Biolase Clears Up FDA Concerns

Biolase (BLTI Quote) said it believes it has resolved Food and Drug Administration concerns that resulted in a warning letter earlier this month.

The Irvine, Calif., dental laser company said Sept. 11 that an FDA letter indicated certain aspects of the manufacture, packing, storage or installation of the company's devices were not in conformance with the FDA's current Good Manufacturing Practice requirements for medical devices.

On Friday, the company said it got a letter from the FDA stating that the FDA had completed its review of the company's response. The FDA reported that the company's response adequately addressed the FDA's concerns.