BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MolecuLight i:X System

    DI: 00628110259325 · Model: 1153-11 · MolecuLight Inc
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MolecuLight i:X System
    Primary DI
    00628110259325
    Version / Model
    1153-11
    Company Name
    MolecuLight Inc
    Labeler DUNS
    202822052
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-01-04
    Public Version
    1
    Public Version Date
    2022-01-12
    Public Version Status
    New
    Public Device Record Key
    748832fa-3512-42c0-a424-afc6d677b873

    Device Description

    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 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.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    QJF Autofluorescence Imaging Adjunct Tool For Wounds
    FXN Tape, Camera, Surgical

    GMDN Terms

    Code Name
    63176 Fluorescence wound imaging unit

    Identifiers

    Type ID
    Primary 00628110259325

    Premarket Submissions

    Submission Number Supplement Number
    K191371 000
    K210882 000