Gebauer keratome gets FDA approval

February 18, 2009

The Gebauer SL Keratome, a sterile single-use instrument for performing Epi-LASIK and LASIK surgeries, has received FDA clearance and can now be distributed for sale in the US.

The SL Keratome, a sterile single-use instrument for performing Epi-LASIK and LASIK surgeries, has received FDA clearance and can now be distributed for sale in the US.

As it is a single-use product, the SL Keratome does not require repeated cleaning, which reduces cycle times and provides a more convenient option for the surgeon. The easy-to-use ergonomic design features a simple foot pedal control as well as a "Click And Go" set-up. In addition, the handpiece of the SL does not need to be moved during surgery, allowing the surgeon to perform epithelial separations as well as LASIK surgery.

The SL Keratome received CE mark approval in August 2008.