The U.S. Food and Drug Administration (FDA) regulates medical devices in the U.S. The FDA keeps extensive databases on these devices containing lists of the devices, their safety records, pre-market notifications, and pre-market approval notices, to name a few.
Section 510(k) of the Food, Drug and Cosmetic Act requires regulated medical device manufacturers to notify the FDA at least 90 days in advance of their intent to market a medical device. This is known as Premarket Notification — also called PMN or 510(k). It allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories.
This allows „new“ (unclassified) devices (those not in commercial distribution prior to May 28, 1976) to be properly identified. Specifically, medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time.
The 501(k) notification must also be submitted when reintroducing a device that has been significantly changed or modified to the extent that its safety or effectiveness could be affected. These changes or modifications might relate to the design, material, chemical composition, energy source, manufacturing process, or intended use of the device.
The FDA has established classifications for approximately 1,700 different generic types of devices. These devices are grouped them into 16 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes (Class I, II or III) based on the level of control necessary to assure the safety and effectiveness of the device.
Call your laser hair removal clinic or doctor, and ask for the manufacturer, model, and 510(K) number of the medical device to be used in your cosmetic surgery procedure. The 510(K) number always starts with a „K“ and is the preferred item. Enter the 510(k) number into the appropriate field in the database search form.
An example of a 510(K) number is K002890. An example of a trade name or device name for that 510(K) number is „IntraLase 600C Laser Keratome.“ The intended use for this particular medical laser is eye surgery.
When the search results are returned, click on the link to the right of the „Summary“ line. The summary lists the characteristics of the laser device and when it was cleared for use. An approval letter should also be listed in the summary.
You may also wish to examine the FDA MAUDE (Manufacturer and User Facility Device Experience) database. This database contains reports of adverse events involving medical devices. The link to this database is http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.cfm
To Search the MAUDE listings by Brand Name, Manufacturer, Event Type, 510K Number, PMA Number, Product Code, or date, select use the Advanced Search button. No results were returned for the 510(K) number K002890, indicating that no adverse events were reported for that medical laser device during the reporting period.
The chances are very high that a licensed doctor will be using a licensed and approved laser device for your laser hair removal or other cosmetic surgery. However, with the quantity of online data available to the public, it doesn’t hurt to check.
Remember that the FDA keeps safety records of many medical devices, not just those that use lasers. It is better to learn about possible complaints or problems with the medical device about to be used on you before the cosmetic surgery procedure, rather than afterwards.
Learn more about medical laser applications, especially laser hair removal, at the resources below.