Q Does the US FDA have to approve it first? Does it take a long time for the USFDA to approve a medical device like the Concerto?

Ans. Due to domestic market protection, the US FDA has been slow to approve of German lasers. For example, the earlier laser we used-The Wavelight Eye Q, was used by us for 4 years before being launched in the US. Now this is a popular laser in the USA. Wavelight platform is US FDA approved. The Concerto is the 3rd generation laser which is a concept laser and hence very few have been made. It has the European CE approval.

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