Vitrectomy system gains 510(k) clearance

O’Fallon, MO-Synergetics USA Inc. has received 510(k) marketing clearance from the FDA for its proprietary vitrectomy system (VersaVIT).

“The entry of [of our vitrectomy system] into the global vitrectomy market is a major milestone in Synergetics’ strategy to enter into higher growth areas of retinal surgery,” said David M. Hable, Synergetics’ president and chief executive officer. “We believe that [this system] is a ‘game changer’ given its functionality, portability, and competitive pricing relative to traditional vitrectomy systems.”

The vitrectomy system is under review for CE mark approval.

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