DEN230008 is an FDA 510(k) submission for the DermaSensor. This device is classified as a Software-aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer (Class II - Special Controls, product code QZS).
Submitted by Dermasensor, Inc. (Miami, US). The FDA issued a Not Cleared (DENG) decision on January 12, 2024.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.1830. 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..
| 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 | - |
| Product Code | QZS - Software-aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer |
| Device Class | Class II - 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. |