Well according to their web page - https://www.zeiss.com/meditec/int/products/neurosurgery/digital-biopsy-tool/convivo.html
1) ZEISS CONVIVO is a class 3R laser product in compliance with IEC60825-1. Not available for sale. 510(k) pending and may be subject to change.
Seems pretty clear.
Hopefully they will start selling them soon.
Well according to their web page -...
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