|
|
 |
|
FDA FACT SHEET |
|
|
|
HAIR
REMOVAL
The
popularity of laser hair removal has increasingly grown,
prompting many laser manufacturers to conduct research and
seek FDA clearance for their lasers for this indication. The
market is growing so quickly that FDA cannot maintain an
up-to-date list of all laser manufacturers whose devices
have been cleared for hair removal, as this list continues
to change. To learn if a specific manufacturer has received
FDA clearance, you can check FDA's Website at
Medical Device
Databases
under the 510(k) database. You will need to know the
manufacturer or device name of the laser. You can also call
FDA's Center for Devices and Radiological Health, Consumer
Staff, at 240-276-3103, fax your request to 240-276-3151 or
send an e-mail to:
DSMICA@cdrh.fda.gov.
Manufacturers should be aware that receiving an FDA
clearance for general permission to market their devices
does not permit them to advertise the lasers for either hair
removal or wrinkle treatment, even though hair removal or
wrinkle treatment may be a by-product of any cleared laser
procedure. Further, manufacturers may not claim that laser
hair removal is either painless or permanent unless the FDA
determines that there are sufficient data to demonstrate
such results. Several manufacturers received FDA permission
to claim, "permanent reduction," NOT "permanent removal" for
their lasers. This means that although laser treatments with
these devices will permanently reduce the total number of
body hairs, they will not result in a permanent removal of
all hair. The specific claim granted is "intended to effect
stable, long-term, or permanent reduction" through selective
targeting of melanin in hair follicles. Permanent hair
reduction is defined as the long-term, stable reduction in
the number of hairs re-growing after a treatment regime,
which may include several sessions. The number of hairs
regrowing must be stable over time greater than the duration
of the complete growth cycle of hair follicles, which varies
from four to twelve months according to body location.
Permanent hair reduction does not necessarily imply the
elimination of all hairs in the treatment area.
FDA does
not make comparisons between systems or how well or safely
they work compared to another company's system. FDA does not
recommend one laser system over another.
Lasers
cleared for body hair removal are also cleared for facial
hair removal.
|
|
Information above can be found at |
|
http://www.fda.gov/Radiation-EmittingProducts/ResourcesforYouRadiationEmittingProducts/ucm252761.htm |
|
|
| |
|
|
|

|
| |
|
 |