Friday, December 23, 2011
FDA Clears Equipment for Cat Surgery
"The California-based ophthalmology company OptiMedica
has received 510(k) market clearance from the US Food and Drug
Administration (FDA) for its 'Catalys' laser system to be used in two
key stages of cataract surgery," reports Optics.org. "The system, which combines optical coherence tomography (OCT) imaging
with a femtosecond laser, is now cleared in the US for capsulotomy –
where a circular incision is made in a patient’s lens capsule – and lens
fragmentation, where a damaged lens is softened in advance of its
removal. OptiMedica received CE mark approval for the same system earlier this
year, meaning that it can now market Catalys across both the US and the
European Union." Read more and see the video.
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