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Ithera Medical Gmbh
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Ithera Medical Gmbh and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-02-19FDA-DeviceClass IIThe MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile assembly of electrically-powered components intended for imaging and analysis of soft-tissue and vasculature using combined optoacoustic (photoacoustic) and ultrasound (US) imaging.
The MSOT Acuity Echo does not include an adequate instruction for safe operation of the device. The previous version of the user manuals contained a wrong value for the Nominal Ocular Hazard Distance (NOHD).
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