Item 7.01 Regulation FD Disclosure.

On January 11, 2022, Avinger, Inc. (the "Company") issued a press release announcing receipt of 510(k) clearance from the U.S. Food & Drug Administration for the Company's Lightbox 3 imaging console. A copy of the press release is furnished as Exhibit 99.1 to this report.

The information furnished pursuant to this Item 7.01 and the exhibit hereto shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), and shall not be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.




Item 8.01 Other Events.

On January 11, 2022, the Company announced receipt of 510(k) clearance from the U.S. Food & Drug Administration for the Company's Lightbox 3 imaging console. Lightbox 3 incorporates a solid-state laser for enhanced high-definition OCT imaging, a more powerful computing platform, and a redesigned software system. The Lightbox 3 presents a significant reduction in size, weight, and cost compared to the existing platform. The Company intends to initiate a limited launch of Lightbox 3 in the first quarter of 2022 and subsequently expand to full commercial availability.

This Current Report on Form 8-K contains forward-looking statements that are made pursuant to the safe harbor provisions within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such forward-looking statements include, but are not limited to, statements related to the potential benefits of Lightbox 3 for patients and healthcare providers and the timing and scope of the commercial launch of Lightbox 3. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties, many of which are beyond our control, that may cause actual results or events to differ materially from those projected. These risks and uncertainties, many of which are beyond our control, include risks described in the section entitled "Risk Factors" and elsewhere in our Annual Report on Form 10-K filed with the SEC on March 11, 2021 and in our other filings with the SEC, including, without limitation, our reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at www.sec.gov. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

Item 9.01 Financial Statements and Exhibits.





Exhibit No.   Description
   99.1         Press Release of Avinger, Inc.
              issued on January 11, 2022.
    104       Cover Page Interactive Data File
              (embedded within the Inline XBRL
              document).

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