DERMASENSOR INC
FDA Regulatory Profile
DERMASENSOR INC appears in FDA public data with 1 recall, 1 510(k) clearance, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0583-2026, Class II) was initiated on October 13, 2025. Its most recent 510(k) clearance was granted on January 12, 2024.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0583-2026 | Class II | DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diag | October 13, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| DEN230008 | DermaSensor | January 12, 2024 |