Medical lasers
have been used for dermatology applications such as removal
of port wine stains, dark spots, tattoos, acne scars and
other blemishes for over a decade. Lasers are used for a
growing number of cosmetic procedures including hair removal,
treatment of wrinkles, and tooth whitening. For risk information
on the specific laser treatment that you are considering,
ask your physician or operator for the patient labeling
for the laser device.
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 http://www.fda.gov/cdrh/databases.html
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
1-888-INFO-FDA or 301-827-3990, fax your request to 301-443-9535
or send an e-mail to: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfDSMA/consumer-form.cfm.
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.
WRINKLE TREATMENT
Lasers are also being used to
treat wrinkles. Several manufacturers have received FDA
clearance to claim treatment of wrinkles, while others may
claim skin resurfacing. Patients have reported reddening
of the skin, which lasted from one to four months. Pain
was mild and could be treated with over-the-counter analgesics.
Consumers should bear in mind that skin abrasion, whether
achieved by lasers, chemicals or abrasive materials, means
removing one or more layers of skin, which can be painful
and could cause redness, swelling or scarring, depending
on how each person heals.
People considering this procedure
should consult a dermatologist or the manufacturer to determine
whether or not they would be good candidates. Be sure to
ask your dermatologist for a copy of the patient labeling
for the specific laser device used to understand the risks.
DENTAL TREATMENTS
Several manufacturers have received
clearance for argon and carbon dioxide lasers to activate
tooth-bleaching solutions and to treat gum disease. Several
lasers have clearance for hard tissue use on teeth. On May
7, 1997 FDA cleared the first laser system for treating
tooth decay, an erbium YAG laser made by Premier Laser Systems.
Recently, American Dental Technologies received FDA clearance
to market its laser for caries removal; it is not cleared
to remove tooth enamel.
Studies conducted by the manufacturers
showed that the laser is as safe and effective as a high-speed
drill for removing dental decay and preparing a cavity for
a filling. The manufacturer's study indicated that fewer
patients needed anesthetic for pain. Any inquiries regarding
this method of cavity treatment should be directed to your
dentist, who can provide you with patient labeling including
risks for the specific laser.
EYE SURGERY
Lasers may be used to remove
tissue in eye surgery as well. This may include removing
tumors, cataracts, or proliferating blood vessels common
to diabetic retinopathy. Several manufacturers have lasers
cleared for photorefractive keratectomy (PRK) and Laser-Assisted
In Situ Keratomileusis (LASIK), two procedures for correcting
nearsightedness, farsightedness, and astigmatism. The laser
is used to reshape the cornea and focus images correctly
on the retina. For information on eye surgery and which
lasers have received clearance, you can access FDA's Website
at: http://www.fda.gov/cdrh/LASIK/.
As with the other types of patient labeling, be sure to
ask the surgeon for the patient labeling for the specific
laser device being used.
OTHER
MEDICAL USES
Some lasers have been cleared
for medical uses such as removing tissue. Because heat from
lasers cauterizes blood vessels, there is less bleeding
compared to scalpel use. Usually, FDA gives manufacturers
general surgical clearances; in order to promote the laser
for a specific surgical procedure, manufacturers must first
provide FDA with clinical evidence that their lasers are
safe and effective for that specific procedure. If you wish
to learn whether a specific laser has been cleared for a
specific indication, you may contact FDA's Consumer Staff.
You will need to provide the name of the manufacturer and
the specific product name of the device before contacting
the Consumer Staff.
PRACTITIONERS
States regulate who can use
lasers for various therapeutic procedures. Medical lasers
are prescription devices available for sale only to licensed
practitioners. You should check with your state medical
licensing board to determine who qualifies as a licensed
practitioner in your state.
BIOSTIMULATION LASERS
Biostimulation lasers, also called low level
laser therapy (LLLT), cold lasers, soft lasers, or laser
acupuncture devices, were cleared for marketing by FDA through
the Premarket Notification/510(k) process as adjunctive
devices for the temporary relief of pain. These clearances
were based on the presentation of clinical data to support
such claims. FDA will consider similar applications for
these and other claims with the decision to require clinical
data being made on an individual basis, taking into consideration
both the device and the claim. Please note that FDA law
and regulations contain provisions that permit limited distribution
of unapproved devices for use in clinical investigations.
There are numerous clinical investigations being conducted
in this and other countries to determine safety and efficacy
with these devices for the intended uses that are proposed.
Certain unapproved, nonsignificant risk
Class III medical devices, including biostimulation lasers,
may only be distributed in the U.S. to individual practitioners
who have approval from an Institutional Review Board (IRB)
for the investigational clinical use of the device, or to
investigators participating in a study under an Investigational
Device Exemption (IDE) approved by the Center for Devices
and Radiological Health (CDRH), as specified in the Code
of Federal Regulations (CFR), 21 CFR 812. Even with IRB
approval, a sponsor must comply with IDE requirements such
as monitoring investigations, maintaining records, making
reports, and complying with prohibitions on promotion and
commercialization of investigational devices. The investigators
would have similar responsibilities, also covered in 21
CFR 812.
LASER
RADIATION SAFETY
All laser devices distributed
for both human and animal treatment in the U.S. are subject
to Mandatory Performance Standards. They must meet the Federal
laser product performance standard and must submit an "initial
report" to CDRH's Office of Compliance prior to distributing
the product (see 21 CFR 1000-1040.11). This performance
standard specifies the safety features and labeling that
all laser products must have in order to provide adequate
safety to users and patients. A laser product manufacturer
must certify that each model complies with the standard
before introducing the laser into U.S. commerce. This includes
distribution for use during clinical investigations prior
to device approval.
Certification of a laser product
means that each unit has passed a quality assurance test
and that it complies with the performance standard. The
firm that certifies a laser product assumes responsibility
for product reporting, recordkeeping, and notification of
defects, noncompliances, and accidental radiation occurrences,
as specified in sections 21 CFR 1000-1010. A certifier of
a laser product is required to report the product via a
Laser Product Report submitted to CDRH. Reporting guides
and related regulatory information are available from the
DSMA web site at: http://www.fda.gov/cdrh/devadvice/.
Distribution of any certified laser products internationally
would also require submission of the report.
