Not Cleared Direct

DEN180008 - MolecuLight i:X (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

DEN180008 · Moleculight, Inc. · General & Plastic Surgery device
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Jul 2018
Decision
165d
Days
Class 1
Risk

DEN180008 is an FDA 510(k) submission (not cleared) for the MolecuLight i:X. Classified as Wound Autofluorescence Imaging Device (product code QCR), Class I - General Controls.

Submitted by Moleculight, Inc. (Toronto, CA). The FDA issued a Not Cleared (DENG) decision on July 31, 2018 after a review of 165 days.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4165 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the General & Plastic Surgery review framework.

View all Moleculight, Inc. devices

Submission Details

510(k) Number DEN180008 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received February 16, 2018
Decision Date July 31, 2018
Days to Decision 165 days
Submission Type Direct
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 114d · This submission: 165d
Pathway characteristics

Device Classification

Product Code QCR Wound Autofluorescence Imaging Device
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4165
Definition A Wound Autofluorescence Imaging Device Is A Tool To View Autofluorescence Images From Skin Wounds That Are Exposed To An Excitation Light. The Device Is Not Intended To Provide Quantitative Or Diagnostic Information.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.