|*In Europe (EU), intraoperative fluorescence technologies are in compliance with the requirements of the European Medical Device directive 93/42/EEC. In the United States, INFRARED 800™ and BLUE 400™ fluorescence technologies have been completely integrated into the OPMI Pentero® and OPMI Pentero® C microscopes and both fluorescence platforms are available for sale. They are also available in other markets, however, depending on national regulations, additional authorization may be necessary in the country in which the instrument and application will be used. BLUE 400 image obtained with investigational new drug. |
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