FDA clears adjustable chandelier for Stellaris PC Vision Enhancement System
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Bausch + Lomb received FDA 510(k) clearance for an adjustable chandelier fiber optic illuminator in 23- and 25-gauge versions for the Stellaris PC Vision Enhancement System, according to a press release.
The chandelier can be used in several procedures, including bimanual surgery with the use of multiple instruments. It features controlled light adjustment, an adjustable fiber cable, secure placement with distal fiber and a 90° distal curvature to assist in placement.
“This enhancement will provide surgeons a ‘hands-free’ form of endoillumination as well as a wide field of light and a very convenient adjustment control,” Ari Kellen, MD, head of U.S. Eye Health at Bausch + Lomb, said in the release.
The device can work transsclerally or with the Entry Site Alignment valved cannulas, while allowing versatility and support in complex procedures, the release said.