Alex W.'s Blog

The FDA approved Luminopia One

On Wednesday morning I got a call from Scott Xiao, Luminopia’s current CEO, letting me know that we’d finally done it: Luminopia had an approved medical device.

Letter with the FDA insignia, stating “As a result of this order, you may immediately market your device as described in the De Novo request, subject to the general control provisions of the FD&C Act and the special controls identified in this order.”

5 years ago when we had our first face-to-face with the FDA, Scott had forgotten his Canadian passport so he wasn’t even allowed into the building.

Congrats Scott and Dean! What a journey 😊