Helene Edgar 515(i) The following summarizes safety and efficacy data submitted on
10 September 1996 by electric tweezer manufacturer Helene Edgar
as part of FDA's reclassification of electric tweezers.
FDA reviewed Helene Edgar's information as Reference 2 in their
Final Rule, and they concluded in Docket No. 97N-0199:
"The agency described the results of two unpublished studies
(Refs. 2 and 3) and evaluated these results as being only suggestive of effectiveness
in permanently removing hair. Thus, FDA
agrees with the comments that there is no body of significant
information establishing the effectiveness of the device to
permanently remove hair."
See also:
 Docket No. 97N-0199
(full text)
Removatron 515(i)
submission
Helene Edgar turned in a 30 page submission, 5 of which were
on efficacy.
Efficacy
(5 pages) Unpublished, uncontrolled anecdotal
report on 7 subjects treated for 8 weeks, with 4 weeks' observation
after last treatment. Compared to GHR, but not a controlled comparison
Safety
(11 pages) Safety testing report from CSA
(3 pages) on manufacture and training
(11 pages) Owner's Manual
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