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Aquavit Pharmaceuticals was found marketing two medical devices—the AQUAGOLD® fine touch microchannel microinjector and the A.S.A.P! Micro Infusion System—without required FDA premarket approval (PMA) or investigational device exemption (IDE) authorization. The devices were determined to be adulterated under federal law because the company lacked approved applications for commercial distribution, and were also misbranded because the firm failed to submit the required 510(k) notification of intent to introduce the devices into commerce. Both devices were marketed through the company's websites for delivering therapeutic solutions into skin for various aesthetic and medical concerns.