FDA WARNING_LETTER - Caliber Imaging & Diagnostics, Inc.

On January 8, 2015, the FDA issued a Warning Letter to Caliber Imaging and Diagnostics, Inc. for marketing the Vivascope 1500, Vivascope 1500 Multilaser, and Vivascope 3000 without marketing clearance or approval, violating the Federal Food, Drug, and Cosmetic Act.

The Vivascope 1500 and Vivascope 3000 were cleared under K080788 for in vivo tissue imaging to assist clinical judgment. However, the firm's website promoted these devices for diagnosing skin cancers and monitoring therapeutic outcomes of skin cancer treatments, which are major changes to their intended use, rendering them adulterated (Section 501(f)(1)(B)) and misbranded (Section 502(o)) due to lack of new premarket notification (510(k)) or PMA/IDE.

The Vivascope 1500 Multilaser was marketed without any marketing clearance or approval, making it adulterated (Section 501(f)(1)(B)) and misbranded (Section 502(o)) for failing to submit a 510(k) notification.

Additionally, Caliber Imaging and Diagnostics, Inc. failed to fulfill annual registration and listing requirements for fiscal year 2014, including updating their company name from "Lucid, Inc