Cleared Traditional

MolecuLight i:X (K191371) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence.

K191371 · Moleculight, Inc. · General & Plastic Surgery device
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Dec 2019
Decision
196d
Days
Class 2
Risk

K191371 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 December 4, 2019 after a review of 196 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

Submission Details

510(k) Number K191371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2019
Decision Date December 04, 2019
Days to Decision 196 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 115d · This submission: 196d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QJF Autofluorescence Imaging Adjunct Tool For Wounds
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4550
Definition An Autofluorescence Detection Device For General Surgery And Dermatological Use Is An Adjunct Tool That Uses Autofluorescence To Detect Tissues Or Structures. This Device Is Not Intended To Provide A Diagnosis.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Ironstone Product Development
Joel Ironstone

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
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.

367
Patients (actual)
14
Sites
Condition studied Wound
Eligibility All sexes · 18 Years+
Principal investigator Tomas E Serena, MD
Sponsor MolecuLight Inc. (industry)
Started 2018-05-23 → Primary completion 2019-04-09 → 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