Not Cleared Post-NSE

DEN090012 - VIRULITE COLD SORE MACHINE (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN090012 · Virulite, LLC · General & Plastic Surgery device
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Oct 2012
Decision
1206d
Days
Class 2
Risk

DEN090012 is an FDA 510(k) submission (not cleared) for the VIRULITE COLD SORE MACHINE. Classified as Light Based Treatment For Cold Sores Herpes Simplex Virus-1 (product code OKJ), Class II - Special Controls.

Submitted by Virulite, LLC (Irvine, US). The FDA issued a Not Cleared (DENG) decision on October 18, 2012 after a review of 1206 days.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4860 - 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: Regulatory edge-case submission. High predicate equivalence gap. With 1206 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

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Submission Details

510(k) Number DEN090012 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received June 30, 2009
Decision Date October 18, 2012
Days to Decision 1206 days
Submission Type Post-NSE
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1092d slower than avg
Panel avg: 114d · This submission: 1206d
Pathway characteristics

Device Classification

Product Code OKJ Light Based Treatment For Cold Sores Herpes Simplex Virus-1
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4860
Definition Shortens Time To Healing Of Herpes Simplex Lesions On The Lips, With Time To Healing Defined As The Time To Patient Described Re-epithelialization.
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.