DERMASENSOR INC

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
1
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0583-2026Class IIDermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagOctober 13, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
DEN230008DermaSensorJanuary 12, 2024