Not Cleared Direct

DEN230008 - DermaSensor (FDA 510(k) Clearance)

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

DEN230008 · Dermasensor, Inc. · General & Plastic Surgery device
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Jan 2024
Decision
344d
Days
Class 2
Risk

DEN230008 is an FDA 510(k) submission (not cleared) for the DermaSensor. Classified as Software-aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer (product code QZS), Class II - Special Controls.

Submitted by Dermasensor, Inc. (Miami, US). The FDA issued a Not Cleared (DENG) decision on January 12, 2024 after a review of 344 days.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.1830 - 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 344 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 Dermasensor, Inc. devices

Submission Details

510(k) Number DEN230008 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received February 02, 2023
Decision Date January 12, 2024
Days to Decision 344 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
230d slower than avg
Panel avg: 114d · This submission: 344d
Pathway characteristics

Device Classification

Product Code QZS Software-aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.1830
Definition A Software-aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer Is A Prescription Device That Uses A Software Algorithm To Analyze Optical Or Other Physical Properties Of A Skin Lesion And Returns A Classification Of The Skin Lesion. The Device Is Intended For Use By A Physician Not Trained In The Clinical Diagnosis And Management Of Skin Cancer As An Adjunctive Second-read Device Following Identification Of A Suspicious Skin Lesion. It Is Not For Use As A Standalone Diagnostic And Is Not For Use To Confirm A Clinical 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.