De Novo Classifications
FDA submissions for De Novo Classifications in the General, Plastic Surgery (SU) review panel, including product codes, regulations, and recent device decisions.
Section range: § 878.1830
CFR Part: 878
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| QZS | Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer | 878.1830 | 2 | 1 |
Recent Devices
| Record | Device | Applicant | Decision Date |
|---|---|---|---|
| DEN230008 | DermaSensor | Dermasensor, Inc. | Jan 12, 2024 |
