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Quality Focus

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Our dedicated motto is: “WE FOCUS ON PERFECTION”. This implies high demands on the quality of our human, and technical performance. Everyday we struggle hard in order to optimize our processes, and products.Thereby facilitating surgeon’s daily work, and improving patient’s visibility.

20/10 PERFECT VISION operates a quality management system in compliance with the international standards of ISO 9001:2000, and ISO 13485:2003. This extremely high quality standard is crucial to our success in the highly competitive medical technology market.



CE Mark
Our FEMTEC Laser Workstation, as well as the necessary accessories, like the Patient Interface, are in compliance with the European Directive MDD 93/42/EEC for medical devices, and may be traded without restriction throughout the European economic area.

FDA 510(k) Clearance
FDA 510(k) clearance for the FEMTEC Laser Workstation has been received for the use in creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.

International Availability
20/10 PERFECT VISION holds some international registrations for selected markets.

For detailed information please contact our Sales Department.


 
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