FDA tweezer reclassification: Removatron 515(i)

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"The agency described the results of two unpublished studies (Refs. 2 and 3) and evaluated these results as being only suggestive of effectiveness in permanently removing hair.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(14 pages) Unpublished report by Nellie Konnikov using Removatron on 7 subjects with three-month follow-up

(4 pages) Unpublished report by C. Stephen Foster on Removatron on a mouse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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