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510(k) Data Aggregation
K Number
K213840Device Name
MolecuLight I:X
Manufacturer
MolecuLight, Inc.
Date Cleared
2022-05-18
(160 days)
Product Code
QJF, FXN, QDG
Regulation Number
878.4550Why 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 >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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