Vitrectomy system gains 510(k) clearance

July 5, 2012
Ophthalmology Times Staff Reports

Synergetics USA Inc. has received 510(k) marketing clearance from the FDA for its proprietary vitrectomy system (VersaVIT).

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.

For more articles in this issue of Ophthalmology Times eReport, click here.