Petition to revise GHR’s FDA clearance

Petition to revise GHR’s FDA clearance

On 26 October 1998, the US Food and Drug Administration (FDA) reclassified electric tweezers like GHR, stating "there is no statistically significant scientific data available at this time to support promotional claims of permanent or long-term removal of hair."

FDA tweezer reclassification (full text)

This left several questions regarding the status of two electric tweezers, AHRS and GHR, which had claimed for many years to be substantially equivalent to needle-type epilators.

On 19 May 1999, I submitted a petition to FDA asking them to clarify their position and to rescind AHRS and GHR clearance as substantially equivalent to needle epilators.

On 5 January 2000, FDA responded:

The initial classification of the AHRS Epilator 629, as a needle-type epilator, was made in error. We corrected this mistake shortly after we determined the device to be substantially equivalent to a preamendment tweezer-type epilator. We accomplished the correction by issuing a revised order to the manufacturer that reflects the proper classification of the device. Concerning the GHR System, our records show that the device was not cleared for marketing as a needle-type epilator, but was also cleared as a tweezer-type epilator.

Therefore, your request is based on an erroneous assumption that these devices have been found substantially equivalent to needle-type epilators.

On 11 February, I asked FDA to clarify comments made by reviewer Paul Tilton in his review of GHR.

On 10 April 2000, FDA replied:

If there is any question as to which predicate device the product was found equivalent, an examination of the clearance letter dated August 5, 1991 that was sent to the company reveals that the class of the device as originally cleared was class III. This classification corresponds to the classification of the Tweezer-Type Epilator. Therefore, this device was cleared originally as a class III Tweezer-Type Epilator.

In other words, GHR was never considered by FDA to be substantially equivalent to needle epilators.

You can download my petitions at FDA’s website (warning: extremely large .PDF files– requires Adobe Acrobat):

Docket 99P-1615 (GHR petition)

Docket 99P-1614 (AHRS petition)