Ithera Medical Gmbh

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-1100-2025Class IIThe MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile assembly of elecJanuary 8, 2025