Cole 510(k), 1990 (unpublished)

Cole, 1990

Electric tweezer American Hair Removal System (AHRS) was cleared to market by FDA in August 1990, based on four unpublished, anecdotal, in-house reports with no peer review. These reports submitted by owner Lee Cole discuss nine human subjects, four of whom were observed for less than one hour.

AHRS made three attempts before being cleared by FDA, characterized by FDA as "very deficient," "theoretically impossible," and "inconceivable," respectively.

Their fourth attempt contained four unpublished, anecdotal, in-house reports:

pH analysis of hair: This poorly-designed test is meaningless because samples are contaminated in the course of the experiment.

Synopsis of conduction study: This poorly-designed test contains contaminated data with no controls for variables in the circuit being tested.

Comparison of effectiveness: This test is based on a 9-week observation period, and the scientific protocol is based on a 4-page sales brochure.

Microscopic analysis: This test was conducted by someone claiming to be a "dermologist," which fooled FDA reviewers into thinking he was a dermatologist. There is no such medical specialty as "dermology."

FDA stated in 1998 that there is no body of significant information establishing the effectiveness of electric tweezers to permanently remove hair.

FDA’s decision has left some unanswered questions about the status of what AHRS can and cannot claim. I have analyzed this faulty submission and reported my findings to FDA in a petition for administrative reconsideration.

Download my full AHRS petition from FDA’s website (warning: extremely large Adobe Acrobat file– 11.6 MB)

http://www.fda.gov/ohrms/dockets/dailys/052699/prc0001.pdf

99P-1614 PRC for K892514 Epilator 629 by American Hair Removal System

In addition, a copycat tweezer called the Guaranty Hair Removal System (GHR) claims AHRS data submitted to FDA is theirs.

Discussion of GHR/AHRS disputed data

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