An Update on Aesthetic Medical Devices
It never ceases to amaze me how many medical products are marketed for
use to the non-medical market. There are
so many skin care products making outrageous claims and product manufacturers
making claims about their devices and all the while, marketing them to people who
cannot legally perform services with the device. This problem is more prevalent
today than ever before and this is counter intuitive since there has never been
more regulation in the health industry and the FDA has stepped up compliance.
I have previously written about skin care products that claim to alter
and repair DNA (this is really funny because it is so outrageous); other
products that claim to treat rosacea (even though when you read the package insert
it refers to treating “redness”) and devices that are marketed to the aesthetic
market when they are being offered to treat medical conditions. Sometimes the problem is that the device is a
medical device being offered to non-medical markets. Other times the problem is
that the device is treating medical conditions or the use of the device is such
that it constitutes the practice of medicine.
I was reading Day Spa magazine today and I ran across an advertisement
that I have seen for MANY years. It was for the Lamprobe. Interestingly enough,
I met the owner about ten years ago and asked how he is marketing the device to
the non-medical market. He had an unsatisfactory answer. It is not my intention to malign any
particular product, but this one typifies the problem.
The Lamprobe advertises that it treats skin tags, broken capillaries, cholesterol
deposits, cherry angiomas, fibromas, spider nevi, clogged pores and milia. Very interesting. An esthetician can treat
NONE of these proposed uses. How can
this product be ethically marketed to the non-medical aesthetic market when the
user cannot legally perform the treatments?
Virtually all of these proposed uses are outside the scope of license of
an esthetician and they are clearly and squarely within the parameters of
medicine.
Paddy Deighan JD PhD
http://www.medicalandspaconsulting.com
Medical Spa Lawyer 
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