FDA WARNING_LETTER - Hyperion Medical Technologies Inc

On November 20, 2013, the FDA issued a Warning Letter to Scott Day, US Agent for Blueshine/Hyperion Medical, regarding the unauthorized marketing of surgical lasers, HyperBlue 1530 and Blueshine Gold Series, in the United States.

The FDA determined these devices are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because the firm lacks an approved premarket approval (PMA) or investigational device exemption (IDE). They are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), for failure to submit a 510(k) notice for significant modifications.

Specifically, the Blueshine Gold Series, cleared under K110375 for 980 nm, was modified to claim 940 nm, 808 nm, and 532 nm wavelengths, individually or in combination. The HyperBlue 1530 device had a 15mm hand piece added. These modifications introduce new safety and effectiveness questions, requiring new 510(k) submissions.

Hyperion Medical is required to immediately cease commercial distribution of these devices for the discussed uses. The firm must respond in writing within