Here is a more detailed discussion of the FDA approval and comparison to Cellvizio. Probably the most important words are "You may, therefore, market the device, subject to the general controls provisions of the Act."
https://www.accessdata.fda.gov/cdrh_docs/pdf18/K181116.pdf
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- Ann: ZEISS achieves another milestone on regulatory pathway
Ann: ZEISS achieves another milestone on regulatory pathway, page-42
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