24.06.2024 07:22:54 - dpa-AFX: Alcon's Cataract Systems Unity VCS, Unity CS Get FDA 510(k) Clearance
WASHINGTON (dpa-AFX) - 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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