Spectral optical coherence tomography device earns 510(k) clearance

April 15, 2008

Reichert Inc. has received 510(k) clearance from the FDA to market its spectral optical coherence tomography (OCT) system (Optopol SOCT Copernicus) in the United States.

Depew, NY-Reichert Inc. has received 510(k) clearance from the FDA to market its spectral optical coherence tomography (OCT) system (Optopol SOCT Copernicus) in the United States.

The system, which produces high-resolution, three-dimensional images of the retina, was the first commercially available spectral OCT ophthalmic imaging device in the world market, according to a statement released by the company.

"The introduction of [the system] is a continuation of our growth strategy of adding high-technology, diagnostic instruments to our product portfolio," said Tim Levindofske, president and chief executive officer of Reichert. The company expects the device to be well received by eye-care physicians in the United States, he added.