Not Cleared Direct

DEN160029 - SkinPen Precision System (FDA 510(k) Clearance)

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

DEN160029 · Bellus Medical, LLC · General & Plastic Surgery device
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Mar 2018
Decision
604d
Days
Class 2
Risk

DEN160029 is an FDA 510(k) submission (not cleared) for the SkinPen Precision System. Classified as Powered Microneedle Device (product code QAI), Class II - Special Controls.

Submitted by Bellus Medical, LLC (Dallas, US). The FDA issued a Not Cleared (DENG) decision on March 1, 2018 after a review of 604 days.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4430 - 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 604 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.

View all Bellus Medical, LLC devices

Submission Details

510(k) Number DEN160029 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received July 05, 2016
Decision Date March 01, 2018
Days to Decision 604 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
490d slower than avg
Panel avg: 114d · This submission: 604d
Pathway characteristics

Device Classification

Product Code QAI Powered Microneedle Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4430
Definition A Powered Microneedle Device Is A Device Using One Or More Needles To Mechanically Puncture And Injure Skin Tissue For Aesthetic Use.
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.

Regulatory Peers - QAI Powered Microneedle Device

All 24
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