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Bausch & Lomb Stellaris PC

This article was originally published in The Gray Sheet

Executive Summary

Firm announces Aug. 19 510(k) clearance of its Stellaris PC (Procedural Choice) vision enhancement system for cataract, retina and combined cataract/retina surgery. The product is a combined vitrectomy and phacoemulsification system. Stellaris was originally cleared in 2007 for cataract surgery only; the new multi-procedure system gained CE mark approval in May (1"The Gray Sheet" Aug. 23, 2010)

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Bausch & Lomb's Stellaris PC: Company debuts its Stellaris PC (Procedural Choice) vision enhancement system overseas following CE mark approval last May. The combined vitrectomy and phacoemulsification system, for which a May 510(k) submission remains pending at FDA, enhances surgeons' ability to see ocular tissue under various surgical conditions, B&L claims. Stellaris PC is indicated for emulsification and removal of cataracts, and anterior and posterior segment vitrectomy

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