Gebauer Medizintechnik GmbH Obtains CE Approval for its New Single Use SL Keratome
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NEUHAUSEN, Germany, August 3/ Gebauer announced that their new Gebauer SL Keratome for LASIK and Epi-LASIK procedures has received CE approval. The CE Mark indicates conformity to the legal requirements of the European Union (EU) Directive with respect to Medical Devices.
All product components making direct patient contact are single-use and sterile. Therefore, the Gebauer SL Keratome reduces potential problems due to wear and repeated cleaning and helps to decrease cycle times in the operating room. At the same time, the Gebauer SL complies with the strict sterilisation rules now applicable in many countries.
The ergonomic and light-weight SL Handpiece enables the surgeon to have a motionless hand while performing the surgical procedure. With the Gebauer SL, all current refractive operations can be performed: Epi-LASIK, Advanced Surface Ablation (ASA/PRK), LASIK, Thin-Flap-LASIK or SBK.
"The SL Keratome is the product breakthrough that refractive surgeons have been asking for: simplicity, versatility, and single-use at a small investment," said Steffen Gebauer, Gebauer's Managing Director. "We are very pleased to bring our smart new SL Keratome to European surgeons. The motionless handpiece grip, simple foot pedal control, intelligent Click-And-Go set-up and the complete single-use set with stainless steel vacuum ring are a unique product package."
During the past 29 years, Gebauer has gained a wealth of experience in turning new technology ideas into fully developed products that deliver superior and affordable performance. A privately held company based in Neuhausen, Germany, Gebauer brings precision engineering design, component integration, electronics development, software creation and the highest level of quality assurance to its entire medical device manufacturing.
The Gebauer EpiVision(TM) System with MicronEdge(TM) Separator is the technologically leading product for Epi-LASIK and Advanced Surface Ablation procedures.
The Gebauer SL is a high quality, ergonomic, single-use keratome for use in all currently applied refractive techniques.
For more information contact:
Steffen Gebauer
Gebauer Medizintechnik GmbH
Monbachstrasse 7/1
75242 Neuhausen
Germany
Tel: +49-(0)7234-9421-0
Fax: +49-(0)7234-9421-20
e-mail: info@gebauer-sl.com
Source: Gebauer Medizintechnik GmbH
