OptiMedica gets FDA clearance for cataract laser
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.
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 ...
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