AHRS 510(k) submission


AHRS submitted data to FDA claiming substantial equivalence to needle electroysis. On their fourth attempt, AHRS was cleared based on four unpublished, anecdotal, in-house reports with no peer review, discussing nine human subjects, four of whom were observed less than one hour.

Comparison to needle epilators, p. 1

pH data, p. 1

Leave a Reply

Your email address will not be published. Required fields are marked *

You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <s> <strike> <strong>