Cleared Traditional

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

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 114d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

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