HairFacts | Hair Removal Information
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Electric tweezer petition to FDA In 1989, electric tweezer manufacturer American Hair Removal Systems (AHRS) submitted FDA Docket K892514 to the U.S. Food and Drug Administration for an electric tweezer called the TE 629. This device used galvanic current and made claims of permanent hair removal. Following several failed submissions rejected by FDA reviewer Theodore … Continue reading “Electric tweezer petition to FDA”
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 … Continue reading “Petition to revise GHR’s FDA clearance”
FDA on GHR: Alderton, 1998 On 26 October 1998, "Katherine Cook" asked FDA to clarify their position on the status of the GHR electric tweezer following FDA’s electric tweezer reclassification. This FDA Final Rule states: FDA acknowledges that there is no statistically significant scientific data available at this time to support promotional claims of permanent … Continue reading “FDA on GHR permanence (Alderton 1998)”
Petition to revise AHRS’s FDA clearance On 26 October 1998, the US Food and Drug Administration (FDA) reclassified electric tweezers like AHRS, 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 … Continue reading “Petition to revise AHRS’s FDA clearance”
AHRS original 510(k) submission From the FDA 510(k) submission for the AHRS TE 629 (Docket K982514). Comparison to needle epilators, p. 1 pH data, p. 1 Notes: This data was plagiarized by competitor GHR in their sales material.
AHRS original 510(k) data Comparison of needle electrolysis and electric tweezers From the FDA 510(k) submission for the AHRS TE 629 (Docket K982514). Note: This data is nearly identical to data used by rival GHR on their "Kitty’s Consumer Beware" promotional site. Also from the AHRS FDA 510(k) submission: pH data
AHRS original 510(k) data pH data From the FDA 510(k) submission for the AHRS TE 629 (Docket K982514). Note: This data is nearly identical to data used by rival GHR on their "Kitty’s Consumer Beware" promotional site. Also from the AHRS FDA 510(k) submission: Comparison to needle epilators
U.S. Food and Drug Administration The U.S. Food and Drug Administration is responsible for regulating certain aspects of the marketing and labeling of hair removal products and devices. Drugs (CDER) 505(b) Approvals for drugs used in treating unwanted hair Medical devices (CDRH) This is done through FDA’s Center for Devices and Radiological Health (CDRH) … Continue reading “FDA and hair removal”
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. … Continue reading “FDA tweezer reclassification: Removatron 515(i)”
510(k) intended use statements: alexandrite lasers Below is a list of alexandrite lasers cleared by FDA. The intended use of each is quoted verbatim from FDA clearances, followed by the date the clearance was issued. Some devices have more than one intended use, because they submitted for additional clearance. [Name] — indicates alternate device or … Continue reading “FDA 510(k) Intended use statements: alexandrite lasers”