DermaSensor is an AI-enabled medical device from DermaSensor Inc. that the U.S. FDA granted through De Novo DEN230008 on January 12, 2024. Its lead review panel is General and Plastic Surgery and its primary product code is QZS (Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer).
See also all FDA AI clearances in 2024.
Key facts
| Submission number | DEN230008 |
|---|---|
| Pathway | De Novo |
| Date of final decision | |
| Company (FDA list) | DermaSensor Inc. |
| Lead review panel | General and Plastic Surgery |
| Primary product code | QZS — Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer |
| Applicant (openFDA) | Dermasensor, Inc. |
| Applicant location | Miami, FL, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 878.1830 |
| Decision code | DENG |
| Submission type | Direct |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
De Novo is the pathway for novel low-to-moderate-risk devices with no predicate. A granted De Novo creates a new device classification that later devices can use as a predicate. DermaSensor went through this pathway (DEN230008).
openFDA lists it as a Class 2 device under 21 CFR 878.1830. Class II devices are moderate risk and are subject to general and special controls.
Product code QZS covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. DermaSensor Inc. has 1 AI-enabled device on the list, and the General and Plastic Surgery panel accounts for 9 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.