FDA tweezer reclassification: Helene Edgar 515(i)

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"The agency described the results of two unpublished studies (Refs. 2 and 3) and evaluated these results as being only suggestive of effectiveness in permanently removing hair.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(5 pages) Unpublished, uncontrolled anecdotal report on 7 subjects treated for 8 weeks, with 4 weeks’ observation after last treatment.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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