Alcon's Cataract Systems Unity VCS, Unity CS Get FDA 510(k) Clearance
(RTTNews) - Eye care company Alcon Inc. (ALC) announced Monday that UNITY Vitreoretinal Cataract System or VCS and UNITY Cataract System or CS have received U.S. Food and Drug Administration's 510(k) clearance.
The UNITY VCS console, when used with compatible devices, is indicated for use during anterior segment and posterior segment ophthalmic surgery. The UNITY CS console, when used with compatible devices, is indicated for use during anterior segment ophthalmic surgery.
Alcon said it has tested Unity VCS and Unity CS during investigational advisory wet lab sessions with more than 200 highly experienced surgeons from 30+ countries. Now with 510(k) clearance, Alcon will begin a thorough program to secure real-world feedback before commercial launch in 2025.
The company will continue with regulatory submissions later this year in markets across the globe. CE Mark is expected in early 2025.
Unity VCS and Unity CS introduce significant workflow efficiencies over Alcon's current market-leading systems, CONSTELLATION Vision System for vitreoretinal procedures and CENTURION Vision System with ACTIVE SENTRY for cataract surgery.
Unity VCS and Unity CS will be supported by Alcon's training, product maintenance and Services teams.
According to the firm, these are the latest innovations from the Alcon Vision Suite-a portfolio of innovative products designed to help Eye Care Professionals increase clinic and OR efficiency, and deliver exceptional patient experiences.
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