Avinger, Inc. announced that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its new Lightbox 3 imaging console. Lightbox 3 incorporates advanced features, including an advanced solid-state laser for enhanced high-definition OCT imaging, a more powerful computing platform, and a redesigned software system with a highly intuitive user interface that emphasizes efficiency and ease-of-use. The Lightbox 3 presents a significant reduction in size, weight and cost compared to the existing platform, and is anticipated to accelerate the evaluation process and reduce barriers to developing new accounts.

The Lightbox 3 fits into a case the size of a carry-on suitcase and weighs less than 20 pounds. This 90% reduction in size and weight over the prior generation Lightbox console provides for easy transport, efficient installation options, and a simplified service strategy. The Company intends to initiate a limited launch of Lightbox 3 in the United States early in the first quarter of 2022 and subsequently expand to full commercial availability.