IMPORTANT NOTICE

For US customers:


• Saccadometer Plus and Saccadometer Advanced are considered by FDA as being Class II Medical Devices, which are available as Rx only equipment, meaning that US Federal Law restricts this device to sale by or on the order of a licensed healthcare practitioner. According to FDA definition: “Health care practitioner means a physician or other individual who is a health care provider and licensed under State law to prescribe drugs or devices”.
• Saccadometer Plus and Saccadometer Advanced are allowed to be marketed in USA, see listing under: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K152890
• As a consequence of being Class II Medical Device Saccadometer systems are not authorized for use as critical components in life support systems.
• Intended use of Saccadometer Plus and Saccadometer Advanced is stated as follows: The Saccadometer is a device, intended to measure the pattern of eye movement when viewing lateral visual stimulus and identify the individual time delays of moving the eyes toward the stimuli.
• Indication for use: Measuring temporal characteristics of saccadic refixation responses when viewing lateral visual stimulus and identifying the individual time delays of moving the eyes toward the stimuli.
• The attached references literature (list of exemplary publications) only exemplifies the potential applications of saccadic latency measurement, but does not provide the required evidence of Saccadometer’s safety and effectiveness.

  For customers outside USA:

• The Saccadometers are considered to be general purpose systems, intended for measuring individual temporal characteristics of saccadic refixation responses when viewing lateral visual stimulus.