Stephens 510(k), 1990 (unpublished)

Stephens, 1990

Electric tweezer AHRS was cleared to market by FDA in August, 1990. Three months after AHRS was cleared, a copycat device called GHR was submitted to FDA (November, 1990).

As with the AHRS submission, Guaranty Hair Removal manufacturer Judith Stephens submitted unreviewed in-house reports as part of GHR’s electric tweezer submission to FDA.

Because there are no published clinical studies on electric tweezers that demonstrate they can work as claimed, Stephens’ lawyer included four published articles on needle electrolysis in an attempt to connect the GHR tweezer with legitimate hair removal methods ( Richards, 1986 Hinkel, 1968 Kligman, 1984 Hobbs, 1987). FDA didn’t buy it.

GHR’s unreviewed in-house efficacy data is almost completely censored in the best available copy from FDA. Two studies cited by GHR in their submission actually show that GHR cannot work as claimed:

LeMaster 1990).

This unpublished report was sponsored by GHR and shows that electricity travels along the outer hair shaft, not through it.

Feughelman, 1982

As with LeMaster, this published study shows hair is a poor conductor of electricity.

Other unpublished reports also show that GHR cannot work as claimed

van Orden, 1998

van Orden states: "Soaking or coating the hair shaft with an electrolyte can, of course, provide a conductive path along the outside surface of the hair, but studies indicate that such applied current would likely dissipate through the skin at the follicle opening and not penetrate fully to the papilla. Any test of hair conductivity must eliminate the effects of possible current flow along the hair surface through a conductive coating."

Schuster, 1992

Unfortunately, LeMaster’s unpublished findings have little or no bearing on human hair as it would react on a live subject. LeMaster’s unpublished report concerns itself with the conductivity of hairs that are not in vivo.

Not only did GHR copy the AHRS tweezer design, they’ve even copied AHRS data submitted to FDA and claimed it as their own, stealing two of AHRS’s unpublished reports and passing them off as their own.

Discussion of GHR plagiarism

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 GHR can and cannot claim. I have analyzed this faulty submission and reported my findings to FDA in a petition for administrative reconsideration, which is currently under review.

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

http://www.fda.gov/ohrms/dockets/dailys/052699/prc001.pdf

99P-1615 PRC for K905125 Guaranty Hair Removal System by Stephens Mfg

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