Is Your Doctor's Hair Removal Laser Safe?

.S. Food and Drug Administration (FDA) regulatesthe medical device to be used in your cosmetic
medical devices in the U.S. The FDA keeps extensivesurgery procedure. The 510(K) number always starts
databases on these devices containing lists of thewith a "K" and is the preferred item. Enter the 510(k)
devices, their safety records, pre-marketnumber into the appropriate field in the database
notifications, and pre-market approval notices, tosearch form.
name a few.An example of a 510(K) number is K002890. An
Section 510(k) of the Food, Drug and Cosmetic Actexample of a trade name or device name for that
requires regulated medical device manufacturers to510(K) number is "IntraLase 600C Laser Keratome."
notify the FDA at least 90 days in advance of theirThe intended use for this particular medical laser is
intent to market a medical device. This is known aseye surgery.
Premarket Notification -- also called PMN or 510(k). ItWhen the search results are returned, click on the
allows FDA to determine whether the device islink to the right of the "Summary" line. The summary
equivalent to a device already placed into one of thelists the characteristics of the laser device and when
three classification categories.it was cleared for use. An approval letter should also
This allows "new" (unclassified) devices (those not inbe listed in the summary.
commercial distribution prior to May 28, 1976) to beYou may also wish to examine the FDA MAUDE
properly identified. Specifically, medical device(Manufacturer and User Facility Device Experience)
manufacturers are required to submit a premarketdatabase. This database contains reports of adverse
notification if they intend to introduce a device intoevents involving medical devices. The link to this
commercial distribution for the first time.database is
The 501(k) notification must also be submitted whenTo Search the MAUDE listings by Brand Name,
reintroducing a device that has been significantlyManufacturer, Event Type, 510K Number, PMA
changed or modified to the extent that its safety orNumber, Product Code, or date, select use the
effectiveness could be affected. These changes orAdvanced Search button. No results were returned
modifications might relate to the design, material,for the 510(K) number K002890, indicating that no
chemical composition, energy source, manufacturingadverse events were reported for that medical laser
process, or intended use of the device.device during the reporting period.
The FDA has established classifications forThe chances are very high that a licensed doctor will
approximately 1,700 different generic types ofbe using a licensed and approved laser device for
devices. These devices are grouped them into 16your laser hair removal or other cosmetic surgery.
medical specialties referred to as panels. Each ofHowever, with the quantity of online data available to
these generic types of devices is assigned to one ofthe public, it doesn't hurt to check.
three regulatory classes (Class I, II or III) based onRemember that the FDA keeps safety records of
the level of control necessary to assure the safetymany medical devices, not just those that use lasers.
and effectiveness of the device.It is better to learn about possible complaints or
This 510(K) database can be searched by 510(k)problems with the medical device about to be used
number, applicant, device name or FDA product code.on you before the cosmetic surgery procedure,
The database is updated monthly and is found onlinerather than afterwards.
atLearn more about medical laser applications, especially
Call your laser hair removal clinic or doctor, and asklaser hair removal, at the resources below.
for the manufacturer, model, and 510(K) number of