Health Canada — Medical Devices · Canada · 2015-04-27 · Type III
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Reported risk: A discrepancy in subject device product labeling exists. The programmed software settings were determined to be higher than those required for the model of hand piece deployed on patients. An examination of subject device light sheer desire laser system labeling found the physician recommended treatment settings did not match the settings identified by the subject device software when specific patient skin types and hair color were selected. An inexperienced device operator would not be aware the treatment settings identified by the system software are incorrect.
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