Just checked the FDA site. It seems that your link to the FDA showing "approval" was not totally reported. Here is some extra information I copied and pasted that was not included on your website. Note the highlighted red part. I am seeing FDA APPROVED boldly stated on your website, but nowhere do I see this on the FDA website. Did you mean to say cleared by the FDA? I think this means that the FDA is saying that the product is reasonably safe, but in no way are they endorsing it for permanent hair removal. I think your website is misleading and you really should take corrective action. It would be in the interest of the consumer to do this.
Here is the complete link: http://www.fda.gov/ohrms/dockets/98fr/102698a.txt
And here is the part I chose to copy and paste:
In the Federal Register of June 11, 1997 (62 FR 31771), FDA issued
a proposed rule to reclassify the tweezer-type epilator from class III
to class I based on new information respecting such device. FDA also
proposed to exempt the device from premarket notification procedures.
Interested persons were given until September 9, 1997, to comment
on the proposed rule. During the comment period, FDA received 10
comments. One comment supported the proposed reclassification from class III to class I without providing any specific reason for endorsing the proposed reclassification. Nine comments were opposed to the proposed reclassification.
1. Two comments raised concerns about the device's safety. They
stated that the device could cause burns and scars on the skin if it
was improperly manufactured or used. One of these comments mistakenly
believed that FDA was also proposing that the device be exempt from the
current good manufacturing practices (CGMP's) regulation.
FDA agrees that improper manufacturing and use of the device could
result in burns and scars on the skin. FDA also is clarifying for the
record that the device was not proposed to be exempt from the CGMP's
regulation (21 CFR part 820). FDA, however, believes that these risks
can be controlled by general controls such as the CGMP requirements and
2. Eight comments (from professional associations, a professional
magazine, practitioners, a former patient, and a manufacturer) opposed
reclassification because they believe the device is not effective in
permanently removing unwanted hair. Four of these eight comments stated
that there are no published scientific data demonstrating that the
device permanently destroys hair. Three of these comments stated that
hair is a dielectric material, i.e., a nonconductor of electricity so
that it is impossible for electricity to descend through the hair to
the dermal papilla and destroy it. Two of these three comments stated
that there is no evidence that the device destroys the dermal papilla
of hair. Another comment indicated that the effectiveness claims for
the device are anecdotal and that there is much information that the
device is ineffective. FDA acknowledges that the published literature contains no evidence
of statistically significant data showing that the device is effective
in achieving permanent removal of hair. In the proposed rule, FDA
described the one published study using the device (Ref. 1) that
reported that the difference in the hair counts before and after
treatment was not significant. Also in the proposed rule, 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.
still believes that the device can be reclassified into class I,
because claims for the device can be addressed by the misbranding
provision of section 502 of the act (21 U.S.C. 352).
3. Three comments stated that the first sentence of the revised
identification statement that ``the tweezer-type epilator is a device
intended to remove hair by destroying the papilla of a hair'' is
misleading because the phrase ``destroying the papilla of a hair'' is
equivalent to stating the device permanently removes hair. They pointed
out that this phrase is part of the identification statement of another
device intended to remove hair, the needle epilator, 21 CFR 878.5350.
Although there is no universally accepted medical definition of
what constitutes permanent removal of hair, FDA acknowledges that the
phrase ``destroying the papilla of a hair'' is widely accepted by many
to be equivalent to stating the device permanently removes hair. FDA
now believes that the use of this phrase in the device identification
statement was inaccurate, and in this final rule, is removing this
phrase from the device identification.
4. Six comments related to the promotional material for the device.
They stated that this material frequently contains false and misleading
claims, specifically that the device is effective for permanent or
long-term removal of hair. Five of these six comments also stressed
that it is FDA's duty to protect the public from false and misleading
claims regarding a product's effectiveness and that reclassification
into class I could increase the number of such claims.
FDA takes seriously its responsibility to protect the public from
false and misleading claims about a product's effectiveness; however,
false and misleading claims may be controlled by
a general control, namely the misbranding provision of section 502 of
the act. Additionally, FDA acknowledges that there is no statistically
significant scientific data available at this time to support
promotional claims of permanent or long-term removal of hair through
use of the device.
II. FDA's Conclusion
FDA has concluded based on review of the available information that
use of the tweezer-type epilator removes hair and that use of the
device does not present a potential unreasonable risk to the public
health. FDA has also concluded that general controls would provide
reasonable assurance of the safety and effectiveness of the device, and
therefore, the device should be regulated as a class I device.
On November 21, 1997, the President signed FDAMA into law. Section
206 of FDAMA, in part, added a new section 510(l) to the act (21 U.S.C.
360(l)). Under section 501 of FDAMA, new section 510(l) became
effective on February 19, 1998. New section 510(l) provides that a
class I device is exempt from the premarket notification requirement
under section 510(k) of the act, unless the device is intended for a
use which is of substantial importance in preventing impairment of
human health or it presents a potential unreasonable risk of illness
injury (hereafter ``reserved criteria''). FDA has determined that the
device does not meet the reserved criteria, and, therefore, it is
exempt from the premarket notification requirements.
FDA also notes that 21 CFR 878.9(a), Limitations of exemptions from
section 510(k) of the act, requires manufacturers to submit a premarket
notification for any tweezer-type epilator whose intended use is
different from the intended use of legally marketed tweezer-type