Ithera Medical Gmbh

FDA Regulatory Profile

Ithera Medical Gmbh appears in FDA public data with 1 recall, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1100-2025, Class II) was initiated on January 8, 2025.

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