242669
    Device Name
    SnapshotGLO (KB100)
    Manufacturer
    Kent Imaging Inc.
    Date Cleared
    2025-03-26

    (202 days)

    Product Code
    QJF, FXN
    Regulation Number
    878.4550
    Why did this record match?
    Product Code :

    QJF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SnapshotGLO 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 SnapshotGLO device should not be used to rule-out the presence of bacteria in a wound. The SnapshotGLO does not diagnose or treat skin wounds.
    Device Description
    SnapshotGLO is a medical device that operates like a camera. It is a point-of-care, wound imaging device. This device is a non-contact imaging device wherein the wound images are captured from a height of ~12 cm using 395 nm LEDs and a white LED to produce a resultant fluorescence image that aids in visualising the bacteria on the wound and a colour-based "RGB" image or clinical image. Resultant images are viewed on the 7-inch touchscreen display. SnapshotGLO is based on autofluorescence imaging technology and uses native fluorescence of bacteria to determine the presence of bacterial bioburden and displays a two-dimensional, colour-coded highlight of bioburden presence on the wounds. SnapshotGLO is a handheld imaging tool that allows clinicians diagnosing, monitoring and treating skin wounds at the point of care with the help of the following features: . View and digitally record images of a wound, . Measure and digitally record the size of a wound, and View and digitally record images of fluorescence emitted from a wound when exposed to an ● excitation light SnapshotGLO consists of: - SnapshotGLO device - Medical grade adapter - User Manual - Quick Start Guide ● SnapshotGLO is intended for wound care applications as an adjunct tool that uses autofluorescence to detect tissues or structures. 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 high bacteria bioburden compared to clinical symptoms alone. SnapshotGLO should not be used to rule-out the presence of bacteria in a wound. This device is not intended to provide a diagnosis.
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    K Number
    K230734
    Device Name
    Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009)
    Manufacturer
    Precision Healing LLC
    Date Cleared
    2023-12-05

    (264 days)

    Product Code
    QJF, FXN, OCR
    Regulation Number
    878.4550
    Why did this record match?
    Product Code :

    QJF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MSI is a handheld imaging tool that allows clinicians diagnosing and treating skin wounds to: · View and digitally record images of a wound. · Measure and digitally record the size of a wound. - · View and digitally record images of fluorescence emitted from a wound when exposed to an excitation light. · View and digitally record thermal images of a wound. The MSI does not diagnose or treat skin wounds.
    Device Description
    The MSI Kit includes the following: the MSI, a Universal Serial Bus (USB-C) cable, a wall adapter, and a carrying case. The MSI captures and processes optical data of an imaged wound. The MSI consists of three imaging modalities: white light, autofluorescence and thermal. The MSI has 395nm excitation LEDs for autofluorescence imaging, a sensor for measuring distance to the wound, and a thermal sensor for capturing temperature gradients. The MSI is powered by an onboard rechargeable battery and has a USB-C connection for uploading images to a computer. The manual provides users of the MSI with detailed instructions for proper use, maintenance, and storage.
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    K Number
    K213840
    Device Name
    MolecuLight I:X
    Manufacturer
    MolecuLight, Inc.
    Date Cleared
    2022-05-18

    (160 days)

    Product Code
    QJF, FXN, QDG
    Regulation Number
    878.4550
    Why did this record match?
    Product Code :

    QJF

    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 >10^4 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 (FL) imaging in wounds and surrounding healthy skin of patients as well as wound area measurements.
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    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?
    Product Code :

    QJF

    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?
    Product Code :

    QJF

    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?
    Product Code :

    QJF

    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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