Removatron 515(i) The following summarizes safety and efficacy data submitted on
24 September 1996 by electric tweezer manufacturer Removatron
as part of FDA's reclassification of electric tweezers.
FDA reviewed Removatron's information as Reference 3 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"The agency described the results of two unpublished studies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)
Helene Edgar 515(i)
submission
Removatron submitted 130 pages of data, most of which was about
safety. FDA was satisfied that the device was safe enough to warrant
reclassification, but they found the submission quite lacking
in terms of effectiveness of the device.
18 page overview
Efficacy
(14 pages) Unpublished report by
Nellie Konnikov using Removatron on 7 subjects with three-month
follow-up
(4 pages) Unpublished report by C. Stephen
Foster on Removatron on a mouse
(2 pages) From Hinkel commonly used by
tweezers to justify 3-month observation times
(4 pages) IGPE standards pamphlet commonly
used by tweezers to justify 3-month observation times
(4 pages) Removatron promotional material
claiming efficacy
Depilatron data (a similar device, available
before Removatron came on the market)
- (1 page) A 1975 letter from FDA reviewing Depilatron promotional
literature and concluding it appears there is no reason to believe
the device may be hazardous
- (5 pages) From Harvey Glass on Depilatron, including sworn
deposition (unsigned, unwitnessed)
- (3 pages) From Melvin Shiffman on Depilatron including sworn
deposition (signed, notarized)
- (2 pages) From Walter Lever on Depilatron including sworn
deposition (signed, notarized)
Safety
(10 pages) 3 published medical articles
on microwave radiation and cataracts by Budd Appleton
(8 pages) C.V. of Budd Appleton
(3 pages) From Budd Appleton reiterating
safety of Removatron regarding cataracts
(7 pages) Certification of safety by Canadian
Standards Association (CSA)
(23 pages) From Cenelec on the device's
safety regarding pacemakers, and two on oscilloscopes used in
testing
(8 pages) Galinsky published medical article
on needle electrolysis.
(1 page) AMA brochure on unwanted hair
(1 page) Newspaper article on man who may
have contracted HIV from a tattoo (implying needle electrolysis
with unsterilized reused probles is unsafe)
(8 pages) From electrolysis book by Julius
Shapiro, with pacemeker data highlighted
(1 page) Trade magazine International Hair
Route article on electric tweezers
(2 pages) Saftey checklist used for Removatron
machines
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hair removal
facts
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