K213840 is an FDA 510(k) clearance for the MolecuLight I:X. Classified as Autofluorescence Imaging Adjunct Tool For Wounds (product code QJF), Class II - Special Controls.
Submitted by Moleculight, Inc. (Toronto, CA). The FDA issued a Cleared decision on May 18, 2022 after a review of 160 days - an extended review cycle.
This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4550 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.
View all Moleculight, Inc. devices
NCT03540004
Unknown
Observational
Industry-sponsored
Evaluation of MolecuLight i:X as an Adjunctive Fluorescence Imaging Tool to Clinical Signs and Symptoms for the Identification of Bacteria-containing Wounds
A Prospective, Single-blind, Multi-center Clinical Study Evaluating the Use of MolecuLight i:X as an Adjunctive Fluorescence Imaging Tool to Clinical Signs and Symptoms for the Identification of Bacteria-containing Wounds.
| Condition studied |
Wound |
| Eligibility |
All sexes
· 18 Years+
|
| Principal investigator |
Tomas E Serena, MD |
| Sponsor |
MolecuLight Inc.
(industry)
|
Started 2018-05-23
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Primary completion 2019-04-09
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Completed 2020-12-30
Primary outcome
Diagnostic accuracy of identifying wounds with moderate/heavy bacterial load as measured by sensitivity and specificity.
Secondary outcome
Estimation of sensitivity and specificity of MolecuLight i:X alone
View full study on ClinicalTrials.gov