BioLase Technology Inc. said Friday that the Food and Drug Administration sent a letter saying that the dental laser maker adequately addressed concerns about its Irvine plant.
Wall Street responded well, sending the Irvine-based company’s shares up about 9% in afternoon trading on Nasdaq.
BioLase received a warning letter Sept. 5 from the FDA’s district office after the agency inspected the plant. That letter said some aspects of BioLase’s manufacturing, packing, storage or installation of its devices didn’t conform to FDA requirements.
