The CZM disclaimer - "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".
A 510(k) requires demonstration of substantial equivalence to another legally U.S. marketed device. Substantial equivalence means that the new device is at least as safe and effective as the predicate.
A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA (Premarket Approval application)
The CZM would be 'substantially equivalent' to Mauna Kea's Cellvizio system that is FDA approved.
Check the fine print on the Mauna Kea brochure.
That takes care of the laser, but what about the sheath?
501(k) - Premarket Notification
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